News

Solid Biosciences: SGT-003's Safety Profile Illuminates DMD Gene Therapy Path (Rating Upgrade)
Solid Biosciences' DMD gene therapy shows promise with SGT-003 and strong cash backing through 2027. Click here to read an ...
Managed Healthcare Executive2d
Capricor’s DMD Cell Therapy Faces FDA Setback
The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
Capricor shares sink as US FDA declines to approve cell therapy
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the company said on Friday, sending its shares tumbling 30% in early trading.
BioPharma Dive2d
FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...
BioSpace2d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Fierce Biotech2d
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 ...
BioSpace2d
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 ...
Stocktwits on MSN2d
Capricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder Therapy
Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell ...
The American Journal of Managed Care2d
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.
STAT3d
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 shares sink after US FDA declines approval for muscle disorder therapy
The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked for more data, the drugmaker said on Friday, sending its shares 50% ...
Pricing watchdog will take on the rising cost of drugs at launch
ICER’s upcoming report could shed light on how the launch price of newly approved drugs affects overall cost and access from ...