Earnings summaries and quarterly performance for CAPRICOR THERAPEUTICS.
Executive leadership at CAPRICOR THERAPEUTICS.
Board of directors at CAPRICOR THERAPEUTICS.
Research analysts who have asked questions during CAPRICOR THERAPEUTICS earnings calls.
ET
Edward Tenthoff
Piper Sandler Companies
4 questions for CAPR
Also covers: ARVN, ARWR, CLRB +14 more
Kristen Kluska
Cantor Fitzgerald
4 questions for CAPR
Also covers: ABEO, ADMA, AQST +24 more
LG
Leland Gershell
Oppenheimer & Co. Inc.
4 questions for CAPR
Also covers: ARGX, ASND, CASI +13 more
Aydin Huseynov
Ladenburg Thalmann
3 questions for CAPR
Also covers: ARDX, CLRB, CMPX +3 more
Catherine Novack
JonesTrading Institutional Services LLC
3 questions for CAPR
Also covers: ALDX, CRNX, DARE +3 more
Joseph Pantginis
H.C. Wainwright & Co.
2 questions for CAPR
Also covers: ARMP, BCDA, BLRX +15 more
MW
Madison Wynne El-Saadi
B. Riley Securities
2 questions for CAPR
Also covers: AGEN, ETON, VTGN +1 more
BP
Boobalan Pachaiyappan
ROTH Capital Partners
1 question for CAPR
Also covers: ADXN, LGVN, PYPD +3 more
BP
Bubalan Pachayapan
ROTH Capital
1 question for CAPR
CL
Chris Lemos
NADA
1 question for CAPR
IH
Ivan Hosinov
Vladimir Pharma
1 question for CAPR
MV
Matthew Venezia
Alliance Global Partners
1 question for CAPR
Also covers: ABEO, CBUS
Recent press releases and 8-K filings for CAPR.
Capricor Therapeutics Provides Deramiocel BLA Regulatory Update
CAPR
- Capricor Therapeutics provided a regulatory update for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
- The FDA requested the full HOPE-3 clinical study report (CSR) and supporting data, without requiring additional clinical studies or new patient data.
- Capricor expects to submit these materials to the FDA in February 2026 to address the Complete Response Letter (CRL) and facilitate continued BLA review.
Jan 20, 2026, 2:15 PM
Capricor Therapeutics Announces Positive HOPE-3 Study Results and Regulatory Submission Plans
CAPR
Product Launch
New Projects/Investments
- Capricor Therapeutics' Phase III HOPE-3 study for Deramiocel in Duchenne Muscular Dystrophy (DMD) met its primary efficacy endpoint (Performance of the Upper Limb 2.0) and key secondary endpoints (left ventricular ejection fraction), both achieving statistical significance.
- The company plans to submit a response to the FDA's Complete Response Letter (CRL) with the HOPE-3 data before the end of 2025, with the FDA considering it a Class 2 resubmission, allowing six months for review.
- All Chemistry, Manufacturing, and Controls (CMC) issues from the previous CRL have been addressed and confirmed by the FDA.
- Capricor intends to approach the FDA in the first half of 2026 to discuss a path forward for Deramiocel in Becker muscular dystrophy.
Dec 17, 2025, 6:00 PM
Capricor Therapeutics Presents Positive HOPE-3 Clinical Study Results for Deramiocel in Duchenne Muscular Dystrophy
CAPR
Product Launch
New Projects/Investments
- Capricor Therapeutics announced that its Phase 3 HOPE-3 study for Deramiocel in Duchenne muscular dystrophy (DMD) met its primary efficacy endpoint (Performance of the Upper Limb 2.0) and key secondary endpoint (left ventricular ejection fraction), both achieving statistical significance.
- Deramiocel demonstrated a 54% slowing of upper limb deterioration and a 91% slowing of cardiomyopathy progression in patients.
- The drug maintained a safe and well-tolerated profile, consistent with prior clinical experience.
- Capricor plans to submit a response to the FDA's Complete Response Letter (CRL) with the HOPE-3 data before the end of 2025, with the FDA classifying it as a Class 2 resubmission for a six-month review.
- The company will approach the FDA in the first half of 2026 to discuss a potential path for Deramiocel in Becker muscular dystrophy.
Dec 17, 2025, 6:00 PM
Capricor Therapeutics Announces Positive Phase III Hope III Trial Results for Deramyocel in Duchenne Muscular Dystrophy
CAPR
Product Launch
New Projects/Investments
- Capricor Therapeutics announced positive top-line results from its Phase III Hope III clinical study for Deramyocel in Duchenne muscular dystrophy (DMD).
- The study met its primary efficacy endpoint (Performance of the Upper Limb 2.0) and key secondary endpoint (left ventricular ejection fraction), both achieving statistical significance. Deramyocel demonstrated a 54% slowing of upper limb deterioration and a 91% slowing of cardiac disease progression.
- Deramyocel exhibited a safe and well-tolerated profile, consistent with prior clinical experience.
- Capricor plans to submit its response to the FDA's Complete Response Letter (CRL) with the Hope III data before the end of 2025. The FDA will consider this a Class 2 resubmission, allowing six months for review.
- The company has addressed all manufacturing issues and is ready for commercialization, positioning Deramyocel as a potential first-in-class therapy for DMD skeletal and cardiomyopathy.
Dec 17, 2025, 6:00 PM
Capricor Therapeutics Prices $150 Million Public Offering of Common Stock
CAPR
New Projects/Investments
- Capricor Therapeutics, Inc. announced the pricing of an underwritten public offering of 6,000,000 shares of common stock at $25.00 per share.
- The offering is expected to generate $150 million in gross proceeds before deducting underwriting discounts and commissions.
- The company granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock.
