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 Executive1d
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.
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 ...
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 ...
STAT2d
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 ...
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.
STAT2d
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 ...
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.
Antisense Oligonucleotide (ASO) Therapeutics Market
The increasing incidence of genetic and rare diseases is a major factor driving revenue growth in the Antisense ...