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2024 Life Science Outlook Report



2024 Life Science Outlook Report

Are you poised to invest in the next big breakthrough in the life sciences? From biotech to pharmaceuticals, our report covers it all. Get expert analysis and top stock picks to guide your investment decisions.

✓ Trends ✓ Forecasts ✓ Top Stocks

Table of Contents:

  • Biotech Market Forecast: 3 Top Trends That Will Affect Biotech in 2024
  • Biotech Market Update: Q1 2024 in Review
  • Top 5 NASDAQ Biotech Stocks
  • Top 3 Canadian Biotech Stocks
  • Pharma Market Forecast: 3 Top Trends That Will Affect Pharma in 2024
  • Top 5 NASDAQ Pharma Stocks
  • Top 3 Canadian Pharma Stocks
  • How to Invest in Medical Devices
  • Top 5 NASDAQ Medical Device Stocks
  • How to Invest in Genetics
  • Top 5 NASDAQ Genetics Stocks
Life Science Outlook 2024

A Sneak Peek At What The Insiders Are Saying

"There's plenty of innovation in our sector, especially in the hands of biotech companies. And once proof of concept is achieved, that becomes a very rarefied but unique class that pharma is very interested in talking to. And so these conversations are ongoing"
— Maha Katabi, Sofinnova Investments

"To outperform in this environment, leading (pharma) companies can seize this moment to 'reinvent for returns.' Companies with foresight will see 2024 as the year of delivering impressive results for both patients and investors."
— PWC

Who We Are

The Investing News Network is a growing network of authoritative publications delivering independent, unbiased news and education for investors. We deliver knowledgeable, carefully curated coverage of a variety of markets including gold, cannabis, biotech and many others. This means you read nothing but the best from the entire world of investing advice, and never have to waste your valuable time doing hours, days or weeks of research yourself.

At the same time, not a single word of the content we choose for you is paid for by any company or investment advisor: We choose our content based solely on its informational and educational value to you, the investor.

So if you are looking for a way to diversify your portfolio amidst political and financial instability, this is the place to start. Right now.


2024 Life Science Outlook Report.


Table of Contents


Biotech Market Forecast: 3 Top Trends That Will Affect Biotech in 2024

Biotech Market Update: Q1 2024 in Review

Top 5 NASDAQ Biotech Stocks

Top 3 Canadian Biotech Stocks

Pharma Market Forecast: 3 Top Trends That Will Affect Pharma in 2024

Top 5 NASDAQ Pharma Stocks

Top 3 Canadian Pharma Stocks

How to Invest in Medical Devices

Top 5 NASDAQ Medical Device Stocks

How to Invest in Genetics

Top 5 NASDAQ Genetics Stocks


Biotech Market Forecast: Top Trends That Will Affect Biotech in 2024

What biotech trends will shape the market's future in 2024? Experts weigh in with their forecasts for the new year.

Biotetch is a dynamic and constantly evolving industry that is driving scientific advancements and innovation in healthcare. According to Grandview Research, the global biotech market was worth US$1.55 trillion in 2023, and the firm expects it to grow at a CAGR of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.

The growth potential offered by the biotech sector means those who invest in the market can support companies that are making a positive impact on people’s lives while potentially generating significant returns.

Like many industries, the biotech market has seen slower growth in recent years. But heading into 2024, there are strong signals that the US Federal Reserve will cut interest rates after its aggressive hiking cycle. With that in mind, some biotech experts are optimistic that the sector could attract more investor interest and experience a period of growth in 2024. In fact, a recent survey conducted by GlobalData shows that 40 percent of the 115 respondents are optimistic that biotech funding will bounce back in 2024, while 60 percent are optimistic about the sector’s growth.

Read on to learn what key trends experts believe will shape the biotech industry in the coming year.


Personalized medicine to continue gaining traction

Personalized medicine, a growing trend in healthcare that involves tailoring treatments to individual patients based on their unique genetic and molecular profiles, is expected to be more prevalent in 2024, according to MicroMD.

Aiding the progress of personalized medicine is bioinformatics, a field within biotech that combines biology, computer science and statistics. Artificial intelligence (AI) has become a helpful tool for gathering bioinformatic data, and News Medical points to AI's effectiveness in processing more genomic datasets in less time than it would take humans.

Analysts at BioPharma Reporter predict that cell and gene therapies, promising forms of personalized medicine, will also be top trends in 2024, aided by the increasing availability of genetic data. In December 2023, the US Food and Drug Administration (FDA) approved Casgevy, the first-ever CRISPR-based therapy for treating sickle cell disease (SCD).

CRISPR is an innovative gene-editing technology with a variety of uses, including targeting and repairing the genetic mutation that causes SCD. Another gene therapy that was granted FDA approval last year is Lyfgenia, a cell-based treatment that can genetically modify a patient’s stem cells to produce healthy, round red blood cells.

In addition to FDA approval, Casgevy has been given conditional marketing authorization in the United Kingdom, and Vertex Pharmaceuticals (NASDAQ:VRTX), the company that makes the drug, plans to deliver 50 treatment centers in the US and 25 in Europe in 2024. Bluebird Bio (NASDAQ:BLUE), the firm that produces Lyfgenia, also reported positive momentum following the drug’s launch in its 2024 financial outlook report.

For its part, Editas Medicine (NASDAQ:EDIT) is currently running trials of its CRISPR-based therapies, Reni-Cel and EdiTHAL. The former is being tested as a treatment option for SCD and transfusion-dependent beta thalassemia, while the latter is being tested for treating tumors. Intellia Therapeutics (NASDAQ:NTLA) also has several CRISPR-based therapies in its pipeline that are geared at treating various genetic diseases.

CRISPR technology can also be used to modify cells used in tissue engineering or bioprinting, creating personalized tissues and organs for therapeutic purposes like transplants. This technology has been extensively researched and developed over the past decade, and recent improvements include a handheld bioprinting device built by a Canadian research team — it is able to print biocompatible structures inside the human body.

Bioprinting holds great potential for treating a range of conditions, including genetic disorders, cancers and diseases previously thought to be incurable. The ability to print organs and tissues will have a major impact on organ transplants, significantly reducing wait times for patients who need organs and lowering the risk of organ rejection, since the new organs will be custom made based on each patient's genetic makeup.


Experts eyeing progress in cancer immunotherapies

The field of cancer immunotherapy has made significant progress in recent years, due in part to advances in biotechnology, such as cell-based approaches like CAR-T cell therapy to treat certain types of cancer.

CAR-T therapy involves collecting T-cells, a type of white blood cell that helps protect the body against infections and cancers, from a patient's blood and then priming them to fight cancer cells more aggressively than natural T-cells.

The cells are genetically engineered to produce a chimeric antigen receptor (CAR) that targets a specific protein found in cancer cells. The cells are multiplied in a lab and then injected back into the patient to, essentially, enhance the patient’s immune system. In an interview with CTV Winnipeg, Dr. David Szwajcer, who has been working with the Canadian province of Manitoba to provide CAR-T therapy since January 2023, said the treatment has cured “a significantly larger number of people” compared to treatments that were available just five years ago.

While still in its early stages, CAR-T therapy is a promising area of cancer immunotherapy that has attracted significant interest from investors. The BioInformant’s 2024 CAR-T Financing Report shows that in the last 10 years companies working on CAR-T therapies have attracted a total of US$6.7 billion in venture capital investment and raised US$5.76 billion through their initial public offerings (IPOs). EY Global Life Sciences Deals Leader Subin Baral told Pharmaceutical Technology that CAR-T therapies likely hold the most investment potential within personalized medicine, although he clarified that the biggest investment surge is likely a few years away, indicating the potential for long-term growth.

However, while the FDA has approved six CAR-T therapies for treating certain types of leukemia and lymphoma, studies reveal a roughly 60 percent relapse rate after its administration. The FDA opened up an investigation in November 2023 looking into the risk of T-cell malignancy and secondary cancers following treatment. Research into the application of CAR-T for other forms of cancers and autoimmune and infectious diseases is ongoing.

For that reason, Subin expects more exploration of other therapies in the short term, such as antibody-drug conjugates (ADCs), which have an antibody linked to a cytotoxic payload that is released when the ADC binds to its target.

Antibody-based therapies, which are designed to have a targeted effect on cancer cells, have also been studied in different stages of clinical development. Roche (OTCQX:RHHBF,SWX:RO) subsidiary Genentech is currently investigating the effectiveness of its antibody-based drug, tiragolumab, when used in combination with Tecentriq. Genentech’s treatment targets a receptor referred to as TIGIT, shorthand for T-cell immunoreceptor with Ig and ITIM domains, which can sometimes inhibit the body’s immune response, allowing cancer cells to slip past undetected. Tiragolumab reportedly enhances TIGIT’s ability to detect and attack cancer cells, but the efficacy of TIGIT and its potential uses are still being studied, making this trial particularly noteworthy. Gilead Sciences (NASDAQ:GILD) is another company developing an ADC therapy, and it is currently running a Phase III trial of its therapy for lung cancer.

