Capricor Therapeutics is seeking FDA approval for its deramiocel cell therapy, with announcements made at biotech events and trading on the electronic stock exchange.
11 reports, 6 independent
Updated Sep 11
Gone quiet
- Reports
- 11
- Developments
- 4
- Repetition
- 73%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
Capricor Therapeutics is seeking FDA approval for its deramiocel cell therapy, with announcements made at biotech events and trading on the electronic stock exchange.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- FDA documents challenged Capricor's claims while the company remains listed on Nasdaq.Sub-event
Capricor stock is listed on Nasdaq, and the FDA reviewed efficacy data for Deramiocel.1 source
Capricor Therapeutics seeks FDA approval for cell therapy; trading and biotech announcements made.1 source
FDA issued a Complete Response Letter on the BLA submission for Capricor Therapeutics.1 source
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The entities involved
- FDA
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Goldman Sachs
American investment bank
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Nasdaq
American fully electronic stock exchange
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Capricor Therapeutics (United States)
company in Beverly Hills, United States
Nothing else this week.
Related events
Coverage
Newest first; wire copies grouped- gazettextra.com
- biopharmadive.com
- prnewswire.com
- prnewswire.com
- benzinga.comCapricor Therapeutics Shares Dive Before Key Review as FDA Panel Challenges Data - Capricor Therapeutics
- yahoo.com
- GlobeNewswireCapricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongo