Every 8-K that Capricor Therapeutics Inc (CAPR) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CAPR and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CAPR filings page.
Capricor Therapeutics, Inc. (CAPR) reported that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy, from August 22, 2026 to November 22, 2026. The FDA classified Capricor’s recent submission as a major amendment, adding three months to the review to assess 24‑month open-label extension data from the pivotal Phase 3 HOPE‑3 study and additional robustness analyses. Capricor is asking the FDA to consider a refined proposed indication focused on upper limb function, the HOPE‑3 primary endpoint, which the company states was met with a statistically significant benefit. Deramiocel holds multiple U.S. and EU regulatory designations for DMD, including Orphan Drug, RMAT and Rare Pediatric Disease, which may allow a Priority Review Voucher if approved.
Capricor Therapeutics reported second quarter 2026 results, highlighting continued investment in late-stage development of its lead Duchenne muscular dystrophy cell therapy, Deramiocel, and its exosome platform. For the quarter ended June 30, 2026, the company generated no revenue while recording significantly higher operating expenses.
Research and development expenses were $28.9 million, up from $22.0 million a year earlier, and general and administrative expenses were $14.1 million versus $5.7 million, bringing total operating expenses to $42.9 million. Net loss for the quarter widened to $40.7 million, compared with $25.9 million in the prior-year quarter, or $(0.70) per share versus $(0.57).
As of June 30, 2026, Capricor held $237.9 million in cash, cash equivalents and marketable securities, down from $318.1 million at December 31, 2025. Total assets were $368.7 million, total liabilities $122.5 million, and stockholders’ equity $246.2 million with about 58.1 million shares outstanding. Management reiterated its focus on advancing Deramiocel toward potential approval and emphasized ongoing regulatory interactions.
Capricor Therapeutics stated that the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support the effectiveness of its lead cell therapy, Deramiocel, for treating cardiomyopathy in patients with Duchenne muscular dystrophy; the vote was 3 in favor, 9 against and 0 abstentions.
The recommendation is non-binding, and the FDA continues its review of Capricor’s Biologics License Application for Deramiocel, with the Prescription Drug User Fee Act target action date remaining August 22, 2026. The company noted that the committee’s voting question covered a narrower indication than it originally proposed and did not address Deramiocel’s overall benefit‑risk profile. In a separate discussion on upper limb function, committee feedback was described as directionally supportive of Phase 3 HOPE‑3 trial data, including on the primary endpoint PUL 2.0, and Capricor indicated it remains focused on working with the FDA toward potential approval.
Capricor Therapeutics announced that The Lancet has published the final one-year results from its Phase 3 HOPE-3 trial of Deramiocel in Duchenne muscular dystrophy, based on Statistical Analysis Plan 3.0. The randomized, double-blind, placebo-controlled study (n=106) met its primary endpoint, with Deramiocel slowing upper limb function decline by 54 percent versus placebo on PUL 2.0 (p=0.03). Deramiocel’s Biologics License Application for DMD remains under active FDA review, with a PDUFA target action date of August 22, 2026.
In dialogue with FDA and peer reviewers, Capricor updated the statistical model for left ventricular ejection fraction, yielding p=0.09 and a 1.8 percentage point treatment difference, versus p=0.04 and 2.4 points previously, while a pre-specified cardiomyopathy subgroup remained nominally significant at p=0.02. An FDA Bioresearch Monitoring inspection of HOPE-3 operations resulted in a Form FDA 483 citing one observation tied to procedures, documentation, vendor oversight and audit timeliness; the company stated it does not believe this affects HOPE-3 data integrity and plans a complete, timely response.
Capricor Therapeutics entered into a long-term Lease Agreement with ARE-SD Region No. 39 Owner, LLC for approximately 171,000 rentable square feet at 9625 Towne Centre Drive in San Diego, to serve as its new headquarters with expanded manufacturing cleanrooms, research and development laboratories and administrative offices.
The lease term is estimated to begin on the earlier of satisfaction or waiver of an FDA-approval-related lease contingency or December 31, 2026, with rent starting 12 months later and continuing for 138 months. Initial monthly base rent is $5.60 per rentable square foot, or approximately $958,000 per month, subject to 3.0% annual increases.
Capricor will receive an 18-month full base rent abatement from the rent commencement date, followed by six months of partial abatement during which rent is due on 128,068 square feet before applying to the full premises. The landlord will provide a tenant improvement allowance, while Capricor must post a security deposit of approximately $958,000 and pay property taxes, insurance, maintenance and operating costs. If FDA approval of Deramiocel for Duchenne muscular dystrophy is not obtained by December 31, 2026, either party may terminate the lease within five business days.
