Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
Capricor Therapeutics shares have plunged after FDA staff raised concerns regarding the efficacy and data of its Duchenne heart disease therapy.
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The brief
The FDA is questioning the efficacy and data associated with Capricor's therapy for Duchenne heart disease. These concerns were flagged by FDA staff ahead of a scheduled hearing.
Coverage from Reuters, STAT, and WTVB emphasizes the FDA's flags on the drug's efficacy. Following these reports, Reuters notes that company shares have plunged, while Yahoo Finance discusses whether the stock is now trading at a discount.
Attention remains on the upcoming hearing. Additionally, MarketBeat reports that stock traders have purchased a large volume of call options on Capricor Therapeutics (NASDAQ:CAPR).
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Quick answers
What is the FDA's primary concern regarding Capricor?
FDA staff have flagged concerns regarding the efficacy and data of the company's Duchenne heart disease therapy.
How has the market reacted to the FDA news?
Shares of Capricor Therapeutics have plunged, though MarketBeat reports a large volume of call options have been purchased by traders.
When did these concerns emerge?
The concerns were raised ahead of a scheduled hearing.
Coverage (10)
- FDA scientists question Capricor data; Legend CEO steps down BioPharma Dive · 3h ago
- Capricor Therapeutics Provides Update Ahead of FDA Advisory Committee Meeting on Deramiocel BLA for Duchenne Muscular Dystrophy Quiver Quantitative · 3h ago
- How FDA‑Linked HQ and Manufacturing Expansion At Capricor Therapeutics (CAPR) Has Changed Its Investment Story Yahoo Finance · 3h ago
- Capricor updates ahead of FDA advisory meeting on Duchenne muscular dystrophy therapy Deramiocel. Pluang · 3h ago
- Capricor Therapeutics (CAPR) Secures New Headquarters Tied To FDA Decision On Deramiocel simplywall.st · 3h ago
- FDA staff flags concerns for Capricor’s Duchenne heart disease therapy WTVB · 3h ago
- Stock Traders Purchase Large Volume of Call Options on Capricor Therapeutics (NASDAQ:CAPR) MarketBeat · 3h ago
- FDA staff flags data concerns about Capricor's therapy; shares plunge Reuters · 3h ago
- Is Capricor Therapeutics (CAPR) Trading At A Discount After Its Lease Deal And FDA Wait? Yahoo Finance · 3h ago
- Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug STAT · 3h ago broke it first
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