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Capricor expressed confidence that the facility will meet the necessary requirements to support product licensure and commercial launch, pending approval.
Shares of Capricor Therapeutics (CAPR) were in the spotlight on Wednesday morning after the company announced the completion of the U.S. Food and Drug Administration’s (FDA) Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel.
Deramiocel is the company’s lead cell therapy candidate. It is under FDA review for potential approval in the treatment of Duchenne Muscular Dystrophy (DMD), a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles.
No material changes are required to the manufacturing process or the facility following the inspection, the company said.
While the FDA made observations, they were primarily related to routine quality systems and documentation practices, it added.
Capricor expressed confidence that the facility will meet the necessary requirements to support product licensure and commercial launch, pending approval.
Capricor is now looking to present evidence in support of an approval for Deramiocel in an upcoming advisory committee meeting. While the FDA has expressed intent to hold the meeting on July 30, it is yet to be confirmed by the agency, Capricor said.
Last month, the company announced after a mid-cycle review meeting that the FDA is on track to decide on its application by the end of August, the deadline. No significant issues or major deficiencies were noted at the time of the mid-cycle review.
A late-cycle meeting is also planned for mid-July.
On Stocktwits, retail sentiment around Capricor stayed unchanged within the ‘bullish’ territory over the past 24 hours while message volume remained ‘high’.
A Stocktwits user expressed optimism about Deramiocel, opining that the technology has “unimaginable potential.”
CAPR stock is down by about 10% this year but up by about 143% over the past 12 months.
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