The European Medicines Agency (EMA) has officially validated the marketing authorization application for DATROWAY® (datopotamab deruxtecan), a novel antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitors.
Takeda Pharmaceutical Company (NYSE:TAK) has announced positive topline results from its two pivotal Phase 3 trials evaluating zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis.
VYNE Therapeutics (NASDAQ:VYNE) and Yarrow Bioscience have entered into a definitive all-stock merger agreement, with the combined company expected to operate under the name Yarrow Bioscience and trade on Nasdaq under the ticker YARW.
Processa Pharmaceuticals (NASDAQ:PCSA) provided a Phase 2 clinical update for its combination therapy, NGC-Cap (PCS6422 + capecitabine), on December 17, 2025.
Vistagen (NASDAQ:VTGN) announced disappointing results from its PALISADE-3 Phase 3 clinical trial of intranasal fasedienol, a treatment for social anxiety disorder.
The study failed to meet its primary endpoint, which was based on the change from baseline in the Subjective Units of Distress Scale (SUDS).
Traws Pharma (NASDAQ:TRAW) reported promising interim results from its Phase 2 trial of ratutrelvir, a ritonavir-free Mpro inhibitor, in the treatment of COVID-19.
The oral treatment, administered at a 600 mg once-daily dose for 10 days, was compared against PAXLOVID™ in a randomized, open-label study involving 37 patients—25 receiving ratutrelvir and 12 receiving PAXLOVID™.
Dyadic (NASDAQ:DYAI) has expanded its strategic collaboration with Fermbox Bio to enhance the manufacturing, commercialization, and dual-sourcing of animal-free proteins and enzymes developed by Dyadic.
NorthStrive Biosciences (NASDAQ:ELAB) has launched Phase III of its AI Development Program in collaboration with Yuva Biosciences, aiming to validate small-molecule candidates for muscle preservation through mitochondrial function enhancement.
Cytokinetics (NASDAQ:CYTK) announced that its drug MYQORZO (aficamten) has received approval from the National Medical Products Administration (NMPA) in China for the treatment of adults with NYHA class II-III obstructive hypertrophic cardiomyopathy.
ABM (NYSE:ABM) has announced its agreement to acquire WGNSTAR in a cash transaction valued at approximately $275 million.
Merck (NYSE:MRK) announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
Pfizer (NYSE:PFE) and Astellas have announced positive topline results from the interim analysis of the Phase 3 EV-304 (KEYNOTE-B15) trial, evaluating the combination of PADCEV (enfortumab vedotin) and Keytruda (pembrolizumab) in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC).