Overall, the development of novel cancer treatments represents an exciting area of research that has the potential to significantly impact patient outcomes and drive growth in the healthcare industry.


Biotechnology's growing applications in agriculture

Since world leaders gathered at COP28 to discuss solutions to the climate crisis and sustainable food systems, some experts have suggested biotech as a potential source of innovative solutions in agriculture. They believe biotechnology offers the tools to create a more resilient and sustainable food system.

Genetically modified crops that have been engineered to increase yield, enhance nutritional value and exhibit resistance to climate change have the potential to play a significant role in addressing the global food crisis, according to Kaiser Jamil, a biotechnologist and president of the Third World Organization for Women in Science. In her 2012 article for the United Nations, she points to the potential for biotech in relieving food shortages around the world.

Science has come along way since the article was published, and biotechnology is finding its way from healthcare to agriculture. For example, gene-editing technology can be used to develop new crop varieties or modify specific genes in crops to give them more desirable traits, such as higher nutritional value or drought tolerance.

Innovations in biotech have also led to advances in precision agriculture, which uses technologies like drones and sensors to optimize farming with the use of fewer pesticides and fertilizers; there's also vertical farming, which consists of growing crops in vertically integrated, climate-controlled environments. Aside from that, cellular agriculture is a form of biotechnology in which scientists produce lab-grown meat and dairy products. While it’s still early on, it has the potential to lighten the strain of demand for animal products on traditional farms.

Additionally, synthetic biology can be applied to create bio-based alternatives to non-biodegradable materials, and to genetically engineer microbes to assist in bioremediation.


Economic factors to watch in 2024

Gabe Cavazos of Leerink Partners described October as a brutal month for biotech companies while speaking at this year's Biotech Showcase, held in San Francisco in mid-January.

However, based on comments made at the conference, the economic landscape appears much more positive heading into 2024 following an influx of mergers and acquisitions (M&A) in November and December.

“The five M&A deals in December infused US$30 billion back into healthcare-dedicated funds. So that just provided more fuel for the fire,” Cavazos said at the event. The fourth quarter of 2023 brought six of the 10 largest biotech investment deals of the year, with four completed within the final five weeks of the year. First, AbbVie (NYSE:ABBV) announced plans to acquire Immunogen (NASDAQ:IMGN), along with its ADC cancer therapy Elahere for US$10.1 billion, on November 30. AbbVie later said on December 6 that it plans to buy Cerevel Therapeutics Holdings (NASDAQ:CERE), a biopharma company that specializes in therapies for neurological and neuropsychiatric disorders, for US$8.7 billion.

As mentioned, comments made by Fed Chair Jerome Powell following the central bank's December meeting have increased expectations that there could be interest rate cuts in 2024. This news may have fueled another round of M&A activity, this time by Bristol Myers Squibb (NYSE:BMY), which announced acquisition deals with Karuna Therapeutics (NASDAQ:KRTX) for US$14 billion on December 22, and with RayzeBio (NASDAQ:RYZB) just four days later for US$4.1 billion. Both transactions are expected to close within the first half of 2024.

The SPDR S&P Biotech ETF (ARCA:XBI) was up 8.26 percent since the Fed meeting as of January 17

“So all the signs are there that the inflationary pressures are waning — that the interest rate environment's going to be more conducive, and biotech’s directly correlated to the interest rate environment,” Cavazos said.

Will that momentum carry into 2024? Analysts are hopeful. EY’s 2024 M&A Firepower Report reveals that the top 25 biopharma companies have US$1.37 trillion to pursue growth opportunities through M&A or other strategic investments.

Speaking at the Biotech Showcase, Maha Katabi, a general partner at Sofinnova Investments, said pharma companies have a great need to replenish their pipelines. “There's plenty of innovation in our sector, especially in the hands of biotech companies. And once proof of concept is achieved, that becomes a very rarefied but unique class that pharma is very interested in talking to. And so these conversations are ongoing," she said.

So far in 2024, five biotech companies have announced IPOs, with the most recent being Kyverna Therapeutics, which is developing cell therapies for autoimmune diseases. Only 19 IPOs were announced throughout all of 2023, so five in less than three weeks could be indicative of a vibrant and innovative sector.


Investor takeaway

The long-term success of biotech companies will be dependent on their ability to bring valuable healthcare products to market, which in turn relies on their capacity to conduct innovative research and development and secure funding for clinical trials and commercialization. Introducing new therapies is a costly and complex process, one that can be difficult for smaller companies to fund without the external capital of Big Pharma.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Principal Technologies is a client of the Investing News Network. This article is not paid-for content.

Additional information on investing in life science stocks — FREE


Biotech Market Update: Q1 2024 in Review

What biotech trends shaped the market in the first quarter of 2024? Experts weigh in on what happened and what's to come.

The first quarter of 2024 brought a surge of initial public offerings (IPOs) and M&A activity within the biotech industry, signaling continued interest from investors who are keen to get exposure to the life science sector.

Punctuating the period, AstraZeneca (LSE:AZN,NASDAQ:AZN) announced plans in March to acquire its longtime partner Fusion Pharmaceuticals, as well as startup Amolyt, which is focused on rare endocrine diseases. At the time of this writing, 14 biotech deals had been struck in 2024, according to data from Biopharma Dive.

Meanwhile, data from investment bank Jefferies shows that biotech companies raised nearly $10 billion in follow-on stock offerings in January and February, putting them on track for their highest quarterly total in three years.

Against that backdrop, two influential factors continued to shape the biotech landscape in Q1: patent cliffs and the implementation of the Inflation Reduction Act (IRA). Read on for an overview of those and other key trends.


Pharma giants chase biotech deals

With patent cliffs looming, leaders in the pharma industry have strategically turned to biotech partnerships and investments. A prime example is Johnson & Johnson (NYSE:JNJ) and Novo Holdings' recent participation in a Series A funding round for Swedish biotech startup Asgard Therapeutics. The developer of in vivo treatments represents an opportunity for established pharma companies to support innovation and explore new therapeutic avenues.

“Pharma companies have now been (put) to work,” said Maha Katabi, general partner at Sofinnova Investments, during a panel at January's Biotech Showcase event. “There is a great need to replenish (the) innovation pipeline. There's plenty of innovation in our sector, especially in the hands of biotech companies, and once proof of concept is achieved, that becomes a very rarefied but unique class that pharma is very interested in talking to.”

Other pharma companies have also pursued acquisitions and partnerships to strengthen their market positions. In Q1, AbbVie (NYSE:ABBV) agreed to acquire immune drug developer Landos for US$138 million, enhancing its presence in the immunology sector. Additionally, Pfizer's (NYSE:PFE) completed US$43 billion acquisition of Seagen in December 2023 prompted it to focus on four types of cancer, with plans to have eight new drugs on the market by 2030.

Ahead of the 2028 patent expiration of its top-selling cancer drug Keytruda, Merck (NYSE:MRK) made progress in refilling its drug pipeline by announcing plans to acquire cancer biotech company Harpoon Therapeutics for US$680 million in January, and by obtaining approval for Winrevair, a lung disease drug acquired through its 2021 buyout of Acceleron Pharma. Merck expects that Winrevair will create US$35 billion in sales by 2035. The company also announced its intention to develop newer versions of its HPV vaccines, Gardasil and Gardasil 9, in March.

In light of these strategic moves, it’s worth noting the progress made by biosimilar developers in offering more affordable alternatives to expensive biologic drugs. Simlandi, a biosimilar to AbbVie’s Humira developed by Alvotech (NASDAQ:ALVO) and Teva Pharmaceuticals (NYSE:TEVA), won US Food and Drug Administration (FDA) approval in February following initial rejections due to manufacturing issues. Simlandi has become the first biosimilar to be designated as interchangeable with Humira, whose patent expired in January 2023.


Pharma and biotech companies react to IRA policies

The Centers for Medicare & Medicaid Services confirmed on January 3 that sickle cell disease would be the initial focus of a pilot program designed to improve patient access to costly cell and gene therapies.

Elsewhere, implementation of drug price negotiations under the IRA had a significant impact on the pharma and biotech industries, with several lawsuits filed by Big Pharma against the US Department of Health and Human Services alleging that drug price provisions violate due process. AstraZeneca went as far as to argue that Medicaid’s authority under the IRA is unconstitutional, a claim that was ultimately dismissed by the US District Court in Delaware.

Initial offers for 10 drugs — including Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica and Stelara, as well as insulins Fiasp and NovoLog — were sent to manufacturers on February 1. Administration officials said they expect these negotiations to extend into the summer, with final prices being determined by September 1.

