Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed

The biopharmaceutical sector faces significant shifts as companies navigate regulatory hurdles and pipeline transitions. Capricor Therapeutics received a three-month FDA review extension for its Duchenne muscular dystrophy cell therapy, deramiocel, amid intense scrutiny and shareholder demands for strategic changes. Meanwhile, Merck and Moderna’s personalized mRNA cancer vaccine demonstrated success in a phase three melanoma trial, providing a critical boost as Merck prepares for the eventual loss of Keytruda’s market exclusivity. Regulatory leadership remains in focus with the nomination of Heidi Overton as FDA commissioner, signaling potential alignment with current priorities like non-opioid pain management and psychedelic therapies. Simultaneously, the oral obesity market intensifies, with Eli Lilly launching orforglipron in the UK and Novo Nordisk testing lower-dose Wegovy regimens to overcome manufacturing constraints and maintain competitiveness against the growing demand for weight-loss therapeutics.