This Week in Biotech #39
Catch up on the latest biotech breakthroughs and upcoming trends (Feb 7-13).
Welcome to This Week in Biotech by Biotech Blueprint!
THIS WEEK’S KEY TAKEAWAYS 🔑
Yesterday’s confirmation of Robert F. Kennedy Jr. as the new U.S. Secretary of Health and Human Services has stirred debate, largely due to his controversial stance on vaccines. Despite opposition from many Democrats, who expressed concerns about his views, the Senate narrowly voted 52-48 in his favor, with only Senator Mitch McConnell voting against him. RFK Jr.’s appointment signals potential changes to U.S. health policy, particularly in relation to vaccine regulation, Medicaid and Medicare funding, and the overall direction of health agencies. While Kennedy has vowed not to interfere with current vaccine policies, his past remarks have left many skeptical about his true intentions. He claims his focus will be the “Make America Healthy Again” (MAHA) platform, which promises reforms in health programs and public health priorities.
Kennedy’s MAHA movement seeks to address chronic disease, promote healthier eating, and improve food safety. He says the goal is to combat the influence of big pharma and the food industry on public health agencies, with an emphasis on ending what he calls the “corruption” that has long influenced these bodies. These claims have raised alarm among key stakeholders, especially in the pharmaceutical and biotech sectors.
Pharmaceutical and food industry leaders have expressed concern about RFK Jr.’s influence. However, during confirmation hearings, he reassured the pharmaceutical and biotech sectors by affirming his support for vaccines. He also softened his stance on GLP-1 weight loss drugs, such as Wegovy and Zepbound, calling them “miracle drugs.” This may impact the pharmaceutical industry’s approach to compounded GLP-1s, such as those offered by Hims & Hers Health, which are affecting revenues.
For investors, Kennedy’s appointment introduces a level of uncertainty, particularly within industries reliant on government vaccine contracts. Companies like Pfizer and Moderna, which have benefited from vaccine development and distribution, could face increased scrutiny, potentially impacting their stock prices. The impact on the food industry is also noteworthy, with companies like General Mills already preparing for potential regulatory changes. Changes in how food additives, like dyes, are regulated could lead to significant shifts in consumer products and overall industry strategies. Additionally, grocery chains like Kroger, Whole Foods, and Albertson’s could stand to benefit from a health-driven agenda that prioritizes healthier eating and transparency.
🎙️ PODCAST
MARKET UPDATES
🔹 Ascendis Pharma is making waves in the biotech sector as it reports a strong fourth quarter, surpassing earnings and revenue estimates. This success is largely attributed to a beneficial collaboration deal with Novo Nordisk and the successful European market launch of Yorvipath, their latest therapeutic offering. These strategic moves spotlight Ascendis’ methodical approach to growth and expansion in the rare disease sector. The company's $100M deal with Novo underscores its commitment to forming strategic partnerships that not only boost current financial metrics but also pave the way for sustained growth. Additionally, the launch of Yorvipath in the EU marks a significant milestone, potentially increasing its market share and strengthening its presence in international markets. These factors have prompted Goldman Sachs to adjust its price target upwards, reflecting increased confidence in Ascendis’ market positioning and growth prospects.
BIOTECH NEWS
🔹 Shares of Hims & Hers Health surged 28% following the momentum from its controversial Super Bowl ad and the confirmation of Robert F. Kennedy Jr. as Health and Human Services Secretary. The ad, which gained significant attention, was ranked fifth among all Super Bowl ads for driving consumer interest. Additionally, analysts suggest that RFK Jr.’s potential leniency towards compounded weight-loss drugs could benefit Hims & Hers, as the company sells a compounded version of semaglutide, the active ingredient in Novo Nordisk’s obesity drugs. Over the past year, Hims & Hers shares have risen dramatically, adding nearly $10B in market value.
