Evaxion Looks for New Partner for Gonorrhea Vaccine Following Merck's Withdrawal
Merck's Decision on EVX-B2: Merck & Co. has opted not to pursue Evaxion's gonorrhea vaccine candidate EVX-B2, allowing Evaxion to retain global rights and seek other licensing partners.
Gonorrhea Vaccine Landscape: Despite affecting over 80 million people annually, no gonorrhea vaccine has been approved yet, although preclinical studies show promise for EVX-B2.
Evaxion's Financial Outlook: Evaxion's CEO stated that Merck's decision does not impact their financial projections, which extend to the second half of 2027.
Recent Developments: Evaxion has successfully out-licensed another vaccine candidate, EVX-B3, to Merck, receiving an upfront payment and potential future milestone payments, while the FDA recently approved GSK's oral treatment for gonorrhea.
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- Importance of Vaccination: Jay Bhattacharya, the director of the NIH, emphasized that there is no cure for measles, making prevention critical, and that the MMR vaccine is the most reliable method to protect individuals and entire communities.
- Current Outbreak Status: South Carolina is experiencing a measles outbreak with 985 reported cases, accounting for a majority of U.S. cases, while the CDC has recorded over 1,000 cases nationwide as of February 26, indicating the severity of the situation.
- Vaccine Market Dynamics: Merck and GSK market MMR vaccines in the U.S., and with the escalating outbreak, the demand for vaccines is likely to rise significantly, potentially impacting the sales performance of both companies.
- Public Health Advocacy: Bhattacharya released a video on social media urging the public to get vaccinated, highlighting that vaccination is not only crucial for individual health but also a key measure to protect communities from the outbreak.
- Stock Surge: Toymaker Funko's shares jumped approximately 25% following Pleasant Lake Partners' urging for the company to explore strategic alternatives, indicating strong market optimism and potential for new growth avenues.
- Strategic Restructuring: Werewolf Therapeutics has hired Piper Sandler to manage a sale process, highlighting the company's proactive approach to cut operating costs by 64% through layoffs, aiming to enhance financial stability amid restructuring efforts.
- Market Dynamics: The surge in Funko's stock price, coupled with strategic recommendations from its investors, may attract further investor interest, potentially boosting its market performance and overall valuation.
- Private Equity Opportunities: In the private equity space, David Altshuler from Cresta Fund Management discussed opportunities in the energy transition market, reflecting investor interest in the potential value of Funko and similar companies.
- Dosing Frequency: ViiV Healthcare's third-generation integrase strand transfer inhibitor VH184 shows potential for dosing as infrequently as twice a year, which could significantly improve patient adherence and reduce treatment burden.
- Drug Stability: One formulation of VH184 demonstrated steady drug levels through month seven, indicating its effectiveness and safety in long-term treatment, potentially offering better options for chronic disease patients.
- Resistance Profile Advantage: VH184 exhibited an enhanced resistance profile in vitro compared to Gilead's bictegravir, suggesting a competitive edge in antiviral therapy that may attract more clinical applications.
- Clinical Trial Results: ViiV's phase 2b trial revealed that 94% of individuals receiving intravenous lotivibart maintained viral suppression, showcasing the efficacy of this combination therapy and potentially advancing its application in HIV treatment.
- Acquisition Deal: GSK plc has agreed to acquire Canada-based clinical-stage biopharmaceutical company 35Pharma for $950 million, aiming to enhance its competitive edge in novel protein therapeutics, particularly in treating pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure (PH-HFpEF).
- Clinical Advancement: The acquisition includes HS235, an investigational drug that has completed phase 1 trials in healthy volunteers, with studies set to commence imminently for PAH, indicating significant market potential as the global pulmonary hypertension therapy market is projected to reach $18 billion by 2032.
- Market Outlook: HS235 targets the activin receptor signaling pathway, expected to capture 50% of the pulmonary hypertension treatment market, and its design enhances selectivity, reducing binding to ligands associated with adverse events, showcasing its differentiated clinical application.
- Licensing Agreement: GSK has also entered into a deal with Frontier Biotechnologies, which will receive $40 million upfront and up to $963 million in milestone payments, responsible for advancing two investigational assets, while GSK will handle subsequent global clinical development and commercialization activities.
- Acquisition Agreement: GSK plc has announced the acquisition of Canada-based 35Pharma for $950 million in cash, which will enhance its product pipeline in the respiratory, immunology, and inflammation sectors.
- New Drug Development: The acquisition includes HS235, a potential investigational medicine that has completed Phase I clinical trials in healthy volunteers, with studies set to commence imminently in pulmonary arterial hypertension and heart failure-related pulmonary hypertension.
- Market Potential: HS235's profile strengthens GSK's pipeline by providing scalable opportunities in metabolic and vascular function protection, further solidifying its position in the Respiratory, Immunology, and Inflammation (RI&I) portfolio.
- Strategic Implications: This acquisition not only expands GSK's R&D capabilities but also lays the groundwork for future market demands and product diversification, demonstrating its ongoing commitment to investment in the biopharmaceutical sector.
- BHA Safety Reassessment: On February 10, 2026, the FDA initiated a comprehensive reassessment of Butylated Hydroxyanisole (BHA) to evaluate its safety in food and food contact substances based on the latest scientific data, despite its classification as a potential human carcinogen in animal studies, which could affect consumer confidence in food safety.
- Hormone Therapy Labeling Updates: On February 12, 2026, the FDA approved labeling updates for six menopausal hormone therapy products, including Prometrium and Divigel, clarifying risk considerations and removing boxed warnings related to cardiovascular disease, breast cancer, and probable dementia, which may enhance market acceptance of these therapies.
- Innovative Device Approval: On the same day, the FDA approved Novocure's Optune Pax, a first-of-its-kind device for treating locally advanced pancreatic cancer, marking a significant technological advancement in cancer treatment and potentially providing new options for patients.
- Biotech Stocks Under Scrutiny: With upcoming FDA decisions in March 2026, biotech stocks are under market scrutiny, and investors should closely monitor the potential impacts of these decisions on related companies, which could trigger market volatility.