Pfizer has stated that concerns over the IRA are the main reason for the company’s shift to developing biologics, which are safe from price negotiations for 13 years, instead of small-molecule drugs, which only have a nine year window.

Although experts like Peter Rubin, executive director of No Patient Left Behind, are concerned that these provisions could have negative effects on research and development into new small-molecule drugs, companies such as Madrigal Pharmaceuticals (NASDAQ:MDGL) demonstrated continued potential for innovation in this area in Q1. Madrigal's groundbreaking FDA approval for its MASH treatment and subsequent public offering of its common stock highlight the opportunities that still exist within the small-molecule drug landscape.

Aside from that, in February, AstraZeneca received FDA approval for Tagrisso, a small-molecule drug to be administered alongside chemotherapy in lung cancer patients.


CAR-T therapies, ADCs and weight-loss drugs in focus

The field of CAR-T therapy, a promising area of cancer immunotherapy that a report from Evaluate calls “the hottest real estate in oncology,” has garnered significant interest from investors and regulators in recent years.

In January, Johnson & Johnson secured regulatory backing from the European Medicines Agency for earlier use of its CAR-T treatment Carvykti in treating multiple myeloma. The company also in February announced promising findings from a late-stage study on Nipocalimab, an investigational monoclonal antibody.

According to BioInformant, companies working on CAR-T therapies have attracted a total of US$6.7 billion in venture capital investment and raised US$5.76 billion through their IPOs over the past decade.

Looking forward to the future, EY Global Life Sciences Deals Leader Subin Baral told Pharmaceutical Technology in December of last year that CAR-T therapies likely hold the most investment potential within personalized medicine, although he clarified that the biggest investment surge is likely a few years away, indicating the potential for long-term growth. Recently, researchers have identified use cases for CAR-T therapy to treat lupus.

Despite this promise, 25 recent reports of rare blood cancers in patients who received CAR-T therapy prompted the FDA to order drugmakers to add warnings to their packaging. Nevertheless, FDA spokesperson Carly Kempler told NBC News that “the overall benefits of these products continue to outweigh their potential risks.”

Subin expects more exploration of other therapies in the short term, such as antibody-drug conjugates (ADCs). ADCs feature an antibody linked to a cytotoxic payload, which is released when the ADC binds to its target.

Several pharma companies also focused on the weight loss drug market in 2024's first quarter. For example, Roche Holding (OTCQX:RHHBF,SWX:ROG) discontinued eight drug candidates to concentrate on obesity treatments, and Viking Therapeutics (NASDAQ:VKTX), a small biotech firm, saw its share price double after reporting promising results in mid-stage trials for its obesity drug VK2735. For its part, Danish company Zealand Pharma (CPH:ZEAL) reported positive results in February for survodutide, which could be a potential obesity treatment.

Novo Holdings announced plans to purchase global contract development and manufacturing organization Catalent (NYSE:CTLT) for US$16.5 billion in February, an acquisition that will enable increased production of its blockbuster drugs Ozempic and Wegovy by taking over operations at three plants in Italy. In a significant development, Medicare said in March that it will cover Wegovy under Part D plans for select patients with a history of heart disease.

Also in March, Novo Nordisk (NYSE:NVO), which is owned by Novo Holdings, shared promising results from a study of its latest obesity treatment, amycretin. The biologic drug demonstrated an average weight loss of 13.1 percent in 12 weeks, surpassing Wegovy’s 6 percent average. Similarly, Eli Lilly’s (NYSE:LLY) biologic diabetes drug Mounjaro generated over US$5 billion in sales in 2023, driving a 20 percent revenue increase compared to 2022. The strong financial performance of both companies has led analysts to predict they could become healthcare’s first trillion-dollar firms.


Biotech research trends to watch in 2024

Looking ahead to Q2, Brian Buntz, pharma and biotech editor at WTWH Media, anticipates increased stability in the biotech sector, citing a time-series analysis of the NASDAQ Biotech Index (INDEXNASDAQ:NBI).

In addition, several crucial FDA approvals are anticipated between April and June that may affect the pharma and biotech landscapes. These include potential expanded approvals for CAR-T therapies and Pfizer’s gene therapy for hemophilia B. Alnylam Pharmaceuticals (NASDAQ:ALNY), on the other hand, has encountered challenges as the data readout for its heart disease drug HELIOS-B was pushed to June or July, raising concerns about the drug’s efficacy.

In the field of neurological disorders, some promising developments emerged during Q1, and will potentially influence market trends in the healthcare industry. Recent research has revealed that focused ultrasounds could enhance the plaque-clearing effects of Aduhelm, an anti-amyloid-beta monoclonal antibody drug developed by Biogen (NASDAQ:BIIB) and Eisai (TSE:4523) that has shown difficulty penetrating the blood-brain barrier. This discovery may lead to more effective treatment options for patients with Alzheimer’s disease and other neurological conditions.

Various promising drugs for schizophrenia are currently in different stages of development. Karuna Therapeutics' KarXT, designed to minimize side effects while maximizing therapeutic effects by targeting a different brain chemical than traditional treatments, is expected to receive an FDA decision in September. Other contenders in the race for FDA approval include Cerevel Therapeutics Holdings (NASDAQ:CERE), which AbbVie plans to acquire by mid-2024, and Nuplazid by Acadia Pharmaceuticals (NASDAQ:ACAD), which is already approved for psychosis in Parkinson’s disease.

Finally, Novo Nordisk in March announced its intention to purchase RNA drug developer Cardior, along with its mid-stage treatment CDR132L. Results from that trial are expected in September and could influence the company’s market position and the broad landscape of RNA-based therapeutics.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

Additional information on investing in life science stocks — FREE

Top 5 NASDAQ Biotech Stocks of 2023

With 2023 coming to a close, that means it’s time to look back at the top NASDAQ biotech stocks of the year.

The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) has slowly tracked downward over the course of 2023 in response to the high levels of volatility seen across global markets.

Starting out the year at 4,174.3, the index was at 3,998.54 as of December 6, 2023. But while the current economic environment means the biotech sector may have a complex road ahead, robust growth could be in store in the future.

According to a recent report from Grand View Research, the global biotech market is expected to grow at a compound annual growth rate of 13.96 percent from now to 2030, reaching a valuation of US$3.88 trillion.

Driving that growth will be favorable government policies, investment in the sector, increased demand for synthetic biology and a rise in chronic disorders such as cancer, heart disease and hypertension.

Despite current challenges, the top NASDAQ biotech stocks have seen sizeable share price increases this past year, and the top gainers are outlined below. Data was gathered on December 5, 2023, using TradingView’s stock screener, and all NASDAQ biotech stocks had market caps between US$50 million and US$500 million at that time.


1. TScan Therapeutics (NASDAQ:TCRX)

Company Profile

Year-to-date gain: 321.76 percent; market cap: US$296.13 million; share price: US$6.80

TScan Therapeutics is developing T-cell receptor-engineered therapies (TCR-T) for the treatment of patients with cancer. Its lead TCR-T therapy candidates are TSC-100 and TSC-101, which are intended for patients with hematologic malignancies. Multiplexed TCR-T therapy candidates for the treatment of various solid tumors are also in TScan’s development pipeline.

In May, TScan and biopharma giant Amgen (NASDAQ:AMGN) announced a multi-year collaboration agreement under which they will use TScan's proprietary target discovery platform, TargetScan, to identify the antigens recognized by T-cells in patients with Crohn’s disease. At various points this past year, the clinical-stage biotech company also announced US Food and Drug Administration (FDA) clearance for five investigational new drug (IND) applications: T-Plex, TSC-204-A0201 and TSC-204-C0702 for solid tumors; TSC-200-A0201, which is targeting HPV16 to treat solid tumors; and TSC-203-A0201, which is geared at PRAME, or preferentially expressed antigen in melanoma.

Before the year is out, the company plans to complete two more IND applications and report interim clinical data for its TSC-100 and TSC-101 program. TScan's share price reached its highest point in 2023 on November 30, hitting US$7.15.


2. Immunome (NASDAQ:IMNM)

Company Profile

Year-to-date gain: 229.17 percent; market cap: US$338.42 million; share price: US$7.92

Immunome has a proprietary platform for identifying novel therapeutic antibodies and their targets by leveraging components of the immune system — known as human memory B cells — from patients who have learned to fight off their disease. The company has a collaboration agreement with AbbVie (NYSE:ABBV) to identify up to 10 novel target-antibody pairs using Immunome’s proprietary Discovery Engine human memory B cell technology platform.

In October, Immunome completed a merger with Morphimmune, a private biotech firm developing targeted oncology therapeutics, along with a US$125 million private placement with leading institutional investors.

