---
title: "What's Going On With Capricor Therapeutics Stock On Friday?"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/290997344.md"
description: "Capricor Therapeutics (CAPR) stock fell approximately 13% on Friday after the FDA scheduled a July 29, 2026 advisory committee meeting to discuss its Biologics License Application for Deramiocel, a cell therapy for Duchenne muscular dystrophy. The BLA is supported by positive Phase 2 and Phase 3 trial results. Investors likely reacted negatively to the additional regulatory step required before a final FDA decision."
datetime: "2026-06-26T18:06:40.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/290997344.md)
  - [en](https://longbridge.com/en/news/290997344.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/290997344.md)
---

# What's Going On With Capricor Therapeutics Stock On Friday?

**Capricor Therapeutics Inc.** (NASDAQ:CAPR) stock is trading lower on Friday, down by 13%.

The Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) of the U.S. Food and Drug Administration (FDA) is planning to convene an advisory committee meeting to discuss the company’s Biologics License Application (BLA) seeking approval of Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).

**Read Also: Capricor Therapeutics Says NS Pharma Delays Could Threaten Access To Duchenne Therapy**

## FDA Sets Advisory Committee Meeting For Capricor Deramiocel

The BLA is supported by the Phase 2 HOPE-2 trial and long-term outcomes from the HOPE-2-OLE trial, as well as positive results from the Phase 3 HOPE-3 trial, which achieved statistical significance on its primary endpoint (PUL v2.0), the key secondary cardiac endpoint (LVEF), and all other Type I error-controlled secondary endpoints.

The date for the Advisory Committee meeting is July 29, 2026.

"We are encouraged by the opportunity to bring Deramiocel before the Advisory Committee and engage directly with the FDA, the DMD patient community, and the physicians who care for them," said **Linda Marbán**, CEO of Capricor.

## FDA Reconsiders Multiple Cell And Gene Therapy Applications

Capricor stock is trading lower as investors probably react to the additional step (adcom meeting) for its Duchenne gene therapy before the final FDA decision.

Several controversial decisions marked **Dr. Vinay Prasad’s** tenure at the FDA. After his departure, the agency has started reconsidering some of the decisions.

In May, **Replimune Group Inc**. (NASDAQ:REPL) said that the company and the FDA aligned on a path forward for resubmission and reconsideration of BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma.

Earlier this week, **Regenxbio Inc.** (NASDAQ:RGNX) said it aligned with the FDA regarding the next steps needed for a potential accelerated approval of Navsunli (RGX-121, clemidsogene lanparvovec).

Last week, **uniQure N.V.** (NASDAQ:QURE) announced plans for a BLA submission for AMT-130, a gene therapy treatment for Huntington’s disease.

Last week, **Moderna Inc.** (NASDAQ:MRNA), a key FDA panel voted unanimously in favor of the benefit-risk profile of its experimental seasonal influenza vaccine, clearing a major regulatory hurdle ahead of a final approval decision in August.

**CAPR Price Action:** Capricor Therapeutics shares were down 12.75% at $26.52 at the time of publication on Friday, according to Benzinga Pro data.

_Pavel Kapysh from Shutterstock_

**Read Also: Ulta's Unique Platform Can't Be Easily Replicated: Analyst**

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## Related News & Research

- [Capricor publishes advisory committee presentation on deramiocel clinical data in Duchenne muscular dystrophy](https://longbridge.com/en/news/293953736.md)
- [QUICK SPARK: Capricor Stock Dives — 'Complete Fraud' Says Pharma Bro Martin Shkreli](https://longbridge.com/en/news/293956617.md)
- [Capricor Comments on Briefing Materials Ahead of July 29 FDA Advisory Committee Meeting for Deramiocel | CAPR Stock News](https://longbridge.com/en/news/293951290.md)
- [Capricor disputes FDA post-hoc analyses of deramiocel data ahead of July 29 advisory panel](https://longbridge.com/en/news/293950459.md)
- [Capricor Therapeutics (CAPR) Secures New Headquarters Tied To FDA Decision On Deramiocel](https://longbridge.com/en/news/293853158.md)