Capricor Therapeutics filed an 8-K announcing that the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee will review its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
The advisory committee meeting is scheduled for July 29, 2026 and will be live streamed. The BLA is supported by positive Phase 2 and long-term HOPE-2 data and the Phase 3 HOPE-3 trial, which achieved statistical significance on its primary functional endpoint and key cardiac and other controlled secondary endpoints. The application remains on track with a PDUFA target action date of August 22, 2026. Deramiocel has multiple regulatory designations, including Orphan Drug and RMAT, and could qualify Capricor for a Priority Review Voucher upon approval.
Capricor Therapeutics, Inc. reported the results of its Annual Meeting of stockholders held at its San Diego headquarters on June 4, 2026. Holders of 43,823,881 shares were present in person or by proxy, out of 57,840,102 common shares entitled to vote.
Eight director nominees each received more votes "For" than "Withheld", including Linda Marbán, Ph.D. with 25,482,880 For and 5,310,512 Withheld. One proposal received 43,057,620 votes For, 562,751 Against and 203,510 Abstain, while another received 24,336,434 For, 6,244,316 Against, 212,642 Abstain and 13,030,489 broker non-votes.
A proposal offering choices of one, two, or three years received 29,774,194 votes for one year, 418,808 for two years, 189,009 for three years, and 411,381 Abstain, with 13,030,489 broker non-votes. Another proposal received 23,472,207 For, 6,433,198 Against, 887,987 Abstain and 13,030,489 broker non-votes.
Capricor Therapeutics reported first quarter 2026 results with a net loss of $33.9 million, compared with $24.4 million a year earlier, as it continues late-stage development of Deramiocel for Duchenne muscular dystrophy. Revenue was $0 for both periods, reflecting the company’s pre-commercial stage.
Research and development expenses increased to $27.4 million from $18.9 million, while general and administrative costs rose to $9.4 million from $6.1 million. Investment income grew to $2.9 million, partially offsetting operating losses. Cash, cash equivalents and marketable securities totaled $278.6 million as of March 31, 2026, down from $318.1 million at December 31, 2025.
Management highlighted ongoing FDA review of its Biologics License Application for Deramiocel, with a PDUFA target action date of August 22, 2026, and noted recent legal action involving NS Pharma related to commercialization arrangements and patient access.
Capricor Therapeutics reported fourth-quarter and full-year 2025 results alongside a corporate update centered on its lead DMD therapy, Deramiocel. The company’s Biologics License Application is under FDA review with a PDUFA target action date of August 22, 2026.
Cash, cash equivalents and marketable securities were about $318.1 million as of December 31, 2025, up from about $151.5 million a year earlier, driven by a public offering that generated roughly $161.9 million in net proceeds and $75.1 million raised via its at-the-market program.
Revenues were $0 in both the fourth quarter and full year 2025, versus about $11.1 million and $22.3 million in 2024, after fully recognizing prior milestone payments from Nippon Shinyaku by year-end 2024. Total operating expenses rose to about $108.1 million for 2025, leading to a net loss of roughly $105.0 million, or $2.26 per share. Management believes its current cash position can fund operations through 2027 while it advances Deramiocel and its exosome platform.
Capricor Therapeutics, Inc. reported that the U.S. FDA has lifted a prior Complete Response Letter and resumed review of its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy. The resubmission is classified as Class 2, with a PDUFA target action date of August 22, 2026.
The company submitted additional data and documentation from the HOPE-3 clinical trial, and the FDA has not identified any potential review issues in its response. Capricor also expects to be eligible to receive a Priority Review Voucher if Deramiocel is approved.
Capricor Therapeutics (CAPR) furnished an 8‑K announcing it issued a press release with financial results for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1.
The information under Item 2.02 and Exhibit 99.1 is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, nor incorporated by reference into other filings unless expressly stated.
Capricor Therapeutics furnished a press release announcing its financial results for the quarter ended June 30, 2025; the press release is attached as Exhibit 99.1. The company states the release is being furnished, not filed, and therefore is not subject to Section 18 liability and will not be incorporated by reference into other Exchange Act filings unless expressly stated. The filing also includes a Cover Page Interactive Data File (inline XBRL) as Exhibit 104. The report identifies Capricor common stock trading as CAPR on The Nasdaq Capital Market and is signed by CEO Linda Marbán, Ph.D.. Investors should review Exhibit 99.1 for the detailed financial figures because the 8-K text here provides only the notice of the release.