“This merger is an essential step in establishing a preeminent oncology company,” said Dr. Clay B. Siegall, Immunome's chairman and CEO. “We believe that we are well positioned to advance our current oncology pipeline into the clinic, build upon the pipeline through our technology platform and proprietary toolbox, and expand our portfolio through strategic transactions focused on clinical and preclinical assets.”

This NASDAQ biotech stock hit a yearly high of US$9.52 on October 17.


2. Immunome (NASDAQ:IMNM)

Company Profile

Year-to-date gain: 229.17 percent; market cap: US$338.42 million; share price: US$7.92

Immunome has a proprietary platform for identifying novel therapeutic antibodies and their targets by leveraging components of the immune system — known as human memory B cells — from patients who have learned to fight off their disease. The company has a collaboration agreement with AbbVie (NYSE:ABBV) to identify up to 10 novel target-antibody pairs using Immunome’s proprietary Discovery Engine human memory B cell technology platform.

In October, Immunome completed a merger with Morphimmune, a private biotech firm developing targeted oncology therapeutics, along with a US$125 million private placement with leading institutional investors.

“This merger is an essential step in establishing a preeminent oncology company,” said Dr. Clay B. Siegall, Immunome's chairman and CEO. “We believe that we are well positioned to advance our current oncology pipeline into the clinic, build upon the pipeline through our technology platform and proprietary toolbox, and expand our portfolio through strategic transactions focused on clinical and preclinical assets.”

This NASDAQ biotech stock hit a yearly high of US$9.52 on October 17.


4. Immix Biopharma (NASDAQ:IMMX)

Company Profile

Year-to-date gain: 118.77 percent; market cap: US$100.33 million; share price: US$5.05

Immix Biopharma is developing personalized therapies for oncology and immunology. The lead cell therapy in its pipeline is CAR-T NXC-201 for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma. Currently in an ongoing Phase 1b/2a clinical trial, NXC-201 has an orphan drug designation from the FDA for both these indications.

In late November, the clinical-stage biotech company announced FDA clearance for its IND application for NXC-201; this will allow for expanded studies of NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

“Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, CEO of Immix Biopharma. “No approved treatment options currently exist for relapsed/refractory AL Amyloidosis patients.”

Immix Biopharma's share price reached a 2023 high of US$5.47 on November 28.


5. Standard BioTools (NASDAQ:LAB)

Company Profile

Year-to-date gain: 109.83 percent; market cap: US$204.58 million; share price: US$2.46

Last on this NASDAQ biotech stocks list is Standard BioTools, a leading supplier of biomedical research technologies, including its proprietary mass cytometry and microfluidics technologies. The company's clients represent a variety of sectors, including academia, government, pharma, biotech, plant and animal research and clinical laboratories.

Standard BioTools is set to soon complete a strategic all-stock merger with proteomics technology firm SomaLogic (NASDAQ:SLGC), a leader in data-driven proteomics technology. In its third quarter financials, Standard BioTools reported instrument sales growth of 47 percent year-to-date and 14 percent over the previous quarter, with total revenue increasing by 10 percent year-to-date despite a 1 percent decline for the quarter.

Shares of Standard BioTools traded at a 2023 peak of US$3.16 on September 1.


Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE


Top 3 Canadian Biotech Stocks of 2024

Which Canadian biotech stocks have performed the best over the last 12 months? Here’s a look at the top three by year-on-year share price gains.

Biotech is a dynamic industry that is driving scientific advancements and innovation in healthcare.

According to Grandview Research, the global biotech market was worth US$1.55 trillion in 2023, and the firm expects it to grow at a CAGR of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.

In Canada, the biotech sector is home to companies pursuing cutting-edge therapies and medical technologies, and the Investing News Network has identified the top three biotech stocks based on their year-on-year gains.

Data was collected on April 16, 2024, using TradingView's stock screener and companies listed had market capitalizations of over C$50 million at that time. Companies on the TSX, TSXV and CSE were considered, but no TSXV-listed stocks made the list this time. Read on to learn what's been driving these biotech firms.


1. ME Therapeutics Holdings (CSE:METX)

Company Profile

Year-on-year gain: 7,240 percent; market cap: C$86.23 million; current share price:C$3.67

ME Therapeutics Holdings is a biotechnology company developing cancer-fighting drug candidates that can increase the efficacy of current immuno-oncology drugs by targeting suppressive myeloid cells, which have been found to hinder the effectiveness of existing immuno-oncology treatments. Immuno-oncology is a relatively new area of cancer drug research, and has shown promising results when used to treat cancer with low survival rates.

In December 2023, ME Therapeutics announced that its most advanced preclinical asset, h1B11-12, an antibody targeting G-CSF, had been found to bind to and neutralize G-CSF in lab tests and animal studies. Subsequent studies conducted with Dr. Kenneth Harder’s laboratory at the University of British Columbia revealed that G-CSF is involved in many different processes influencing how breast and colon cancers grow and spread.

In a January update, ME Therapeutics shared that preliminary results for trials of h1B11-12 on non-human primates were tolerated well up to a dose of 10 milligrams per kilogram. The next step is to study how the drug behaves inside the body, which will help the company plan future research and decide how to continue developing h1B11-12.

ME Therapeutics saw a major share price boost on February 27, when it announced a non-brokered private placement to raise gross proceeds of up to C$1.55 million. It said it was unaware of any other change that would account for the rise.


2. Cardiol Therapeutics (TSX:CRDL)

Press ReleasesCompany Profile

Year-on-year gain: 230.14 percent; market cap: C$160.18 million; current share price: C$2.41

Cardiol Therapeutics is a biopharma company developing innovative treatments for inflammation and fibrosis in cardiovascular conditions. Its research is concentrated on pericarditis, which is inflammation of the membrane surrounding the heart; myocarditis, or inflammation of the heart muscle; and heart failure.

Cardiol currently has two drug candidates in its pipeline. CardiolRX, the company's lead candidate, is being clinically developed for use in rare heart diseases. Aside from those efforts, Cardiol is developing a drug formulation of cannabidiol, called CRD-38, for its efficacy in treating heart conditions subcutaneously.

The company's share price began a significant rise in mid-February, when the US Food and Drug Administration granted it orphan drug designation for CardiolRx. Less than a week later, Cardiol completed patient enrollment in a Phase II open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. It said it was expecting top-line results in the second quarter of this year.


3. Medicenna (TSX:MDNA)

Company Profile

Year-on-year gain: 130 percent; market cap: C$131.61 million; current share price: C$1.84

Medicenna is a clinical-stage immuno-oncology company specializing in the development of innovative therapies for patients with challenging unmet needs. Its focus is on creating novel, highly selective versions of cytokines, such as IL-2, IL-4, and IL-13, which it refers to as "Superkines" and "empowered superkines."

Cytokines are small proteins that play a crucial role in regulating immune responses and helping cells communicate. Interleukins, which Medicenna says are at the core of its therapies, are groups of cytokines. The company's interleukins are engineered to fuse with specific molecules to optimize their function.

Medicenna's mission is to leverage its expertise in cytokine biology to design life-changing therapies that can potentially transform people's lives. Its therapies treat solid tumors, which have a low response rate to conventional cancer treatments, and autoimmune and neuroinflammatory diseases.

In February, the company shared the news that its lead candidate, MDNA11, had been used in combination with Keytruda in a study testing the effectiveness of the two drugs in treating patients with advanced solid tumors.


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Pharma Market Forecast: Top Trends That Will Affect Pharma in 2024

As 2024 begins, pharmaceutical industry experts are looking to see how AI, M&A and other trends will shape the market in the new year.

The pharmaceutical industry is a dynamic and complex sector that plays a vital role in healthcare.

While there are many factors at play, recently experts have been have been looking toward groundbreaking advances in areas like cell and gene therapies, as well as the increasing use of artificial intelligence (AI).

These trends have the potential to transform the way doctors treat disease and improve patient outcomes, but they come with challenges and risks to consider as well. Read on for a look at how these technologies could impact the pharmaceutical industry, plus key factors investors should be aware of when evaluating opportunities in this space


AI driving advances in drug discovery and development

The rapid uptake in AI technology in 2023 was felt across many industries, including the healthcare sector. Market participants believe the use of AI in drug discovery and development will accelerate the process of identifying new drug candidates, reduce the hefty cost of drug development and improve the success rate of drug trials.

AI has also proven to be a potential game changer in the field of data analytics. By applying machine-learning algorithms, researchers can gain useful insights into disease mechanics and identify potential drug targets.

Furthermore, AI may be able to help the healthcare sector meet growing demand for personalized medicine and precision therapies by analyzing patient responses to treatments. According to projections from Allied Market Research, the global personalized medicine market will increase at a compound annual growth rate of 11.2 percent between 2022 and 2031, reaching a valuation of US$869.5 billion by the end of the forecast period.

