New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings – – Ongoing pivotal trial and FDA Type C meeting provide clear path to ...

Capricor Therapeutics updates on Deramiocel BLA for duchenne muscular dystrophy: San Diego Thursday, June 26, 2025, 15:30 Hrs [IST] Capricor Therapeutics, a biotechnology company ...

Three conditions that likely won’t qualify under the Department for Work and Pensions' new ‘severe conditions criteria’ have ...

Shares of Precision BioSciences, Inc. (NASDAQ:DTIL) jumped 17% on Wednesday after the company announced that its gene therapy candidate, PBGENE-DMD, received the Rare Pediatric Disease Designation ...

The FDA is assessing the need for “further regulatory action” on Sarepta's Duchenne muscular dystrophy gene therapy in the ...

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration will not convene its panel of outside experts before deciding on the company's cell therapy for a heart condition associated ...

FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting ...

Duchenne is a severe form of muscular dystrophy caused by the body's inability to produce dystrophin, a protein essential for muscle health. Over time, all muscles — legs, arms, lungs, and heart — ...

Capricor Therapeutics has received an orphan drug designation for its drug aimed at potentially treating Becker Muscular Dystrophy. The biotechnology company said Tuesday that the Food and Drug ...