Capricor Therapeutics Completes Enrollment in Phase 3 DMD Trial

TL;DR

Capricor just finished enrolling patients in its big DMD drug trial. Big step forward.

AI Summary

On October 9, 2024, Capricor Therapeutics, Inc. filed an 8-K to report on the status of its lead product candidate, CAP-1002. The company announced that it has completed enrollment in its Phase 3 trial for Duchenne muscular dystrophy (DMD). This trial is a pivotal study for CAP-1002, and the completion of enrollment is a significant milestone.

Why It Matters

The completion of enrollment in the Phase 3 trial is a critical step towards potentially gaining regulatory approval for CAP-1002, which could offer a new treatment option for patients with Duchenne muscular dystrophy.

Risk Assessment

Risk Level: medium — While trial enrollment completion is positive, the ultimate success and regulatory approval of CAP-1002 are still uncertain.

Key Players & Entities

• Capricor Therapeutics, Inc. (company) — Registrant
• CAP-1002 (drug) — Lead product candidate
• Duchenne muscular dystrophy (DMD) (disease) — Indication for CAP-1002
• October 9, 2024 (date) — Filing date

FAQ

Key Financial Figures

• $0.001 — h Registered Common Stock, par value $0.001 per share CAPR The Nasdaq Capital M

Filing Documents

• capr-20241009x8k.htm (8-K) — 39KB
• capr-20241009xex99d1.htm (EX-99.1) — 15KB
• capr-20241009xex99d1001.jpg (GRAPHIC) — 5KB
• 0001558370-24-013207.txt ( ) — 181KB
• capr-20241009.xsd (EX-101.SCH) — 3KB
• capr-20241009_lab.xml (EX-101.LAB) — 15KB
• capr-20241009_pre.xml (EX-101.PRE) — 9KB
• capr-20241009x8k_htm.xml (XML) — 5KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On October 9, 2024, Capricor Therapeutics, Inc. (the "Company" or "Capricor") issued a press release announcing that it has initiated its rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA), seeking full approval for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. A copy of the press release has been filed as Exhibit 99.1 hereto and is incorporated herein by reference. The information under Item 7.01 of this Current Report on Form 8-K, Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company's filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing.

01. Other Events

Item 8.01. Other Events. On October 9, 2024, Capricor announced that it had initiated its rolling submission process with the FDA for a BLA, seeking full approval for deramiocel to treat all patients diagnosed with DMD cardiomyopathy. The Company plans to complete its rolling BLA submission by the end of 2024.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release, titled "Capricor Therapeutics Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy", dated October 9, 2024 . 104 Cover Page Interactive Data File (formatted as inline XBRL). 2

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. CAPRICOR THERAPEUTICS, INC. Date: October 9, 2024 By: /s/ Linda Marbn, Ph.D. Linda Marbn, Ph.D. Chief Executive Officer 3

View Full Filing

View this 8-K filing on SEC EDGAR