Capricor Therapeutics beats Q4 estimates, shares rise on FDA acceptance

Published 19/03/2025, 21:18
Capricor Therapeutics beats Q4 estimates, shares rise on FDA acceptance

SAN DIEGO - Capricor Therapeutics (NASDAQ:CAPR) reported better-than-expected fourth quarter results and announced a key regulatory milestone for its lead drug candidate, sending shares up 2.3% in after-hours trading.

The biotechnology company posted adjusted earnings per share of -$0.16 for Q4, beating analyst estimates by $0.01. Revenue came in at $11.13 million, significantly above the consensus forecast of $3.52 million and down 8% YoY.

Capricor’s fourth quarter was highlighted by the U.S. Food and Drug Administration’s acceptance of its Biologics License Application for deramiocel to treat Duchenne muscular dystrophy cardiomyopathy. The FDA granted priority review with a target action date of August 31, 2025.

"2024 was a transformational year for Capricor as we move closer to our goal of bringing the first cellular therapy to market for the treatment of Duchenne-cardiomyopathy," said CEO Linda Marbán. She noted the company is preparing for potential commercial launch with partner Nippon Shinyaku.

Capricor ended 2024 with a cash balance of $151.5 million, which it expects will fund operations into 2027. The company received a $10 million milestone payment from Nippon Shinyaku in January 2025.

For the full year 2024, Capricor reported a net loss of $40.5 million, or -$1.15 per share, compared to a loss of $22.3 million, or -$0.83 per share, in 2023. Annual revenue declined to $22.3 million from $25.2 million the prior year.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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