USAPASG
IONS, MRK Lead FDA Approvals; ACHV Gets CRL; ADCT Cuts Jobs; TECH Acquired
This week brought a mix of FDA and EU approvals, layoffs, acquisitions, and clinical trial updates across the biotech sector. Ionis Pharmaceuticals secured FDA approval for TRYNGOLZA as an adjunct therapy for severe hypertriglyceridemia, while Merck received European Commission approval for Keytruda in combination with Padcev as a neoadjuvant treatment for muscle-invasive bladder cancer. Gilead's Trodelvy was cleared by the FDA for first-line metastatic triple-negative breast cancer, and Pfizer's IBRANCE won expanded approval for HR+/HER2+ metastatic breast cancer. Natera gained Japanese approval for its Signatera MRD test in colorectal cancer, and AbbVie's MAVIRET was approved in the EU for both acute and chronic Hepatitis C. Achieve Life Sciences received an FDA Complete Response Letter for its Cytisinicline NDA due to manufacturing deficiencies, though no efficacy or safety issues were raised. ADC Therapeutics announced a 17% workforce reduction as part of a strategic reorganization to focus on its ZYNLONTA lymphoma franchise. In dealmaking, Merck KGaA agreed to acquire Bio-Techne for $73 per share in cash, representing an enterprise value of $11.3 billion, while Ionis inked a licensing deal with Recordati for Zilganersen, an investigational therapy for Alexander disease. Passage Bio and Remix Therapeutics entered an all-stock merger agreement, and Boundless Bio and Serapha Bio also announced an all-stock merger. On the clinical front, IMUNON's Phase 3 OVATION 3 trial passed a safety review, Takeda's Zasocitinib showed superiority over Deucravacitinib in a Phase 3 psoriasis study, and Eledon reported positive long-term kidney transplant data for Tegoprubart. However, Pfizer's Sigvotatug vedotin missed its primary overall survival endpoint in a Phase 3 non-small cell lung cancer study, and MapLight's ML-004 failed to meet its primary endpoint in autism spectrum disorder, though it showed an irritability signal in adolescents. Definium Therapeutics reported positive Phase 3 results for DT120 ODT in major depressive disorder.