Investing.com -- The Food and Drug Administration extended the review period for Capricor Therapeutics' deramiocel application to November 22, 2026, from August 22, the company announced Monday.

The three-month extension follows Capricor's submission of a major amendment to its biologics license application. The amendment contains 24-month data from the HOPE-3 open-label extension study and additional analyses supporting a revised proposed indication that focuses on upper limb function, which served as the primary endpoint in HOPE-3.

The Center for Biologics Evaluation and Research accepted the amendment for review and designated it as a major amendment, which led to the extended timeline to allow more time for assessment of the new data.

The extension aligns with the regulatory approach Capricor outlined earlier this month, when the company said the FDA agreed to review the additional data and extend the target action date.

HC Wainwright maintained its Neutral rating on Capricor. The firm stated it continues to view the regulatory risk as high after a 9-3 negative vote by an advisory committee. The firm said it plans to reassess its position on Capricor after receiving more regulatory information about the deramiocel application.

The firm noted the main question is whether the 24-month HOPE-3 extension data and additional analyses will be enough to address FDA concerns and support approval for the refined indication focused on upper limb function.