Capricor Therapeutics to Discuss Deramiocel BLA with FDA.
PorAinvest
viernes, 8 de agosto de 2025, 8:36 am ET1 min de lectura
CAPR--
The meeting, scheduled for August 11, 2025, will discuss the regulatory pathway for Capricor's Biologics License Application (BLA) for Deramiocel, the company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1]. This meeting indicates potential regulatory hurdles and is a significant development in the company's efforts to bring Deramiocel to market.
The rescheduling of the financial results release to August 11, 2025, after the market close, allows management to incorporate the outcomes of the FDA meeting into their investor communications. The company will host a webcast and conference call at 4:30 p.m. ET on the same day [1].
Deramiocel, currently in late-stage development, has shown promising immunomodulatory and anti-fibrotic properties in preserving cardiac and skeletal muscle function in DMD patients. The company has an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the US and Japan [1].
The outcome of the Type A meeting will determine whether additional data is required, if there are manufacturing concerns, or if the clinical endpoints achieved are sufficient for approval. This meeting signals potential regulatory issues that could impact the timeline to potential market approval for Deramiocel.
References:
[1] https://www.stocktitan.net/news/CAPR/capricor-therapeutics-announces-type-a-meeting-scheduled-with-u-s-xgqz212d23sz.html
• Capricor Therapeutics to discuss Deramiocel BLA with FDA at Type A meeting. • Company reschedules Q2 2025 financial results release to Aug. 11, 2025. • Management to host webcast and conference call on Aug. 11, 2025 at 4:30 p.m. ET. • Deramiocel is a cell therapy candidate for cardiomyopathy associated with Duchenne muscular dystrophy.
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on cell and exosome-based therapeutics for rare diseases, has announced the rescheduling of its Q2 2025 financial results release to August 11, 2025, following a Type A meeting with the U.S. Food and Drug Administration (FDA) [1].The meeting, scheduled for August 11, 2025, will discuss the regulatory pathway for Capricor's Biologics License Application (BLA) for Deramiocel, the company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1]. This meeting indicates potential regulatory hurdles and is a significant development in the company's efforts to bring Deramiocel to market.
The rescheduling of the financial results release to August 11, 2025, after the market close, allows management to incorporate the outcomes of the FDA meeting into their investor communications. The company will host a webcast and conference call at 4:30 p.m. ET on the same day [1].
Deramiocel, currently in late-stage development, has shown promising immunomodulatory and anti-fibrotic properties in preserving cardiac and skeletal muscle function in DMD patients. The company has an exclusive commercialization agreement with Nippon Shinyaku Co., Ltd. for Deramiocel in the US and Japan [1].
The outcome of the Type A meeting will determine whether additional data is required, if there are manufacturing concerns, or if the clinical endpoints achieved are sufficient for approval. This meeting signals potential regulatory issues that could impact the timeline to potential market approval for Deramiocel.
References:
[1] https://www.stocktitan.net/news/CAPR/capricor-therapeutics-announces-type-a-meeting-scheduled-with-u-s-xgqz212d23sz.html
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