🔹 Grail and Quest Diagnostics have teamed up to streamline access to Grail’s Galleri multi-cancer early detection test for healthcare providers. Physicians can now order the Galleri test directly via Quest’s connectivity system, which integrates with over 900 electronic health record systems and the Quanum laboratory portal. This collaboration aims to enhance the ease of testing by allowing patients to receive the Galleri test at any of Quest’s 7,400 nationwide locations, without needing to bring a test kit. The Galleri test detects cancer through a simple blood draw by identifying DNA fragments from cancer cells, which act as a “fingerprint” for various cancers, including those that lack recommended screening. It is intended for adults aged 50 or older, or those at higher cancer risk, and is meant to supplement regular screenings like mammograms or colonoscopies. Grail’s (GRAL) stock went up by nearly 34% following the announcement.
🔹 AbbVie has formed a partnership with Xilio Therapeutics to develop innovative tumour-activated, antibody-based immunotherapies. The collaboration combines AbbVie’s oncology expertise with Xilio’s unique technology, which includes masked T cell engagers. Xilio will receive upfront payments of $52M, including a $10M equity investment, and could earn up to $2.1B in potential payments, including milestones and royalties. Xilio’s platform technology, which has been clinically validated, allows for the development of therapies that selectively target tumours, reducing systemic side effects. This collaboration is expected to accelerate next-generation immunotherapies, including T cell engagers.
🔹 BridgeBio Pharma announced that the European Commission has granted marketing authorization for Acoramidis (brand name Beyonttra) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM). This approval follows positive results from the phase 3 ATTRibute-CM study, where acoramidis showed rapid benefits in as few as three months, including a 42% reduction in cardiovascular-related hospitalizations. Bayer will commercialize Beyonttra in the EU, and BridgeBio will receive a $75M milestone payment, along with royalties from sales in the EU. The drug is already approved in the U.S. as Attruby and is under review in Japan and Brazil.
🔹 On Feb. 11, Biohaven announced that the FDA has accepted its New Drug Application (NDA) for troriluzole to treat spinocerebellar ataxia (SCA), a rare, life-threatening neurodegenerative disease. The FDA granted Priority Review, expediting the approval process due to the lack of existing treatments for SCA. Troriluzole has demonstrated a 50-70% slowing of disease progression in a 3-year study, and if approved, it will be the first FDA-approved treatment for SCA. Biohaven plans to launch the drug in 2025 if approval is granted.
🔹 Several small biotech companies are developing new obesity treatments with unique mechanisms of action. Skye Biosciences is working on nimacimab, a CB1 inhibitor that preserves lean muscle mass and energy expenditure without crossing the blood-brain barrier, avoiding side effects seen in earlier CB1 inhibitors. Scholar Rock is exploring apitegromab, an antibody that preserves lean muscle, as an obesity treatment, potentially combined with Eli Lilly’s Zepbound. MBX Biosciences is advancing MBX4291, with an IND filing expected in 2025. Experts expect future weight loss treatments to offer fewer side effects, better efficacy, and new mechanisms.
🔹 The FDA has approved Emblaveo (aztreonam and avibactam), a combination antibiotic, to treat complicated intra-abdominal infections (cIAI) in adults with limited or no treatment options. Emblaveo is the first monobactam/β-lactamase inhibitor combination approved for this purpose. It targets infections caused by bacteria such as Escherichia coli and Klebsiella pneumoniae. This approval addresses the growing global issue of antimicrobial resistance, which poses a severe public health threat, potentially causing over 39 million deaths by 2050. The drug is expected to be available in the U.S. by Q3 2025.
🔹 Twelve universities and three education groups have filed a lawsuit against the NIH and HHS, challenging a new policy that imposes a 15% cap on research grant funding for facilities and administration costs. The plaintiffs argue that the NIH’s policy violates congressional statutes that protect existing indirect cost reimbursement rates, which were previously safeguarded in 2017. The lawsuit, filed in Massachusetts, claims that these funding cuts would severely disrupt essential research, particularly in medical and scientific fields, and could even cause smaller institutions to close. A federal judge temporarily halted the funding cap while litigation continues, with a hearing set for Feb. 21, 2025.
