Every material Form 8-K CAPRICOR THERAPEUTICS, INC. has filed with the SEC since July 30, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Capricor Therapeutics said the FDA extended the PDUFA target action date for the Deramiocel Biologics License Application from August 22, 2026 to November 22, 2026, after classifying the company's amendment as a major amendment. The amendment adds 24-month open-label extension data from the Phase 3 HOPE-3 study and seeks review for a refined indication focused on upper limb function, which delays the timing of a possible FDA decision on the therapy.
PDUFA target action date moved from August 22, 2026 to November 22, 2026, a three-month extension
FDA classified the submission as a major amendment and accepted it for review through CBER
Amendment includes 24-month open-label extension data from the HOPE-3 study and a request to review a refined indication focused on upper limb function
CEO Linda Marbán said HOPE-3 met its primary endpoint, a statistically significant benefit in upper limb function
Capricor reported a second-quarter 2026 net loss of $40.7 million, or $0.70 per share, up from $25.9 million, or $0.57 per share, a year earlier, with no revenue recognized. The company said its FDA Advisory Committee voted 3 in favor and 9 against on cardiomyopathy efficacy for Deramiocel, and it is still working with the FDA on the Biologics License Application.
Q2 2026 net loss of $40.7 million, or $0.70 per share, versus $25.9 million, or $0.57 per share, in Q2 2025
Cash, cash equivalents and marketable securities of $237.9 million at June 30, 2026, down from $318.1 million at December 31, 2025
On July 29, 2026, the FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 3 in favor and 9 against; the vote is advisory and non-binding
NS Pharma preliminary injunction motion withdrawn; the company estimates arbitration will begin this fall
An FDA advisory committee voted on July 29, 2026 that available evidence did not support the effectiveness of Deramiocel for cardiomyopathy in Duchenne muscular dystrophy patients. The vote is non-binding, and the FDA will consider it in its ongoing review of the Biologics License Application, whose PDUFA target action date remains August 22, 2026.
Committee vote on July 29, 2026 was 3 for, 9 against and 0 abstaining
The Committee's recommendation is non-binding; the FDA will weigh it with the full administrative record
PDUFA target action date for the BLA remains August 22, 2026
In a separate upper limb function discussion, the Committee's feedback was directionally supportive of Phase 3 HOPE-3 data, including the PUL 2.0 primary endpoint
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
Only material 8-Ks get a brief: results, deals, executive changes, restructuring, impairments, delisting notices, restatements, cybersecurity incidents and other disclosed events. Routine filings (vote results, exhibits only) are skipped. Every CAPRICOR THERAPEUTICS, INC. filing is on SEC EDGAR ↗. 8-K briefs of other companies →