A PWC report affirms the idea that AI and analytics will be significant drivers of growth in the pharmaceutical sector in the coming year. The firm suggests that embracing AI and generative AI will allow companies to expedite drug delivery to the market while saving at least 30 percent on operational costs thanks to automation and high-quality data.

Analysts for Allied Market Research have identified oncology as a large segment of the personalized medicine industry. And based on IQVIA's Global Use of Medicines 2023 Outlook to 2027 report, demand for innovative drugs for cancer treatment is expected to rise during the forecast period. Oncology is the largest therapeutic market for drugs, and companies are set to double their spending on these medicines to around US$370 billion during that time.

IQVIA also highlights several other therapeutic areas that are expected to drive growth in healthcare spending. Spending on treatments for autoimmune disorders is projected to reach US$177 billion globally by 2027; meanwhile, the neurology sector is seeing increased investment in migraine therapies and research into potential cures or treatments for rare neurological diseases, as well as for more common conditions like Parkinson’s and Alzheimer’s.

Despite the growth potential of new treatments, the pharmaceutical sector will have some challenges to address. In its World Preview 2022 Outlook to 2028, Evaluate Pharma points to the growing number of patents that are set to expire in the next 10 years. Although that's likely to create new opportunities for generics and biosimilar products, the original creators will need to seek new forms of revenue. It's possible that pharmaceutical companies will turn to AI to help identify new drug targets and optimize the development process in order to maintain or establish a competitive edge.


Pharmaceutical industry M&A to stay steady in 2024

As the home of many leading pharmaceutical companies and a major center for research and development, the US plays a significant role in the pharmaceutical sector, and it's important to hone in on trends in the country.

In 2024, as states continue to redetermine eligibility for Medicaid and disenroll those who no longer qualify, pharmaceutical companies are bracing for anticipated changes in spending, which will likely impact their revenue and pricing strategies. On that note, a report by the Kaiser Family Foundation highlights a potential decrease in prescription drug spending in the US due to the loss of Medicaid coverage for individuals.

On a different note, M&A activity will continue to shape the pharmaceutical industry in 2024, according to PWC’s Pharmaceutical and Life Sciences: US Deals 2024 Outlook report.

The authors project that M&A activity in the pharmaceutical and life science markets will remain steady in 2024, with deal values and volumes similar to those seen in 2023. They expect that the total value of M&A transactions across all subsectors of those industries to total roughly US$225 billion to US$275 billion this coming year. Regulatory challenges and fierce competition for assets will continue to be a factor in drafting M&A deals, and PwC suggests that companies adopt a strategic approach that combines internal innovation with external acquisition.

For his part, EY’s Subin Baral suggests in an article that life science businesses with a strategic focus on therapeutic areas where they can add value will be poised for success in the coming year.


Investor takeaway

The pharmaceutical industry is set to face both opportunities and hurdles in the coming year as growth in certain therapeutic areas is tempered by the impact of changing regulatory and market dynamics.

However, companies have the potential to mitigate challenges and continue to drive innovation by embracing AI-driven solutions and leveraging technology to optimize their drug-discovery and development processes. Furthermore, companies that can adopt M&A strategies that focus on profitability and growth in an increasingly competitive environment will be well positioned to build on pharmacology’s legacy of success.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Pure Life Healthcare Management is a client of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Top 5 NASDAQ Pharma Stocks of 2023

2023 is at an end, which means it’s time to reflect on the top-performing NASDAQ pharma stocks year-to-date.

2023 presented challenges for the pharmaceutical market, including rising inflation, government-led drug price cap negotiations and waning demand for COVID-19 vaccines. However, the industry's major underlying drivers — such as higher rates of cancer and chronic diseases — are still driving innovation in this sector.

The US reigns supreme in the pharma market, both in terms of drug demand and development. As of December 14, 2023, 53 novel medicines had been approved by the US Food and Drug Administration (FDA) for the year, compared to 37 such approvals for all of 2022. Big Pharma largely stole the show throughout the course of the year, but a number of small- and mid-cap NASDAQ pharma stocks also made gains in 2023.

Below the Investing News Network profiles 2023’s five top NASDAQ pharma stocks by share price performance. Data was compiled on December 5, 2023, using TradingView’s stock screener, and all companies listed had market caps between US$40 million and US$500 million at that time. Read on to learn more about their activities this past year.


1. Minerva Neurosciences (NASDAQ:NERV)

Company Profile

Market cap: US$43.29 million; year-to-date gain: 286.88 percent; current share price: US$6.19

First up on this top-performing NASDAQ pharma stocks list is Minerva Neurosciences, a clinical-stage company that is developing therapeutic candidates geared at treating central nervous system diseases. The company's portfolio includes roluperidone for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease.

Minerva's share price spiked in mid-July to a year-to-date of high of US$13.22 following the completion of a US$20 million equity financing that improved its cash position. As of December 5, the company's share price had fallen off that high by about 50 percent, but it was still up more than 286 percent from the start of 2023.


2. Inozyme Pharma (NASDAQ:INZY)

Company Profile

Market cap: US$240.87 million; year-to-date gain: 235.04 percent; current share price: US$3.90

Clinical-stage Inozyme Pharma is developing novel therapeutics for the treatment of rare diseases impacting the vasculature, soft tissue and skeleton. Its product pipeline inclues INZ-701, an enzyme replacement therapy.

INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 deficiency associated with Generalized Arterial Calcification of Infancy, as well as ABCC6 deficiency, which causes progressive calcification in the eyes, skin and arteries. Positive preliminary data released in April, alongside strong first quarter financials shared in May, helped Inozyme's share price rally from the beginning of April to reach a year-to-date high of US$7.33 on July 21.


3. CASI Pharmaceuticals (NASDAQ:CASI)

Company Profile

Market cap: US$78.34 million; year-to-date gain: 235.23 percent; current share price: US$5.88

CASI Pharmaceuticals is acquiring, developing and commercializing pharmaceutical products and therapeutics with a focus on hematology oncology, as well as other areas of unmet medical need. Through its wholly owned subsidiary, CASI Pharmaceuticals (China), the company is working to launch medicines in the Chinese market.

After trading flat through much of the year, CASI's share price reached a year-to-date high on December 12, hitting US$8.48. This rise followed the November announcement of a major milestone — CASI's partner Juventas Cell Therapy received market approval from the China National Medical Products Administration for its investigational cell therapy, CNCT 19 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia.


4. Applied Therapeutics (NASDAQ:APLT)

Company Profile

Market cap: US$193.07 million; year-to-date gain: 221.83 percent; current share price: US$2.41

Applied Therapeutics is developing a pipeline of novel drug candidates in areas of high unmet medical need. The company’s lead drug candidate is govorestat, a novel central nervous system penetrant aldose reductase inhibitor for the treatment of central nervous system rare metabolic diseases, including galactosemia, sorbitol dehydrogenase (SORD) deficiency and PMM2-CDG. Its pipeline also includes treatments for diabetic cardiomyopathy and diabetic retinopathy.

Applied Therapeutics reached a number of milestones this year, and they steadily pushed its share price from US$0.70 at the start of the year to a year-to-date high of US$3.42 on December 12.

In late April, the company presented results from its ACTION-Galactosemia Kids study of govorestat, saying that it "demonstrated compelling evidence of clinical benefit alongside a favorable safety profile." Applied Therapeutics also announced plans to request a pre-new drug application (NDA) meeting with the FDA, and to submit a marketing authorization application (MAA) to the European Medicines Agency (EMA). Soon after, Applied Therapeutics strengthened its balance sheet with a US$30 million private equity financing.

In May, Applied Therapeutics' govorestat was granted orphan medicinal product designation by the EMA for treatment of SORD deficiency. The company announced in November that was on track to submit an NDA to the FDA and an MAA to the EMA for govorestat for the treatment of classic falactosemia in Q4 2023.


5. Aquestive Therapeutics (NASDAQ:AQST)

Company Profile

Market cap: US$158.91 million; year-to-date gain: 167.6 percent; current share price: US$2.39

Last on this list of the year's top-performing NASDAQ pharma stocks is Aquestive Therapeutics, which is developing orally administered products as non-invasive alternatives to current standard therapies.

Aquestive's portfolio includes: five commercialized products manufactured by the company and marketed by its licensees in the US and around the world; late-stage proprietary products focused on treating diseases of the central nervous system; and earlier-stage products for the treatment of severe allergic reactions, including anaphylaxis.

Aquestive's share price has experienced volatility in 2023, rising from a low of US$0.72 in mid-March to a year-to-date high of US$2.69 on May 23. In late March, Aquestive expanded its license and supply agreement with Pharmanovia for Libervant (diazepam) buccal film to additional global markets. In late May, the company reported positive results from its latest clinical studies evaluating the pharmacokinetic and pharmacodynamic performance of Anaphylm (epinephrine) sublingual film.

