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Capricor Therapeutics filings document a Delaware biotechnology issuer developing cell and exosome-based therapeutics, including Deramiocel for Duchenne muscular dystrophy. Its 8-K reports record quarterly and annual financial results, FDA communications tied to the Deramiocel Biologics License Application, Regulation FD disclosures, and material-event reporting for litigation-related actions.
Proxy materials address board elections, executive compensation, equity awards, shareholder voting matters, and other governance disclosures. The filing record also identifies CAPR common stock, par value $0.001 per share, as a Nasdaq-listed security and provides formal disclosure around operating results, capital structure, and public-company status.
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, Inc. (CAPR) is the subject of a Schedule 13G reporting the equity position of Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander in Capricor’s common stock. The reporting persons disclose beneficial ownership of 2,857,387 Capricor shares, representing 4.9% of the outstanding common stock, with no sole voting or dispositive power and full holdings under shared voting and shared dispositive power.
The group states that it acquired more than 5% of Capricor’s outstanding common stock on August 17, 2026, but by the date of this report its beneficial ownership had fallen to 5% or less. The filing explains that the securities are held by entities over which Millennium-related managers have voting control and investment discretion, and it disclaims that this structure alone constitutes an admission of beneficial ownership.
Capricor Therapeutics, Inc. reported no revenue for the three and six months ended June 30, 2026, while significantly increasing investment in its Duchenne muscular dystrophy programs. Research and development expenses rose to $56.2 million for the first half of 2026, and general and administrative expenses to $23.5 million, leading to a six‑month net loss of $74.7 million versus $50.3 million a year earlier.
Cash, cash equivalents and marketable securities totaled $237.9 million at June 30, 2026, down from $318.1 million at year‑end, reflecting operating cash use of $60.7 million and heavy investment in marketable securities and manufacturing and facility build‑out. The company recorded operating lease right‑of‑use assets of $88.6 million and lease liabilities of $91.0 million, driven by a long‑term San Diego headquarters and manufacturing lease. Capricor fully repaid a $6.3 million CIRM loan and continues to defer the $12.0 million Japan distribution upfront payment as deferred revenue pending future performance obligations.
Tang Capital Management, LLC and affiliated entities, together with Kevin Tang, report beneficial ownership of 4,099,900 shares of Capricor Therapeutics, Inc. common stock on an amended Schedule 13G. This represents 7.1% of the outstanding common stock, based on 57,911,893 shares outstanding as of May 11, 2026.
The group reports no sole voting or dispositive power and shared voting and dispositive power over all 4,099,900 shares. Tang Capital Partners, LP, Tang Capital Partners International, LP, Tang Capital Partners III, Inc., and Tang Capital Partners IV, Inc. each hold portions of these shares, with Kevin Tang and Tang Capital Management sharing voting and dispositive authority as described.
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.
State Street Corporation has filed a Schedule 13G reporting beneficial ownership of common stock of Capricor Therapeutics Inc. State Street reports beneficial ownership of 3,397,241 shares of Capricor common stock, representing 5.9% of the class.
State Street reports 0 shares with sole voting and dispositive power and 3,285,634 shares with shared voting power. It also reports 3,397,241 shares with shared dispositive power, reflecting holdings managed through affiliated investment and advisory subsidiaries listed in the filing.
RA Capital Healthcare Fund, L.P., advised by RA Capital Management, L.P., reports beneficial ownership of 3,014,183 shares of Capricor Therapeutics, Inc. common stock. This represents 5.2% of the outstanding shares, based on 57,911,893 shares outstanding as of May 11, 2026.
RA Capital has been delegated sole power to vote and dispose of the Fund’s Capricor shares, but the Fund disclaims beneficial ownership because it has divested voting and investment power and cannot revoke this delegation on less than 61 days’ notice. RA Capital, Peter Kolchinsky, and Rajeev Shah may be deemed beneficial owners for Section 13(d) purposes, but each disclaims beneficial ownership except for determining reporting obligations.
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.