CLINICAL TRIAL UPDATES
🔹 AnaptysBio announced that its investigational treatment, rosnilimab, showed promising results in its phase 2b RENOIR trial for rheumatoid arthritis. The treatment achieved statistically significant results on primary and key secondary endpoints at week 12, including a notable reduction in disease activity and sustained responses up to week 14. Rosnilimab was well tolerated, with a favorable safety profile similar to placebo. At week 14, 69% of patients reached low disease activity, with positive responses continuing through week 28. As a result, AnaptysBio’s (ANAB) stock surged by 20%.
🔹 Inovio’s phase 1/2 trial of INO-3107, a DNA medicine designed to treat recurrent respiratory papillomatosis caused by HPV-6 and HPV-11, has shown promising results, as published in Nature Communications. The treatment induced new T cell populations that targeted HPV-infected tissues, leading to clinical benefits. Specifically, 81% of patients required fewer surgeries post-treatment, with 28% experiencing no surgeries at all. The therapy was well tolerated, with mild side effects such as injection site pain and fatigue. INO-3107 generated long-lasting T cell responses, offering potential for reducing the need for frequent surgeries, which carry risks like vocal cord damage. Inovio plans to submit a biologics license application for INO-3107 in mid-2025.
PUBLIC HEALTH SPOTLIGHT
🔹 As of Feb. 7, New York City has temporarily closed all live poultry markets due to an avian influenza outbreak detected in seven markets across the city and nearby counties (Queens, the Bronx, Brooklyn, Westchester, Suffolk, and Nassau). The closure, lasting five days, will allow for cleaning and disinfection to prevent further spread. Since 2022, the virus has led to the destruction of over 156 million birds nationwide, causing egg shortages and rising prices. Wild birds can transmit the virus to poultry, and the USDA has recently confirmed a second bird flu strain in dairy cattle, heightening concerns about its spread.
ON THE HORIZON
🔹 Upcoming biotech IPOs:
Feb. 19: Anbio Biotechnology (NNNN) is a company focused on advancing medical technology and providing in vitro diagnostics products. With a commitment to transforming the global diagnostics landscape, Anbio aims to drive a shift toward personalized and decentralized diagnostic solutions. The company offers a broad range of IVD products for applications including over-the-counter, point-of-care, and laboratory settings, addressing critical areas such as infectious diseases, cancer, cardiovascular conditions, and diabetes. Anbio is offering 1.6M shares in its upcoming IPO, with a price range of $5.00 to $6.00 per share.
Feb. 21: Apimeds Pharmaceuticals US, Inc. (APUS) is a clinical-stage biopharmaceutical company focused on developing Apitox, a bee venom-based toxin administered intradermally with potential therapeutic benefits. Currently marketed in South Korea as Apitoxin, the drug has been approved by the Korean Ministry of Food and Drug Safety to treat osteoarthritis pain and mobility issues. Apimeds is now advancing its development in the U.S., targeting knee pain in osteoarthritis patients who have not responded to conventional treatments. The company is offering 4.5M shares in its upcoming IPO, priced between $4.00 and $5.00 per share.
🔹 Remaining February FDA PDUFAs:
Feb. 14: GSK’s 5-in-1 meningococcal ABCWY vaccine candidate.
Feb. 14: Bavarian Nordic is expecting the FDA’s decision for the CHIKV VLP vaccine.
Feb. 28: SpringWorks Therapeutics’ NDA mirdametinib for treating adults and children with NF1-PN.
Have a great rest of your week and thanks for reading Biotech Blueprint.
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DISCLAIMER: This content is for informational purposes only. It should not be taken as legal, tax, investment, financial, or other advice. The views expressed here are my own and do not reflect the opinions of any company or institution.
DISCLOSURE: I have no business relationships with any company mentioned in this article.
Good stuff Katerina! 🤛🏽💗