---
title: "Capricor’s deramiocel for Duchenne appears headed for FDA rejection"
id: "stat-news-1-stat-capricor-therapeutics-duchenne-treatment-is-heading-for-an-fda-rejection"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-capricor-therapeutics-duchenne-treatment-is-heading-for-an-fda-rejection"
content_type: "clinical_feed_article"
specialty: "Neurology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/08/20/capricor-therapeutics-duchenne-treatment-fda/?utm_campaign=rss"
published_at: "2026-08-20T10:30:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Capricor’s deramiocel for Duchenne appears headed for FDA rejection
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-capricor-therapeutics-duchenne-treatment-is-heading-for-an-fda-rejection
- **Specialty:** [Neurology](https://medichelpline.com/clinical-feed/neurology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/08/20/capricor-therapeutics-duchenne-treatment-fda/?utm_campaign=rss)
- **Published At:** 2026-08-20T10:30:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Capricor Therapeutics has submitted results from an **open-label extension** of its failed **Phase 3** trial of deramiocel to the FDA in an effort to avoid regulatory rejection. - The company publicly expresses confidence in deramiocel despite the Phase 3 failure, but the filing is characterized in the source as a **stall tactic** rather than a substantive path to approval. - According to the reporting, the only remaining route to potential approval would be to run a wholly new, randomized clinical trial; the open-label-extension data are unlikely to substitute for that requirement. - The reporting notes that the rationale for Capricor’s outward confidence is unclear; the story implies skepticism about the clinical or regulatory sufficiency of the new submission. - The article is a STAT+ exclusive by Adam Feuerstein and the full investigative detail is behind a STAT+ paywall; the publicly available story summarizes the company’s submission and the author’s assessment. - The source does not provide detailed efficacy or safety results from the open-label-extension, nor does it report FDA correspondence, specific trial data, or timelines for regulatory decisions. - Key terms in the story include **deramiocel**, **Duchenne muscular dystrophy**, **Phase 3**, and **FDA rejection**; the piece frames the submission as a last-resort maneuver rather than a corrective regulatory strategy. - The report situates the development in the context of drug development and regulatory standards, but specific next steps, data details, or company plans beyond the submission are not reported in the source.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)Opinion[Adam’s Biotech Scorecard](https://www.statnews.com/category/adams-biotech-scorecard/) # Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejection ## Publicly, the company maintains confidence in its drug. It’s not clear why * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * Email this article * [Share this article](https://www.statnews.com/2026/08/20/capricor-therapeutics-duchenne-treatment-fda/?utm_campaign=rss) ![Adam's take main illustration](https://www.statnews.com/wp-content/uploads/2022/06/AdamsTake_Illustration_MollyFerguson_061322-645x645.jpg) Molly Ferguson/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) By [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) Aug. 20, 2026 Senior Writer, Biotech ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) 1. [](https://x.com/adamfeuerstein "X") adam.feuerstein@statnews.com Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast [The Readout Loud](https://www.statnews.com/category/readout-loud/) and author of the newsletter [Adam’s Biotech Scorecard.](https://www.statnews.com/signup/scorecard/) You can reach Adam on Signal at stataf.54. _This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up[here](https://www.statnews.com/signup/scorecard/) to get it delivered to their inbox._ Capricor Therapeutics is trying to stave off the Food and Drug Administration’s near-certain rejection of its cell therapy for Duchenne muscular dystrophy by submitting results from an open-label extension of its failed Phase 3 study. Advertisement It’s a stall tactic. Nothing more. The only option left for Capricor to secure approval of its treatment, called deramiocel, is to conduct an entirely new, randomized clinical trial. 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