Capricor Therapeutics Receives Critical FDA Clarity for Key Drug Candidate

Investors showed renewed confidence in Capricor Therapeutics last week following a significant regulatory development from the U.S. Food and Drug Administration. The agency provided crucial guidance regarding the Biologics License Application for the company’s lead therapy, Deramiocel, sending shares substantially higher.

The positive sentiment translated into immediate gains for Capricor’s stock, which climbed between 7% and 9% during early trading sessions. By Friday’s close, shares had reached $7.09, representing a notable single-day advance of 8.74%. This upward movement marks a significant recovery from the substantial declines experienced after the company received a Complete Response Letter from regulators in July.

Regulatory Pathway Becomes Clearer

In a pivotal decision, the FDA has agreed to accept data from the... Read more...