The stock will trade primarily on Deramiocel approval odds ahead of the August 22 PDUFA date. The EPS miss is secondary for a pre-revenue biotech. Watch for FDA labeling discussions and any updates on the NS Pharma lawsuit — a favorable resolution could remove a distribution overhang. The $278.6M cash runway into Q4 2027 provides ample time for launch without dilutive financing near-term.
Price Chart
Executive Summary
Capricor Therapeutics reported Q1 2026 EPS of -$0.59, missing consensus of -$0.54 by ~9.3%, with no revenue. The key catalyst is the August 22, 2026 PDUFA date for Deramiocel in Duchenne muscular dystrophy, and the company has $278.6M cash to fund operations into Q4 2027. The filing also disclosed a lawsuit against NS Pharma to rescind the distribution agreement, which does not affect the FDA review timeline.
Key Financial Metrics
Key Facts
- EPS of -$0.59 missed consensus of -$0.54 (9.3% miss); no revenue reported
- Cash, cash equivalents and marketable securities: $278.6M as of March 31, 2026, down from $318.1M at year-end 2025
- Net loss widened to $33.9M from $24.4M in Q1 2025, driven by higher R&D and G&A expenses
- PDUFA target action date for Deramiocel BLA is August 22, 2026; labeling discussions expected soon
- Filed suit against Nippon Shinyaku/NS Pharma on May 7, 2026 seeking rescission of distribution agreement; FDA review unaffected
- GMP manufacturing facility passed FDA Pre-License Inspection; second-floor expansion targeting 2,000-2,500 patients/year by H1 2027
- Eligible for a Priority Review Voucher upon potential approval, which could be monetized for non-dilutive capital
- Cash runway expected to support operations into Q4 2027, excluding potential product revenue or PRV monetization
Financial Impact
Net loss of $33.9M in Q1 2026 vs $24.4M in Q1 2025; cash burn of ~$39.5M in the quarter
Risk Factors
- FDA non-approval or complete response letter for Deramiocel would be a severe negative catalyst
- NS Pharma lawsuit could complicate or delay commercial launch if not resolved favorably
- Cash burn rate increased 48% YoY; if approval is delayed, additional capital may be needed
- Competing DMD therapies (e.g., gene therapies) could limit Deramiocel's market opportunity
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3293375 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 14, 2026 12d ago | SC 13G/A | $7.27 $6.13 | ▲ +15.68% | ▲ +14.67% | $5.85 (+19.53%) |
Aug 24, 2026 9w ago | 8-K | $6.80 $9.91 | ▼ −45.74% | ▼ −45.27% | $5.85 (+13.97%) |
Aug 21, 2026 9w ago | Institutional Cluster | $6.29 $9.59 | ▲ +52.46% | ▲ +51.99% | $5.85 (−7.00%) |
Jul 30, 2026 12w ago | Press Release | $4.19 $4.18 | ▲ +0.24% | ▲ +3.86% | $5.85 (−39.62%) |
Jul 14, 2026 14w ago | 8-K | $20.35 $18.91 | ▼ −7.08% | ▼ −6.10% | $5.85 (−71.25%) |
Jun 29, 2026 17w ago | Insider Cluster | $24.08 $22.43 | ▼ −6.85% | ▼ −7.46% | $5.85 (−75.71%) |
Jun 26, 2026 17w ago | 8-K | $23.80 $22.43 | ▼ −5.76% | ▼ −7.14% | $5.85 (−75.42%) |
Jun 24, 2026 17w ago | Insider Cluster | $30.40 $23.07 | ▼ −24.11% | ▼ −25.67% | $5.85 (−80.76%) |
Jun 1, 2026 21w ago | Court Ruling | $27.34 $26.01 | ▼ −4.86% | ▼ −1.90% | $5.85 (−78.60%) |
May 12, 2026 23w ago | Press Release | $30.33 $26.92 | ▼ −11.24% | ▼ −10.09% | $5.85 (−80.71%) |
US Market Status
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