Capricor Therapeutics, Inc. (CAPR)
NASDAQ:CAPR
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Earnings Data
Report Date
Aug 12, 2026After Close (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
-0.59Last Year’s EPS
-0.57Same Quarter Last Year
Strong Buy
Based on 8 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong clinical and regulatory progress for deramiocel — statistically significant phase 3 efficacy (primary and cardiac secondary endpoints), robust long-term safety exposure, active BLA review with a clear PDUFA date, in-house manufacturing capabilities and a solid cash runway. Management also articulated a concrete commercialization plan and eligibility for a monetizable Priority Review Voucher. Offsetting these positives are notable near-term risks: an active lawsuit with NS Pharma that creates distribution uncertainty (and potential need to repay $50M), rising operating expenses and no current product revenue, manufacturing labeling constraints for an ultra-cold-chain therapy, and unresolved ASP/AMP payer complexities that could affect access. On balance, the material clinical/regulatory achievements and internal control of manufacturing and cash resources outweigh the legal and commercial execution risks, but the litigation and payer/pricing issues remain important near-term uncertainties.Company Guidance
Pivotal Phase 3 Efficacy — HOPE-3 Met Primary Endpoint
HOPE-3 (n=106) met its primary endpoint (PUL v2.0) with ~54% reduction in disease severity at 12 months (p=0.029). All type-1-error controlled secondary endpoints were also significant, supporting clinical benefit in Duchenne muscular dystrophy (DMD).
Strong Cardiac Signal in Key Secondary Endpoint
Left ventricular ejection fraction (LVEF) showed ~91% slowing of disease progression in all evaluable patients and ~120% slowing in the subset with confirmed cardiomyopathy (p=0.01), supporting deramiocel's potential to address DMD-associated cardiomyopathy.
Regulatory Progress — BLA Under Active Review with PDUFA Date
Biologics License Application (BLA) resubmission accepted as a Class 2 filing; FDA active review with a PDUFA target action date of August 22, 2026. Multiple information requests have been addressed and labeling discussions are anticipated.
Safety and Long-Term Exposure Data
Deramiocel safety profile supported by >800 intravenous infusions across studies and ~90 patients in open-label extension (OLE) studies with some patients receiving continuous infusions up to 5 years, reinforcing long-term tolerability.
Manufacturing Infrastructure and Scale Plan
In-house GMP facility in San Diego completed FDA pre-license inspection with observations addressed; current capacity to support ~200–250 patients/year (≈1,000 doses/year) with staged expansion to support ~2,000–2,500 patients/year (≈10,000 doses/year). Full validation target: 2027.
Strong Cash Position & Runway
Cash, cash equivalents and marketable securities of approximately $279 million as of 03/31/2026. Management believes this capital is sufficient to fund anticipated operating expenses and capital expenditures into 2027 (excludes potential product revenue or Priority Review Voucher monetization).
Priority Review Voucher (PRV) Opportunity
Company expects eligibility for a transferable Priority Review Voucher upon potential approval, representing a potentially meaningful, monetizable source of non-dilutive capital.
Pipeline and Lifecycle Expansion Efforts
Ongoing work on exosome-based therapeutics (StealthX/HEK293 exosomes) and plans for lifecycle management of deramiocel including expansion to younger DMD patients and a planned clinical pathway for Becker muscular dystrophy; EMA and PMDA engagements expected later in the year.
CAPR Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
CAPR Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
May 12, 2026 | $31.52 | $30.33 | -3.78% |
Mar 12, 2026 | $33.42 | $30.50 | -8.74% |
Nov 10, 2025 | $5.56 | $6.20 | +11.51% |
Aug 11, 2025 | $7.82 | $8.04 | +2.88% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Capricor Therapeutics, Inc. (CAPR) report earnings?
Capricor Therapeutics, Inc. (CAPR) is schdueled to report earning on Aug 12, 2026, After Close (Confirmed).
What is Capricor Therapeutics, Inc. (CAPR) earnings time?
Capricor Therapeutics, Inc. (CAPR) earnings time is at Aug 12, 2026, After Close (Confirmed).
Where can I see when companies are reporting earnings?
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What companies are reporting earnings today?
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What is CAPR EPS forecast?
CAPR EPS forecast for the fiscal quarter 2026 (Q2) is -0.59.