2024 Biotech Outlook Report
Invest in a sector that is expected to be worth US$3.08 trillion by 2030!
The Investing News Network spoke with analysts, market watchers and insiders about which trends will impact this sector in days ahead.
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A Sneak Peek At What The Insiders Are Saying
"Ample corporate cash, the need to continue to invest to address medium-term pipeline gaps and the resetting of biotech valuations will provide the backdrop for an active year."
— Roel van den Akker, PwC
“Pharma and biotech companies will likely look to trim operating expenses and focus on assets certain to be differentiators."
— BMO Capital Markets
“Scale is important in the healthcare industry, and for that reason we favor owning the largest names in the category. In addition, we expect continued market volatility next year, which favors a covered call strategy."
— Raj Lala, Evolve Funds
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2024 Biotech Outlook Report
Table of Contents
Biotech Market Forecast: Top Trends That Will Affect Biotech in 2024
Biotech Market Update: Q1 2024 in Review
Biotech Market Forecast: Top Trends That Will Affect Biotech in 2024
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.
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Biotech Market Update: Q1 2024 in Review
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.
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Top 5 NASDAQ Biotech Stocks of 2023
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)
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)
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.
3. Mereo BioPharma (NASDAQ:MREO)
Year-to-date gain: 215.09 percent; market cap: US$218.77 million; share price: US$3.28
Mereo BioPharma is a clinical-stage biopharmaceutical company focused on rare diseases and cancer.
The most advanced product candidate in the company’s pipeline is setrusumab for the treatment of osteogenesis imperfecta (OI). The FDA has granted setrusumab an orphan drug designation and a pediatric disease designation for OI. The European Medicines Agency has also granted setrusumab an orphan drug designation, as well as a PRIME designation that supports the development of medicines that target an unmet medical need.
Part of Mereo's focus this year has been late-stage clinical trials of setrusumab in pediatric and young adult OI patients. They are being completed through the company's partnership with Ultragenyx Pharmaceutical (NASDAQ: RARE).
The first patients for both trials were dosed in July, and in October Mereo and Ultragenyx announced that interim data from the Phase 2 portion of the Phase 2/3 Orbit study on young adults showed that treatment with setrusumab significantly reduced fractures in patients with at least six months of follow up. The patients also showed improvements in lumbar spine bone mineral density. Mereo's share price hit its highest point in 2023 on November 7, reaching US$2.39.
4. Immix Biopharma (NASDAQ:IMMX)
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)
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.
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Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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Top 3 Canadian Biotech Stocks of 2024
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)
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)
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)
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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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Cardiol Therapeutics is a client of the Investing News Network. This article is not paid-for content.
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