In other positive news, Aquestive received FDA acceptance of its NDA for Libervant (diazepam) buccal film for the treatment of seizure clusters in patients between two and five years of age.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE


Top 3 Canadian Pharma Stocks of 2024

Canada’s pharma industry is a key contributor to the global pharma market. Here are the top Canadian pharma stocks by share price performance over the past year.

From established players to up-and-coming firms, Canada's pharmaceutical landscape is diverse and dynamic.

In Q1, market watchers kept a close eye on pharma companies vying for the next major innovation.

Here the Investing News Network lists the top Canadian pharma stocks on the TSX and TSXV by year-on-year gains. All data was compiled on April 16, 2024, using TradingView’s stock screener, and the companies considered had market caps above C$100 million at that time. Read on to learn about what's been driving their share prices.


1. Cipher Pharmaceuticals (TSX:CPH)

Company Profile

Year-on-year gain: 161.29 percent; market cap: C$223.89 million; current share price: C$8.91

Cipher Pharmaceuticals is a specialty pharma company with a diverse portfolio of treatments, including a range of dermatology and acute hospital care products. The company has out-licensed some of its offerings as well.

In addition to its current portfolio, Cipher has acquired the Canadian rights to two new dermatology treatments currently undergoing Phase III clinical trials: MOB-015 for the treatment of nail fungus, and CF-101 for the management of moderate to severe plaque psoriasis. A Phase III COMFORT study of CF-101 has been completed, with a pivotal Phase III study due to start in early 2024; results are expected by 2026. MOB-015 trial results are expected in January 2025. The company is also conducting proof-of-concept studies on DTR-001, a topical treatment for removing tattoos.

On March 14, the company released its 2023 financial and operating results, showing a 2.5 percent increase in gross profit compared to the previous year and EBITDA of US$12 million, consistent with 2022.

Cipher began trading on the OTCQX Best Market under the symbol CPHRF on January 29.


2. Bausch Health Companies (TSX:BHC)

Company Profile

Year-on-year gain: 20.22 percent; market cap: C$4.34 billion; current share price: C$12.07

Bausch Health Companies, formerly Valeant Pharmaceuticals International, is one of the largest pharma companies in Canada. Its headquarters are in Laval, Quebéc, where the company has research and laboratory facilities equipped with state-of-the-art equipment and technology that play a crucial role in driving its research and development efforts.

Its range of offerings includes treatment options for gastrointestinal, neurological and dermatological conditions, as well as products for vision care and dentistry. In March, the company and its gastroenterology business, Salix Pharmaceuticals, announced that the two would be jointly supporting a Phase II study of Relistor, an opioid antagonist, in oral cavity squamous cell carcinoma. Bausch serves the Canadian and US markets, as well as a number of regions in Europe, the Middle East, Africa, the Caribbean, Latin America and the Asia Pacific region.

On April 3, the company announced that Uceris, an aerosol foam used to treat distal ulcerative colitis, would be available to patients in Ontario, Quebéc, Saskatchewan, New Brunswick and Nova Scotia through the provinces' public drug plans. Its acne vulgaris treatment PrARAZLO recently became available to patients through the BC PharmaCare public drug plan. Bausch's first quarter results are expected on May 2.


3. Biosyent (TSXV:RX)

Company Profile

Year-on-year gain: 11.91 percent; market cap: C$102.14 million; current share price: C$8.55

BioSyent is a specialty pharma company focused on improving patients' lives by licensing and acquiring innovative pharma products that are proven to be safe and effective with a track record of improving patient outcomes.

The company's subsidiary, known as BioSyent Pharma, offers a diverse range of healthcare products, including over-the-counter, behind-the-counter and prescription options.

On April 3, the annual Survey on OTC Counselling and Recommendations named FeraMAX, the company’s pediatric-friendly iron supplement, Canada's best oral iron supplement for the ninth consecutive year.

A couple of weeks later, on April 15, BioSyent Pharma extended its agreement with its European partner, allowing the BioSyent subsidiary to continue selling RepaGyn and Proktis-M in Canada until 2032.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.

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How to Invest in Medical Devices

What is the best way to invest in medical devices? The sector can be intimidating, but for interested investors it’s worth looking into.

The medical device market offers investors unique exposure to the overall life science space, especially in an era of fast-growing tech advancements in healthcare.

This industry covers a wide range of health and medical instruments used in the treatment, mitigation, diagnosis and prevention of diseases and physical conditions, and it continues to develop rapidly.

Examples of medical devices include neurostimulation devices, surgical implants, ultrasound imaging devices and robotic medical technology, along with insulin pumps and insulin pens for diabetes. Just as pharmaceutical companies seek to serve unmet needs, medical device companies do the same via innovative technologies.

Here the Investing News Network breaks down how to invest in medical devices and looks at what’s in store for the sector.


How to invest in medical device stocks?

Before investing in medical device stocks, it helps to understand their goals. Medtech companies will often seek to show investors that their products are ready to enter the market and will be in demand right away — whether it be by serving a large demographic or by targeting a specific ailment in the population that has an unmet medical need.

Like firms pursuing drug approvals, medtech companies must conduct clinical trials to bring their products to market; they have to refine their technology and confirm efficacy and safety to get regulatory approvals.

Successfully completed clinical trials and product approvals are usually major catalysts for a company’s share price. A medical device stock can experience a large jump when announcing positive results from a recent trial or approval from a regulatory body such as Health Canada, the US Food and Drug Administration or an equivalent agency in Europe or Asia. On the other hand, poor results can have a negative impact.

Patentability also plays a big role in a medical device company’s value. Once a product has been patented, the company controls its every move and can choose to license it or make other deals to expand device reach.

The sector is dominated by a handful of big medical device manufacturers, such as Thermo Fisher Scientific (NYSE:TMO), Abbott Laboratories (NYSE:ABT), Stryker (NYSE:SYK) and Medtronic (NYSE:MDT). That means investors interested in large-cap companies will have no trouble finding what they’re looking for.

Investors will also find smaller-cap companies amid the heavyweights — it’s just a matter of risk tolerance. Some medical device companies in the micro-cap range are Theralase Technologies (TSXV:TLT,OTCQB:TLTFF), Izotropic (CSE:IZO,OTCQB:IZOZF), Aurora Spine (TSXV:ASG,OTCQB:ASAPF) and Fonar (NASDAQ:FONR).


How to invest in medical device ETFs?

For those who prefer to mitigate risk, exchange-traded funds (ETFs) are a safer way to put money into the market. With exposure to various companies, any potential decrease in one stock won’t significantly drive down overall ETF returns. ETFs hold assets such as stocks, commodities and bonds, and trade close to their net asset value.

Typically ETFs track an index. In the medical device arena, there are two indexes that can be followed: the S&P Health Care Equipment Select Industry Index (INDEXSP:SPSIHE) and the Dow Jones US Select Medical Equipment Index (INDEXDJX:DJSMDQ).

The largest ETF in the medical device sector is the iShares US Medical Device ETF (ARCA:IHI), which has a focus on US companies that manufacture and distribute medical devices. This passive ETF tracks the Dow Jones US Select Medical Equipment Index. There are 69 holdings in the ETF; the five biggest in its portfolio are Thermo Fisher Scientific, Abbott Laboratories, Medtronic, Intuitive Surgical (NYSE:ISRG) and Stryker (NYSE:SYK).

The other ETF for investor consideration is the SPDR S&P Health Care Equipment ETF (ARCA:XHE).

It tracks the S&P Health Care Equipment Select Industry Index, and out of its 80 holdings, the top companies are Shockwave Medical (NASDAQ:SWAV), FIGS (NYSE:FIGS), Heska (NASDAQ:HSKA), Omnicell (NASDAQ:OMCL) and Lantheus Holdings (NASDAQ:LNTH).


What is the outlook for the medical device market?

According to Precedence Research, the global medical device market is projected to grow at a compound annual growth rate (CAGR) of 5.5 percent between 2022 and 2030 to reach US$850 billion.

A report from BCC Research is even more optimistic, estimating that the medical technology industry will cross revenue of almost US$953.4 billion by 2027, growing at a CAGR of 7.1 from 2022 to 2027.

Driving that growth will be an increase in diseases, particularly cancer and diabetes, plus cardiovascular, neurological, orthopedic and respiratory diseases, which are on the rise due to an aging population.

Chronic diseases are also growing in prevalence. The United Nations has said that by the end of 2050, the ratio of deaths per year due to chronic diseases is expected to rise to around 86 percent of total deaths, representing a 90 percent increase since 2019.

In short, with the future growth of the market anticipated to be in the billions, there are many opportunities for investing in the medical device industry.

