Monitor the July 29 AdCom webcast for voting outcome and FDA panel commentary. Stock volatility is expected around the meeting and the August 22 PDUFA date. A positive vote would increase approval probability; a negative vote would raise uncertainty.
Price Chart
Executive Summary
Capricor announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will meet on July 29, 2026 to review the BLA for Deramiocel (Duchenne muscular dystrophy). The PDUFA target action date remains August 22, 2026. This sets a binary catalyst with significant stock-moving potential.
Key Facts
- FDA Advisory Committee meeting scheduled for July 29, 2026 to discuss Deramiocel BLA for Duchenne muscular dystrophy
- PDUFA target action date remains August 22, 2026
- BLA supported by Phase 3 HOPE-3 trial which achieved statistical significance on primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF)
- Deramiocel has Orphan Drug, RMAT, ATMP, and Rare Pediatric Disease designations
Financial Impact
No financial data in filing; binary regulatory catalyst with potential to significantly impact stock price based on AdCom outcome
Risk Factors
- Advisory committee could vote against approval, reducing likelihood of FDA clearance
- FDA may not follow the committee's recommendation, adding uncertainty to the PDUFA decision
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-078327 |
| Document: capr-20260626xex99d1.htm | 0001104659-26-078327 |
| Document: 0001104659-26-078327-index-headers.html | 0001104659-26-078327 |
| Document: 0001104659-26-078327-index.html | 0001104659-26-078327 |
| Document: 0001104659-26-078327.txt | 0001104659-26-078327 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 11d ago | SC 13G/A | $7.27 $6.13 | ▲ +15.68% | ▲ +14.67% | $5.74 (+21.05%) |
Aug 24, 2026 9w ago | 8-K | $6.80 $9.91 | ▼ −45.74% | ▼ −45.27% | $5.74 (+15.59%) |
Aug 21, 2026 9w ago | Institutional Cluster | $6.29 $9.59 | ▲ +52.46% | ▲ +51.99% | $5.74 (−8.74%) |
Jul 30, 2026 12w ago | Press Release | $4.19 $4.18 | ▲ +0.24% | ▲ +3.86% | $5.74 (−36.99%) |
Jul 14, 2026 14w ago | 8-K | $20.35 $18.91 | ▼ −7.08% | ▼ −6.10% | $5.74 (−71.79%) |
Jun 29, 2026 16w ago | Insider Cluster | $24.08 $22.43 | ▼ −6.85% | ▼ −7.46% | $5.74 (−76.16%) |
Jun 26, 2026 17w ago | 8-K | $23.80 $22.43 | ▼ −5.76% | ▼ −7.14% | $5.74 (−75.88%) |
Jun 24, 2026 17w ago | Insider Cluster | $30.40 $23.07 | ▼ −24.11% | ▼ −25.67% | $5.74 (−81.12%) |
Jun 1, 2026 21w ago | Court Ruling | $27.34 $26.01 | ▼ −4.86% | ▼ −1.90% | $5.74 (−79.01%) |
May 12, 2026 23w ago | Press Release | $30.33 $26.92 | ▼ −11.24% | ▼ −10.09% | $5.74 (−81.07%) |
US Market Status
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