Linda Marbán, CEO of Capricor Therapeutics Inc., discusses deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating Duchenne muscular dystrophy. The company just wrapped up a visit with the U.S. FDA and is prepping to file a BLA for its treatment of the rare disease.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Biomea Fusion, Crinetics, Formycon, Fresenius Kabi, Regeneron, Sanofi, Xbrane.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cassava Sciences, Phare Bio.

A quick look back at top stories.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alumis, Bayer, Bluerock, Janssen, Travere, UCB.

Biopharmas raising money in public or private financings, including: Cue, Eyenovia, Nurexone, Theriva.

New hires and promotions in the biopharma industry, including: Alterity, Gentibio, Klotho, Prothena, Vor.

The top 10 biopharma stock gainers and losers for the week.

Year-to-date money raised in public, private and other financings of biopharma companies.