This is an updated version of an article originally published by the Investing News Network in 2017.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE


Top 5 NASDAQ Medical Device Stocks of 2023

With the year almost over, here the Investing News Network profiles the top five NASDAQ medical device stocks of 2023.

The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2023 alone, 40 new devices were approved by the US Food and Drug Administration (FDA).

Wearable medical devices and the use of artificial intelligence in medical technology are two key trends in this sector. Moving forward, Fortune Business Insights projects that the global medical device industry will increase from US$536.12 billion in 2023 to US$799.67 billion by 2030, expanding at a CAGR of 5.9 percent.

Investors who want exposure to this wave of growth may want to consider NASDAQ medical device stocks. With 2023 nearing its end, here's a look back at the top-performing NASDAQ medical device companies year-to-date.

All data was compiled on December 21, 2023, using TradingView’s stock screener, and the medical device makers listed below had market caps between US$50 million and US$500 million at that time..


1. NeuroPace (NASDAQ:NPCE)

Company Profile

Year-to-date gain: 540.43 percent; market cap: US$232.35million; current share price: US$8.84

The first top NASDAQ medical device stock on this list is commercial-stage NeuroPace. The company's RNS System is the first and only commercially available, brain-responsive platform for the treatment of drug-resistant epileptic seizures. The platform also has the potential to treat patients with other brain disorders.

NeuroPace's share price saw forward momentum in the fourth quarter of this year, rising to a year-to-date high of US$10.30 on December 20. In October, the company announced the launch of a number of RNS System enhancements designed to improve outcomes by simplifying its use for both patients and clinicians. Soon after, NeuroPace released its Q3 financials, showing a 47 percent increase in revenues over the same period last year. As a result, the company increased its full-year revenue guidance to US$62.5 million to US$63.5 million, up from US$59 million to US$61 million.


2. Pulse Biosciences (NASDAQ:PLSE)

Company Profile

Year-to-date gain: 339.87 percent; market cap: US$670.21 million; current share price: US$12.18

Novel bioelectric medicine company Pulse Biosciences' proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology is designed to treat atrial fibrillation. The company believes there may also be other uses in cardiology for nsPFA.

Shares of Pulse dipped nearly 50 percent, reaching the US$4 level, in the third quarter of the year. However, Q4 brought a big boost to the stock, which reached US$13.05, its highest price for the year, on December 19. The company filed a premarket notification 510(k) to the FDA for its novel CellFX nsPFA percutaneous electrode in November. The following month, Pulse completed the first five procedures for the first-in-human feasibility study for its CellFX nsPFA cardiac catheter.


3. AVITA Medical (NASDAQ:RCEL)

Company Profile

Year-to-date gain: 88.88 percent; market cap: US$319 million; current share price: US$12.49

Next up on this list of the top NASDAQ medical device stocks is AVITA Medical, a regenerative medicine company developing and commercializing first-in-class devices and autologous cellular therapies for skin restoration.

AVITA has had a few FDA approvals for its products in 2023, including a premarket approval supplement for the use of its RECELL System to treat full-thickness skin defects, as well as a premarket approval for its RECELL System for the treatment of vitiligo. According to the company, RECELL for the repigmentation of stable, depigmented vitiligo lesions is the first FDA-approved therapeutic device that offers a one-time treatment at the point of care.

After starting 2023 at a low of US$6.32, AVITA's share price hit its highest point of the year at US$21.70 on July 17. In November, AVITA announced that its revenues for Q3 were up 51 percent over the same period in the previous year.


4. Accuray (NASDAQ:ARAY)

Company Profile

Year-to-date gain: 35.55 percent; market cap: US$277.63 million; current share price: US$2.86

Accuray develops and commercializes radiation therapy technology used in oncology and neuro-radiosurgery, with the potential for applications in additional indications. Its products include the CyberKnife and TomoTherapy platforms.

In June, the company announced its inclusion in the Russell 2000 Index, as well as the broad-market Russell 3000 Index. Later in the summer, Accuray received 510(k) clearance from the FDA for its VitalHold breast package on the Radixact System. The company's share price reached a year-to-date high of US$4.29 on July 31.

Later in the year, the Tomo C radiation therapy system was approved by the Chinese National Medical Products Administration, and the company initiated sales of the VitalHold package to support surface-guided radiation therapy on the Radixact System in Japan. Accuray recently reported financials for the first quarter of its 2024 fiscal year, highlighting net revenue of US$103.9 million, an increase of 7.7 percent over the same period in the previous year.


5. CVRx (NASDAQ:CVRX)

Company Profile

Year-to-date gain: 34.08 percent; market cap: US$516.02 million; current share price: US$24.98

Top NASDAQ medical device stock CVRx is the developer of the world’s first FDA-approved neuromodulation device to treat symptoms of heart failure. The company's proprietary novel baroreceptor neuromodulation therapies are designed to address imbalances of the autonomic nervous system that can lead to heart failure and other cardiovascular diseases.

In its Q3 financials, CVRx reported total revenues of US$10.5 million, an increase of 70 percent over the prior-year quarter. On December 14, CVRx saw its share price hit its highest point in 2023, rising to US$25.24.


Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE


How to Invest in Genetics

Genetics investing drives research that may ultimately prevent major illnesses, making it one of the most important life science fields.

Genetics is the study of genes, their variations and hereditary characteristics, as well as how these traits are passed on through generations. So what is genetics investing?

When it comes to genetics investing, companies in this niche of the life science sector are mostly focused on four areas: DNA sequencing, genetic testing, gene therapy and genomics, which includes genome editing.

Additionally, there are several major branches that make up the genetics tree: classical genetics, molecular genetics and evolutionary genetics. There are various other subcategories within those branches, all of which include genetics companies that market participants can invest in.

Here the Investing News Network provides a breakdown of each of these areas, looking at ways to invest in genetics and what could disrupt this ever-evolving market.


What are the key branches of the genetics sector?

Before diving into investment opportunities in the genetics market, it’s important to understand the industry and the four key areas mentioned above. They are defined as follows:

  • DNA sequencing: According to the National Human Genome Research Institute, DNA sequencing involves determining the order of the four “bases” that make up DNA molecules. These chemical building blocks are adenine, guanine, cytosine and thymine, and determining their sequence allows scientists to understand what type of genetic information a section of DNA holds.
  • Genetic testing: The US National Library of Medicine defines genetic testing as testing that pinpoints changes in chromosomes, genes and proteins in order to diagnose a genetic disorder. There are thousands of genetic tests available, such as molecular genetic tests, chromosomal genetic tests and biochemical genetic tests.
  • Gene therapy: Gene therapy is an approach that uses a person’s genes to treat or prevent diseases. There are several different types of gene therapy, such as replacing a mutated, disease-causing gene with a healthy version of the gene, getting rid of a mutated gene that isn’t working properly and even introducing a new gene into the body to fight off diseases.
  • Genomics: Genomics is the overarching study of all of a person’s genes. It includes how those genes interact both with one another and with a person’s environment. Genome editing purposefully alters the DNA sequencing of a living cell.

How big is the genetics market?

The DNA sequencing market is a rapidly growing industry. According to Precedence Research, the sector is projected to reach a whopping US$37.99 billion in value by 2032.

The firm states that the market for DNA sequencing is being driven by technological advances, the increasing prevalence of cancer and rising demand for precision medicine, as well as higher investment in research and development. DNA sequencing has become a vital component of this growth and has played a key role in remodeling molecular biology and genomics research.

“The fast development of DNA sequencing technology is providing scientists with the capability to generate information about genetic variation and outlines of gene expression on an unparalleled scale,” the report explains.

Genetic testing is another segment of the genetics industry that is growing at a fast pace. Unsurprisingly, technology has had a huge impact on genetic testing, and so has the fact that governments and regulatory bodies are turning their attention to this market in order to regulate and raise awareness.

A Global Market Insights report estimates that the genetic testing market will reach US$43 billion by 2032, fueled by an increase in the use of genetic testing for diseases such as cancer, cystic fibrosis and sickle cell anemia.

In the pharmaceutical sector, gene therapy is one of the more advanced treatment options, and gene therapy pipeline candidates are robust in late-stage clinical trials.

By 2030, Grandview Research estimates that the gene therapy market will be worth US$29.47 billion, growing at a compound annual growth rate (CAGR) of 19.1 percent from 2023 to 2030. The report attributes growth in this sector to increasing clinical trials for advanced cancer therapeutics to address the lack of effective treatments.

Finally, the global genomics market is seen reaching US$83.1 billion by 2028, achieving a CAGR of 12.4 percent from 2023 to 2028. As Markets and Markets notes, "the market is mainly driven by falling prices of sequencing technologies and initiatives by governments in various countries focusing on the use of genomics in personalized medicine."

