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CAPR stock rallied nearly 30% so far this week — here’s the February FDA catalyst investors are betting on

The February filing centers on Deramiocel’s Phase 3 Hope-3 data, following the FDA's request for the full clinical study report without requiring new trials. ・The company's Phase 3 results showed ...
Yahoo

FDA turns back Capricor’s Duchenne cell therapy

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has rejected what was ...
FierceBiotech

FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims

Capricor Therapeutics has publicly released its July response to the FDA's rejection of its Duchenne muscular dystrophy cell therapy deramiocel after the agency included deramiocel in a new batch of ...
Nasdaq

Capricor Therapeutics to Resubmit BLA for Deramiocel Following FDA Complete Response Letter, Plans to Include Phase 3 HOPE-3 Trial Data

Capricor plans to resubmit its BLA to the FDA, incorporating data from the ongoing Phase 3 HOPE-3 trial, indicating proactive steps toward potential approval for Deramiocel. The FDA's invitation for ...
MedCity News

FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease

Capricor Therapeutics’ cell therapy for Duchenne muscular dystrophy has come up short at the FDA, with the regulator rejecting the biotech’s application seeking regulatory approval for what the ...
Hosted on MSN

Capricor refutes FDA’s DMD deramiocel rejection in public statement

Capricor Therapeutics has publicised a statement addressing the US Food and Drug Administration’s (FDA) decision to reject its Duchenne muscular dystrophy (DMD) drug deramiocel. This comes after the ...
STAT

FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...
Morningstar

Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel

However, the FDA did not release the comprehensive preliminary response that Capricor submitted shortly after receipt of the CRL. This written response provided clarifications to the Agency’s feedback ...
FierceBiotech

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 questions about whether the agency's new leadership may be rowing back from ...
Morningstar

Capricor: FDA Posting of Rejection Letter Didn't Include Response

Capricor Therapeutics is raising issues with the U.S. Food and Drug Administration's new policy of publishing rejection letters sent to drugmakers. The FDA in June began publishing older letters, ...
Seeking Alpha

Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel

SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (CAPR) (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, ...