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 ...
BioPharma Dive12h
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.
BioSpace12h
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 MSN13h
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 Care13h
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 MSN13h
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 ...
STAT13h
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 ...
BioSpace14h
FDA’s 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 ...
US FDA declines to approve Capricor's muscle disorder therapy
Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.
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 ...
Clinical Trials Arena3d
Taiho’s DMD therapy misses the mark in Phase III trial
Taiho Pharmaceutical’s investigational Duchenne muscular dystrophy (DMD) therapy, pizuglanstat, has shown no benefit in a Phase III trial.