Biotech and pharmaceutical companies are also expressing interest in this sector, which is expected to further fuel genomics’ growth in the coming years.


How to invest in genetics stocks and ETFs?

For those looking to dive into the genetics sector, there are a wide range of investment opportunities to consider. Investing in stocks is the most common route, but there are risks due to the market’s volatility, especially when it comes to wins or losses with the US Food and Drug Administration (FDA).

Exchange-traded funds (ETFs) are another popular option for gaining exposure to the industry, and come with less risk than investing in a single stock. Here’s a look at stocks and ETFs to consider.

Genetics investing: Stocks

There are a number of large-cap companies for those looking for genetics behemoths. The list includes major players like Amgen (NASDAQ:AMGN), Novo Nordisk (NYSE:NVO) and Regeneron Pharmaceuticals (NASDAQ:REGN).

When it comes to genetic testing, there are several key stock options, including Exact Sciences (NASDAQ:EXAS), Bio-Techne (NASDAQ:TECH) and Hologic (NASDAQ:HOLX).

Gene therapy stocks are also a popular choice for genetics investing. These include companies like Novartis (NYSE:NVS), Gilead Sciences (NASDAQ:GILD) and UniQure (NASDAQ:QURE).

Some options for genomic stocks have already been mentioned, but Sarepta Therapeutics (NASDAQ:SRPT) and Veracyte (NASDAQ:VCYT) are also companies to consider.

Genetics investing: ETFs

For those who would prefer to invest in the genetics industry overall rather than an individual stock, ETFs are the way to go. Examples of genetics ETFs on the market include:

  • Ark Genomic Revolution ETF (ARCA:ARKG): This ETF tracks firms focused on CRISPR technology, targeted therapeutics, bioinformatics, molecular diagnostics, stem cells and agricultural biology.
  • Global X Genomics & Biotechnology ETF (NASDAQ:GNOM): This ETF invests in stocks that are involved in genomic science, which includes gene editing, genomic sequencing, genetic medicine and therapy, computational genomics and biotechnology.
  • iShares Genomics Immunology and Healthcare ETF (ARCA:IDNA): The focus of this ETF is companies involved with genomics, immunology and bioengineering.

What's the outlook for the genetics industry?

In terms of what will — and already has — disrupted the genetics industry, CRISPR technology has been on the rise for quite some time. It uses short repeating DNA sequences with “spacers” dividing them to treat genetic diseases.

There are a range of clinical trials underway involving CRISPR technology. “It’s a whole new era of medicine," Daniel Anderson, a biomedical engineer at the Massachusetts Institute of Technology in Cambridge, remarked in mid-2021.

CRISPR technology may be in its early stages, but in the coming years it’s expected to have a big impact on how genetic diseases are treated. BCC Research reports that this segment was worth US$3.3 billion in 2022 and is expected to increase by a CAGR of 22.3 percent between 2022 and 2027 to reach US$9.2 billion.

As can be seen, the genetics industry is vast and complex, but is also ripe with investment opportunities.

This is an updated version of an article originally published by the Investing News Network in 2015.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE


Top 5 NASDAQ Genetics Stocks of 2023

What are the top NASDAQ genetics stocks year-to-date? We run through the five biggest gainers seen in 2023.
The genetics sector supports every other life science industry in a variety of ways.

One of its major contributions is the discovery of new genetic drivers of diseases. Genetic testing has grown substantially over the last few years thanks to advances in technology; growth has also been spurred by an increase in chronic diseases and the continuing development of test kits for therapeutic areas with unmet medical needs.

Gene therapy is also a huge driver of growth in the overarching genetics market. It’s estimated that in 2023 this market was worth US$8.67 billion, and according to Grand View Research it is expected to reach an impressive US$29.51 billion by 2030, growing at a compound annual growth rate of 19.5 percent over that time period.

This important segment of the life science market is focused on how genes can help treat or prevent serious conditions in patients. This includes the potential for healthcare professionals to implement gene therapy at the cellular level instead of using medication or surgery, replacing “faulty” genes with new ones to potentially cure diseases.

Pharma and biotech companies often dabble in genetics along with their core disciplines, meaning that some firms may also have operations in other areas. The top NASDAQ genetics stocks listed below have products related to gene therapy, genetic testing, genetically defined cancers and rare genetic diseases. Data for this list was collected on December 6, 2023, using TradingView’s stock screener, with stocks listed in order of best year-to-date performance.


1. Ambrx Biopharma (NASDAQ:AMA)

Press ReleasesCompany Profile

Year-to-date gain: 316.74 percent; market cap: US$764.12 million; current share price: US$12.10

Through its expanded genetic code technology platform, clinical-stage biopharma company Ambrx Biopharma is discovering and developing engineered precision therapies. Its portfolio of advanced clinical and preclinical programs is designed to improve efficacy and safety in the treatment of a number of cancer indications, such as prostate and breast cancer.

The US Food and Drug Administration (FDA) has granted fast-track designation for ARX788 in HER2-positive metastatic breast cancer, and orphan drug designation for ARX788 in gastric cancer, while China’s National Medical Products Administration has given ARX788 breakthrough therapy designations in breast cancer. The FDA has also granted fast-track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.


2. Orchard Therapeutics (NASDAQ:ORTX)

Company Profile

Year-to-date gain: 336.96 percent; market cap: US$737.27 million; current share price: US$16.22

Global gene therapy leader Orchard Therapeutics is focused on discovering, developing and commercializing new treatments for genetic and other severe diseases. The company’s hematopoietic stem cell (HSC) gene therapy platform uses a patient’s own blood stem cells, which are genetically modified outside of the body and then reinserted. The aim is to address the underlying cause of disease in a single treatment.

In November, the FDA granted fast-track designation to Orchard’s OTL-203, an investigational HSC therapy under development for the potential treatment of the Hurler subtype of mucopolysaccharidosis type I. This is a rare, inherited neurometabolic disease caused by a deficiency of the enzymes that break down molecules such as sugars, leading to the accumulation of complex sugars in organs, including the eyes, ears and heart, as well as the musculoskeletal and central nervous systems.

The company will be initiating a global registrational trial in December to evaluate the efficacy and safety of OTL-203. This treatment candidate has received a rare pediatric disease designation from the FDA and priority medicine designations from the European Medicines Agency.


3. Reneo Pharmaceuticals (NASDAQ:RPHM)

Company Profile

Year-to-date gain: 191.98 percent; market cap: US$230.52 million; current share price: US$7.05

Reneo Pharmaceuticals is a clinical-stage company working to develop and commercialize therapies for patients with rare genetic mitochondrial diseases. Its lead product candidate is mavodelpar, which has been shown to increase the transcription of genes involved in mitochondrial function and increase fatty acid oxidation; it may also increase the production of new mitochondria.

In Q3, Reneo completed the last patient visit for its STRIDE study of mavodelpar in primary mitochondrial myopathies. The company expects to put out top-line data in the fourth quarter, and in 2024 will submit that data, along with long-term safety information, to the FDA.


4. Tempest Therapeutics (NASDAQ:TPST)

Company Profile

Year-to-date gain: 172.27 percent; market cap: US$62.36 million; current share price: US$3.30

Tempest Therapeutics is a clinical-stage oncology company advancing small-molecule therapeutics that modulate anti-tumor immunity pathways with the potential to treat a wide range of tumors. The company’s portfolio consists of clinical programs in various stages, from early research to investigational global studies.

Tempest had a number of critical catalysts in 2023, including the release of data from a first-line randomized study with Roche Holding (OTCQX:RHHBF,SWX:ROG) for its drug candidate TPST-1120, which is targeting hepatocellular carcinoma. The company also shared Phase 1 clinical data for its TPST-1495 EP2/4 prostaglandin receptor antagonist, which is targeting multiple types of solid tumors.


5. Biomea Fusion (NASDAQ:BMEA)

Company Profile

Year-to-date gain: 124.32 percent; market cap: US$675.2 million; current share price: US$18.91

Clinical-stage biopharma company Biomea Fusion’s proprietary FUSION System has allowed it to discover, develop and advance a pipeline of covalent-binding therapeutic agents targeting genetically defined cancers and metabolic diseases.

Its lead investigational drug candidate, BMF-219, is a covalent menin inhibitor with three ongoing clinical trials: a Phase 1 study for its use in treating various leukemias, large B-cell lymphoma and multiple myeloma; a Phase 1/1b study for use in treating non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma; and a Phase 1/2 study for type 2 diabetes.

Orchard's FDA investigational new drug application cleared in October for a Phase 2 clinical trial of BMF-219 in type 1 diabetes, and enrollment is anticipated to begin in Q4 2023. In early December, Health Canada also cleared the initiation of a Phase 2 clinical trial of BMF-219 for type 1 diabetes.


Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

Additional information on investing in life science stocks — FREE












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