FDA raised concerns over cell therapy evidence for Capricor Therapeutics, causing a sharp drop in stock price.
5 reports, 3 independent
Updated Aug 27
Gone quiet
- Reports
- 5
- Developments
- 3
- Repetition
- 40%
New informationRepeats or wire copies
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What happened
FDA raised concerns over cell therapy evidence for Capricor Therapeutics, causing a sharp drop in stock price.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Capricor Therapeutics faces FDA rejection and begins regulatory talks in Europe.1 source
Adverse committee vote and FDA briefing documents led to Capricor's share collapse.1 source
FDA concerns over cell therapy evidence led to Capricor stock falling 67%.1 source
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The entities involved
Related events
- ADC Therapeutics is seeking accelerated approval from the FDA for its Zynlonta therapy.
- FDA placed a clinical hold on RGX-121 trials, leading to a sharp decline in REGENXBIO Inc.'s stock price.
- Cardiol Therapeutics Inc. is listed on Nasdaq and is developing therapy for an FDA-approved indication.
- Decoy Therapeutics is listed on the Nasdaq stock exchange and is currently seeking expedited regulatory approval via FDA pathways.
- Argenex SE and Capricor Therapeutics were listed on the Nasdaq stock exchange and are competing in the biotech sector.
Coverage
Newest first; wire copies grouped- yahoo.com
- prnewswire.com
- prnewswire.com
- proactiveinvestors.comCapricor Therapeutics shares tumble after FDA reviewers raise concerns over Duchenne therapy