Executive Briefing for November 19 2025

Headline Findings:

• Merck has announced a definitive agreement to acquire Cidara Therapeutics for $9.2 billion, marking one of 2025’s largest infectious disease M&A deals and signaling continued large pharma consolidation in specialty portfolios.
• FDA has added a black box warning for serious liver toxicities and risk of death to Sarepta’s Elevidys gene therapy, removing the nonambulatory indication—establishing a precedent for heightened post-approval gene therapy oversight.
• Rick Pazdur has been appointed head of FDA’s Center for Drug Evaluation and Research (CDER), potentially accelerating oncology reviews amid reported tensions between FDA Commissioner Makary and Health Secretary Kennedy.
• Novo Nordisk and Eli Lilly have agreed to offer GLP-1 drugs at significantly lower prices through a new U.S. direct-to-consumer platform, potentially disrupting pricing power and reimbursement strategies across the obesity and diabetes sectors.

M&A Activity:

• Johnson & Johnson completed a $3 billion acquisition of Halda Therapeutics, gaining their protein degradation platform and intensifying competition in this modality.
• Hanmi Pharmaceutical is acquiring Aptose Biosciences, securing tuspetinib—an AML therapy showing 100% complete remission rates in early cohorts with difficult-to-treat mutations.
• A competitive bidding war between Lundbeck and Alkermes for Avadel Pharmaceuticals is underway, potentially setting new valuation benchmarks for specialty CNS assets.

Regulatory Developments:

• Sarepta must now conduct a postmarketing observational study of approximately 200 Elevidys patients following the FDA’s label restrictions.
• YolTech Therapeutics received FDA IND clearance for YOLT-203, a pivotal global trial of an in vivo gene-editing therapy for Primary Hyperoxaluria Type 1.
• Piramal Pharma Solutions’ Grangemouth facility received updated MHRA GMP certificates, strengthening its position as a key CDMO for antibody-drug conjugates.

Market Trends:

• The Merck-Cidara and J&J-Halda acquisitions collectively signal heightened valuation expectations for platform technologies and late-stage assets.
• Expanded ADC manufacturing capacity at regulatory-compliant facilities may accelerate timelines for oncology biotechs relying on CDMO partners.
• Cross-border M&A activity continues to increase, with Asian pharma companies actively pursuing direct North American market access through strategic acquisitions.

Further Notable Analysis:

• AGC Biologics and Repair Biotechnologies announced a partnership to develop mRNA therapeutics for atherosclerotic plaque stabilization, signaling mRNA’s expansion beyond infectious disease and oncology.
• Hemispherian AS received U.S. patent allowance for GLIX1, a first-in-class TET2-activating therapy for difficult-to-treat cancers, strengthening its IP position in epigenetic oncology.
• Biocentis raised $19M for programmable insect control technology, indicating growing investor interest in synthetic biology applications for vector-borne disease markets.