Capricor Therapeutics, Inc. - Common Stock (CAPR)

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The company is currently running another study with results due in the third quarter.

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FDA rejected Capricor's BLA for Deramiocel due to insufficient evidence, requesting more clinical data to support approval for Duchenne therapy.

The FDA told Capricor in a letter that it is unable to approve its application for Deramiocel in its current form as it does not meet the requirement for substantial evidence of effectiveness and expressed the need for additional clinical data.

The US market session of Friday has yet to be opened, let's have a look at the top gainers and losers in the pre-market session today.

Levi Strauss & Co. (NYSE: LEVI) stock rose as Q2 results beat expectations and full-year guidance was raised. Other gainers and losers noted.

The company flagged that 10 of 13 patients in two dosing cohorts received a compromised batch of briquilimab, leading to muted results.

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

The FDA has indicated that an advisory committee meeting is not required at this time, the company said, while adding that its application for Deramiocel approval remains under priority review.

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel uncertainty.

Capricor shares four-year data showing Deramiocel slowed DMD progression and preserved function, with maintained safety in long-term use.

Stay up-to-date with the latest market trends one hour before the close of the markets on Friday. Explore the top gainers and losers during today's session in our detailed report.

Capricor on Friday announced positive four-year safety and efficacy results from its ongoing mid-stage study of its cell therapy Deramiocel, which failed to cheer investors.

The session on Friday is off to an intriguing start with several stocks showing significant price gaps. Let's examine the gap up and gap down stocks in today's session.

Capricor expressed confidence that the facility will meet the necessary requirements to support product licensure and commercial launch, pending approval.