Edward Tenthoff

Kristen Kluska

Leland Gershell

Aydin Huseynov

Catherine Novack

Joseph Pantginis

Boobalan Pachaiyappan

Bubalan Pachayapan

Chris Lemos

Ivan Hosinov

Madison El-Saadi

Madison Wynne El-Saadi

Matthew Venezia

- Capricor Therapeutics received a positive outcome from a Type A meeting with the FDA regarding its Duchenne Muscular Dystrophy (DMD) program.  **[1133869_2157397_1]** 
- The FDA agreed to accept and review data from the **HOPE-three pivotal trial** as part of the ongoing Biologics License Application (BLA), with **top-line data expected in mid-November 2025**.  **[1133869_2157397_1]** 
- The FDA will allow the BLA to remain open and consider both skeletal muscle and cardiac muscle endpoints, creating **two potential labeling opportunities** for deromyosil.  **[1133869_2157397_2]** 
- The company has **more than $120 million in cash and equivalents**, which is expected to fund operations well into **2026** and support launch readiness.  **[1133869_2157397_2]**

Capricor Therapeutics Provides Positive Regulatory Update for DMD Program

- Faruqi & Faruqi is reminding Capricor Therapeutics investors of a pending **securities class action lawsuit** with a lead plaintiff deadline of **September 15, 2025**.  **[1133869_2e5ea493541c43f995eb52b8c081dad2_0]** 
- The lawsuit alleges Capricor made false or misleading statements and/or concealed material adverse facts regarding its lead cell therapy candidate drug, **deramiocel**, specifically concerning its ability to obtain a Biologics License Application (BLA) from the FDA.  **[1133869_2e5ea493541c43f995eb52b8c081dad2_0]** 
- This action follows the FDA's issuance of a **Complete Response Letter (CRL)** on **July 11, 2025**, denying the deramiocel BLA due to insufficient evidence of effectiveness and the need for additional clinical data.  **[1133869_2e5ea493541c43f995eb52b8c081dad2_0]** 
- Following the CRL announcement, Capricor's stock price declined from **$11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025**.  **[1133869_2e5ea493541c43f995eb52b8c081dad2_0]** **[1133869_2e5ea493541c43f995eb52b8c081dad2_1]**

Faruqi & Faruqi Reminds Capricor Investors of Class Action Deadline

- A class action securities lawsuit has been filed against **Capricor Therapeutics, Inc. (CAPR)**, alleging securities fraud.  **[1133869_32e684a24afc4603abb8858b4a750a26_0]** 
- The lawsuit covers investors who were adversely affected between **October 9, 2024**, and **July 10, 2025**.  **[1133869_32e684a24afc4603abb8858b4a750a26_0]** 
- The complaint alleges that defendants provided misleading statements concerning Capricor’s lead cell therapy candidate, deramiocel, and its ability to obtain a Biologics License Application (BLA) from the FDA.  **[1133869_32e684a24afc4603abb8858b4a750a26_0]** 
- This follows the FDA's denial of the BLA on **July 11, 2025**, citing a lack of substantial evidence of effectiveness and the need for additional clinical data, which caused Capricor's stock price to decline from **$11.40** to **$7.64** per share.  **[1133869_32e684a24afc4603abb8858b4a750a26_0]** 
- Investors have until **September 15, 2025**, to request to be appointed as lead plaintiff in the lawsuit.  **[1133869_32e684a24afc4603abb8858b4a750a26_0]**

Capricor Therapeutics Faces Class Action Securities Lawsuit

- **Capricor Therapeutics** is facing a class action lawsuit alleging **false and/or misleading statements** regarding its lead cell therapy candidate drug, deramiocel, and its ability to obtain a Biologics License Application (BLA) from the FDA.  **[1133869_71cee962afc1439ab7f81a037882d1ae_1]** 
- The class period for the lawsuit is **October 9, 2024, to July 10, 2025**, with a deadline of **September 15, 2025**, for investors to petition to serve as lead plaintiff.  **[1133869_71cee962afc1439ab7f81a037882d1ae_1]** 
- The lawsuit follows Capricor's announcement on **July 11, 2025**, that it received a **Complete Response Letter (CRL) from the FDA**, denying the BLA for deramiocel due to insufficient evidence of effectiveness and other issues.  **[1133869_71cee962afc1439ab7f81a037882d1ae_2]** 
- Following the FDA's CRL, Capricor's stock price **declined from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025**.  **[1133869_71cee962afc1439ab7f81a037882d1ae_2]**

Capricor Therapeutics Faces Class Action Lawsuit Over Deramiocel BLA

- Faruqi & Faruqi, LLP is investigating potential claims against **Capricor Therapeutics, Inc. (CAPR)** for alleged false and misleading statements concerning its lead cell therapy candidate drug, deramiocel, for Duchenne muscular dystrophy (DMD).  **[1133869_621c2e2108d4470aa30e4cbe5d859885_1]** 
- The complaint alleges that Capricor made positive statements about obtaining a Biologics License Application (BLA) for deramiocel while concealing adverse facts about its four-year safety and efficacy data from the Phase 2 HOPE-2 trial study.  **[1133869_621c2e2108d4470aa30e4cbe5d859885_1]** 
- On **July 11, 2025**, Capricor announced it received a Complete Response Letter (CRL) from the FDA denying the BLA, citing a lack of substantial evidence of effectiveness and the need for additional clinical data.  **[1133869_621c2e2108d4470aa30e4cbe5d859885_1]** 
- Following this news, Capricor's stock price declined from **$11.40** on July 10, 2025, to **$7.64** on July 11, 2025.  **[1133869_621c2e2108d4470aa30e4cbe5d859885_1]** 
- Investors who suffered losses exceeding **$50,000** between **October 9, 2024, and July 10, 2025**, are encouraged to contact Faruqi & Faruqi, LLP, with a lead plaintiff deadline of **September 15, 2025**.  **[1133869_621c2e2108d4470aa30e4cbe5d859885_0]** **[1133869_621c2e2108d4470aa30e4cbe5d859885_1]**

CAPRICOR THERAPEUTICS (CAPR)