News

RBC Capital Maintains a Buy Rating on Dyne Therapeutics (DYN) With a $25 PT
Dyne Therapeutics, Inc. (NASDAQ:DYN) is one of the 13 Best Healthcare Stocks to Buy Under $10. In a report released on July 7 ...
The Pharma Letter2h
FDA slaps CRL on Capricor’s deramiocel BLA
US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...
Muscular Dystrophy News3h
Finding solace: Why I need July’s slower pace
Columnist Betty Vertin embraces July's slower pace, a much-needed respite from caregiving demands for her family of nine.
BioPharma Dive3h
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
Asianet Newsable on MSN3h
Capricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder Therapy
The FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does ...
Fierce Biotech4h
FDA rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
BioSpace4h
Capricor Plunges on FDA Rejection of DMD Cell Therapy
In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...
STAT4h
Questions about the FDA’s ‘radical transparency’ efforts
Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...
The American Journal of Managed Care4h
TAS-205 Misses Primary End Point in Phase 3 DMD Trial
TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.
InvestorsHub on MSN4h
Capricor Shares Tumble After FDA Rejects Duchenne Therapy Application
Capricor Therapeutics (NASDAQ:CAPR) saw its stock plummet by 53% on Friday after the U.S. Food and Drug Administration issued a Complete Response Letter (CRL), rejecting the company’s bid for approval ...
STAT5h
FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
Capricor Therapeutics Shares Plunge Premarket on FDA Setback
Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead ...