FDA Schedules Advisory Panel for Capricor's Deramiocel BLA on July 29
CAPR has more than doubled off its 52-week low of $4.3 on elevated volume (4.9× avg).
Summary
The FDA has scheduled an advisory committee meeting for Capricor Therapeutics' lead drug, Deramiocel, on July 29. This critical step precedes the August 22 PDUFA target action date, which was confirmed earlier today. The panel's recommendation will be a key indicator for the final FDA approval decision, especially following positive five-year data from the HOPE-2 OLE study announced earlier today. Investors will be focused on the July 29 meeting for insights into the drug's regulatory path.
At the time of this announcement, CAPR was trading at $26.55 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.5B. The 52-week trading range was $4.30 to $40.37. This news item was assessed with neutral market sentiment and an importance score of 8 out of 10. Source: Wiseek News.