CAPR Updates FDA on Deramiocel BLA, Plans HOPE-3 CSR Filing in February

CAPR said the FDA wants the full HOPE-3 study report for Deramiocel and confirmed no new clinical trials are needed.

Zacks Investment Research • Jan 21, 2026

Here's Why This Biotechnology Skyrocketed by 439% in December

The Phase 3 trial met its primary and secondary endpoints. Management anticipates approval in 2026, with highly lucrative milestone payments expected to follow in the years to come.

The Motley Fool • Jan 9, 2026

Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Trial Results and Regulatory Path for Duchenne Muscular Dystrophy Therapy Transcript

Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Trial Results and Regulatory Path for Duchenne Muscular Dystrophy Therapy Transcript

Seeking Alpha • Dec 18, 2025

Capricor: Maintaining 'Hold' Rating On Randomized Phase 3 HOPE-3 Trial Win With Deramiocel

Capricor Therapeutics maintains a "Hold" rating despite positive phase 3 HOPE-3 results for Deramiocel in DMD cardiomyopathy. HOPE-3 met both primary [PUL v2.0] and key secondary [LVEF] endpoints, aligning with FDA's requirements for potential BLA resubmission of Deramiocel. Regulatory uncertainty remains, particularly regarding CMC issues and whether or not HOPE-3 fully satisfies FDA approval criteria.

Seeking Alpha • Dec 7, 2025

Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Top Line Data for Deramiocel in Duchenne Muscular Dystrophy Transcript

Capricor Therapeutics, Inc. (CAPR) Discusses HOPE-3 Phase III Top Line Data for Deramiocel in Duchenne Muscular Dystrophy Transcript

Seeking Alpha • Dec 6, 2025

CAPR Stock Skyrockets 282% in a Week: Here's What You Need to Know

Capricor Therapeutics stock soars after meeting key goals with statistical significance in a phase III study of deramiocel for Duchenne cardiomyopathy.

Zacks Investment Research • Dec 5, 2025

Capricor Therapeutics Announces Proposed Public Offering of Common Stock

SAN DIEGO, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics, today announced the commencement of a proposed underwritten public offering of shares of its common stock. In addition, Capricor intends to grant the underwriters a 30-day option to purchase an additional number of shares of common stock equal to 15% of the aggregate number of shares of its common stock sold in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

GlobeNewsWire • Dec 4, 2025

Capricor's muscle disorder cell therapy succeeds in late-stage study

Capricor Therapeutics said on Wednesday its cell therapy for a heart condition related to a rare muscular disorder met the main goal of a late-stage study, months after U.S. regulators rejected its initial approval bid.

Reuters • Dec 3, 2025

Capricor Skyrockets 535% After Getting Vindication In Muscular Dystrophy

Capricor stock skyrocketed to an eight-year high Wednesday on positive results for its Duchenne muscular dystrophy treatment.

Investors Business Daily • Dec 3, 2025

Biotech Stock Up Over 400% After Late-Stage Breakthrough

Capricor Therapeutics Inc (NASDAQ:CAPR) is one of the best stocks on Wall Street today, up 263% to trade at $23.09, after the biotech company's cell therapy for a heart condition related to Duchenne's muscular dystrophy met the ‌main goal of a late-stage study.

Schaeffers Research • Dec 3, 2025