Capricor Therapeutics, Inc. CAPR
Capricor Therapeutics, Inc. (Nasdaq: CAPR) is a rare genetic drug developer. Its lead program, deramiocel, is in Phase 3 for Duchenne muscular dystrophy cardiomyopathy. Its next catalyst on record is deramiocel: FDA PDUFA target action date for BLA (extended from Aug 22) (November 22, 2026).
Upcoming catalysts
- November 22, 2026deramiocel — FDA PDUFA target action date for BLA (extended from Aug 22)
Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel ... from August 22, 2026 to November 22, 2026.
Next further out: StealthX — Final Phase 1 results (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| deramiocel | DMD | cell therapy | Phase 3 |
| StealthX exosome vaccine | Infectious disease (NIAID) | vaccine | Phase 1 |
| Exosome therapeutics | Various | biologic-other | Pre-clinical |
Recent results and decisions
- Aug 24, 2026accepted FDA accepted BLA major amendment (24-month OLE data, refined upper-limb indication) and extended PDUFA from Aug 22 to Nov 22, 2026.
the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026.
Filing - Jul 30, 2026adcomm negative FDA advisory committee voted 3 for, 9 against that evidence supports effectiveness of Deramiocel in DMD cardiomyopathy (non-binding).
voted that available evidence did not support the effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with Duchenne muscular dystrophy (DMD)
Filing - Mar 12, 2026positive MDA 2026 late-breaker: HOPE-3 cardiac MRI showed reduced myocardial fibrosis by LGE (p=0.022); LVEF +3.3 pts vs placebo in baseline cardiomyopathy (p=0.017).
Cardiac MRI analyses demonstrated a significant reduction in myocardial fibrosis as measured by late gadolinium enhancement (LGE), corresponding to a three-segment treatment difference versus placebo at 12 months (p=0.022).
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.