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Capricor Stock Rises Despite Wider-Than-Expected Q3 Loss

Dylan Berman 3 hours ago

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Capricor Therapeutics shares are trading higher Wednesday despite a wider-than-expected Q3 loss Tuesday after the market closed.

Capricor Therapeutics Inc. (NASDAQ:CAPR) shares are trading higher Wednesday despite the company missing earnings per share estimates in its third-quarter results Tuesday after the market closed.

Capricor Reports Q3 Loss of 73 Cents per Share, Wider Than Expected

Capricor reported a third-quarter loss of 73 cents per share, wider than the consensus estimate of a loss of 5 cents. The company had about $199 million in cash, cash equivalents, restricted cash and marketable securities as of Sept. 30.

"This quarter, we took important steps forward on both our regulatory filing and our launch readiness," said Linda Marbán, Ph.D., Capricor’s CEO. She said the company is confident in the strength of its data as it approaches its FDA decision date, and that its San Diego facility is operational and ready to move quickly if the drug is approved.

Deramiocel’s FDA Decision Date Is Nov. 22, With Major BLA Amendment and New Two-Year Data

Capricor’s Biologics License Application for deramiocel, its treatment for Duchenne muscular dystrophy, is under FDA review with a target action date of Nov. 22, 2026. A major amendment to the application added two-year open-label extension data from the HOPE-3 trial and proposed a refined indication focused on upper limb impairment in patients older than 9. The data, presented at the World Muscle Society Congress, showed a 76% slower decline in upper limb function after patients switched from placebo to deramiocel.

Capricor’s HOPE-3 cardiac results also received the American Heart Association’s Outstanding Research Award in Pediatric Cardiology. Marbán said Capricor is encouraged by the FDA’s focus on rare disease, including its recently launched Rare Disease Framework Initiative.

Capricor Shares Trade Higher

CAPR Price Action: At the time of publication, Capricor shares are trading 15.22% higher at $10.22, according to data from Benzinga Pro.

Image via Shutterstock

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