- The FDA’s 505(b)(2) pathway is an underestimated engine of value creationThe biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.BioSpace · 3d ago↗ source
- Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ reviewIf approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…BioSpace · 3d ago↗ source
- Axiom plans Hong Kong IPO, hoping to carve new path for US biotechsAxiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.