- The net proceeds from the offering are intended for the continued development and manufacturing of its product candidates, working capital, and general corporate purposes.
- The offering is anticipated to close on or about December 8, 2025.
Dec 5, 2025, 10:07 PM
Capricor Reports Positive HOPE-3 Data and Discusses Regulatory Path for Deramiocel
CAPR
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Capricor reported positive Phase 3 HOPE-3 data for deramiocel in treating cardiomyopathy caused by Duchenne muscular dystrophy (DMD), achieving statistical significance for both the primary efficacy endpoint (Performance of the Upper Limb 2.0 with a p-value of 0.03) and the key secondary endpoint (left ventricular ejection fraction with a p-value of 0.04).
- The company plans to respond to the FDA's Complete Response Letter (CRL) before the end of 2025, anticipating PDUFA by the middle of the third quarter (July) for full approval of deramiocel.
- Under its partnership with Nippon Shinyaku, Capricor expects an $80 million milestone payment upon U.S. approval and royalties between 30%-50% on sales.
- Capricor's new commercial manufacturing facility in San Diego can initially meet demand for 500 patients, with plans to expand to 2,500 patients annually. The company projects a cash runway of two to three years with an expected $225 million injection from the milestone payment and potential PRV sale.
- Capricor intends to approach the FDA in the first half of 2026 to seek accelerated approval for deramiocel in Becker's muscular dystrophy, particularly for its cardiomyopathy aspect.
Dec 3, 2025, 4:30 PM
Capricor Reports Positive HOPE-3 Data for Deramiocel in DMD, Plans FDA Resubmission
CAPR
Product Launch
Guidance Update
New Projects/Investments
- Capricor reported positive Phase III HOPE-3 data for deramiocel in Duchenne muscular dystrophy (DMD), achieving statistical significance on the primary efficacy endpoint (Performance of the Upper Limb 2.0) with a p-value of 0.03 and a key secondary endpoint (left ventricular ejection fraction) with a p-value of 0.04.
- The company intends to use this data to respond to the FDA's Complete Response Letter (CRL) by the end of 2025, targeting full approval with an anticipated PDUFA date by mid-Q3 2026.
- Upon approval, Capricor expects an $80 million milestone payment from its partnership with Nippon Shinyaku, along with sales royalties ranging from 30% to 50%.
- Manufacturing capabilities include a San Diego facility ready to meet demand for 500 patients initially, with expansion plans to service 2,500 patients annually.
- Capricor ended Q3 with just under $100 million in cash and anticipates a two to three-year cash runway from the milestone payment and potential sale of a Priority Review Voucher (PRV).
Dec 3, 2025, 4:30 PM
Capricor Reports Positive HOPE-3 Data for Deramiocel in DMD
CAPR
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Capricor's shares increased by approximately 300% on December 3, 2025, following the announcement of positive Phase 3 HOPE-3 data for deramiocel in Duchenne muscular dystrophy (DMD).
- The HOPE-3 trial achieved its primary efficacy endpoint, Performance of the Upper Limb 2.0 (p=0.03), and a key secondary endpoint, left ventricular ejection fraction (p=0.04), providing statistically significant results for both skeletal muscle and cardiac function.
- These data will be used to address the FDA's Complete Response Letter (CRL) by the end of 2025, with an anticipated PDUFA date for full approval by mid-Q3 2026.
- Upon U.S. approval, Capricor is set to receive an $80 million milestone payment from Nippon Shinyaku, with royalties between 30%-50% on sales.
- The company has commercial-scale manufacturing ready in San Diego, capable of serving 500 patients initially and expanding to 2,500 patients annually, and anticipates a cash runway of two to three years from an expected $225 million injection from milestones and a potential Priority Review Voucher (PRV) sale.
Dec 3, 2025, 4:30 PM
Capricor Therapeutics Announces Positive Top-Line Results from HOPE-3 Phase 3 Study
CAPR
Product Launch
New Projects/Investments
- Capricor Therapeutics, Inc. reported positive top-line results from its pivotal Phase 3 HOPE-3 study for Deramiocel, indicating the study met its primary endpoint (PUL v2.0) and key secondary cardiac endpoint (LVEF) with statistical significance (p=0.03 and p=0.04 respectively).
- Deramiocel, a potential first-in-class therapy for Duchenne muscular dystrophy (DMD) skeletal and cardiomyopathy, also demonstrated a favorable safety and tolerability profile consistent with prior clinical experience.
- The company plans to submit a response to the Complete Response Letter to the FDA, incorporating the new HOPE-3 data.
Dec 3, 2025, 2:29 PM
Capricor Announces Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy
CAPR
Product Launch
New Projects/Investments
- Capricor's HOPE-3 phase III pivotal clinical trial of deramiocel for Duchenne muscular dystrophy (DMD) achieved statistically significant improvements in both skeletal and cardiomyopathy.
- The primary efficacy endpoint, Performance of the Upper Limb 2.0 (PUL 2.0) at month 12, demonstrated a 54% slowing of disease (1.2-point absolute change) with a p-value of 0.029.
- The key secondary endpoint, Left Ventricular Ejection Fraction (LVEF), showed a 91% slowing of disease with a p-value of 0.041, and a statistically significant reduction in cardiac scar (late gadolinium enhancement) with a p-value of 0.02.
- Capricor plans to submit this data in response to a prior Complete Response Letter (CRL) from the FDA, with a conservative estimate for a PDUFA date in July following a Class 2 resubmission.
- Deramiocel is positioned as a first-in-class therapy for both Duchenne cardiomyopathy and skeletal muscle myopathy, supported by a consistent safety and tolerability profile.
Dec 3, 2025, 1:00 PM
Quarterly earnings call transcripts for CAPRICOR THERAPEUTICS.
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