Capricor Therapeutics (NASDAQ:CAPR) shares rose 2.5% in pre-market trading to $10.16, following regulatory developments in August concerning the company’s biologics license application for deramiocel.
No new company-specific announcement was identified in the supplied information as a direct catalyst for Tuesday’s move.
In mid-August, the U.S. Food and Drug Administration indicated that it was willing to review a revised amendment to Capricor’s biologics license application for deramiocel, focused on preserving upper-limb function in patients with Duchenne muscular dystrophy.
The development followed an FDA advisory committee vote of 9-to-3 against the application’s original cardiomyopathy indication.
Cantor Fitzgerald raises price target to $28
On August 14, Cantor Fitzgerald upgraded Capricor Therapeutics to “Overweight” from “Neutral” and increased its price target to $28 from $3.50.
The firm linked the change to the FDA’s willingness to review the amended application and the availability of 24-month follow-up data from the HOPE-3 study.
Oppenheimer has maintained an “Outperform” rating on Capricor, while the consensus 12-month analyst price target stands at approximately $10.50, according to the supplied information. Analyst ratings and price targets represent estimates and do not indicate future share-price performance.
Capricor reports $237.9 million cash position
Capricor’s second-quarter 2026 results showed that the biotechnology company held approximately $237.9 million in cash.
Management said the available funds were sufficient to finance operations for at least 12 months.
The company is awaiting an FDA decision on deramiocel, with a Prescription Drug User Fee Act, or PDUFA, target date of November 22, 2026. The outcome of the regulatory review remains uncertain.
Shares advance as broader U.S. market declines
Capricor’s pre-market increase came as major U.S. equity indices moved lower. The Nasdaq declined 1.0%, while the S&P 500 fell 0.5% and the Dow Jones was down 0.6%.
With no new company-specific development identified on Tuesday, the information provided does not establish a definitive reason for the 2.5% pre-market increase.
The share-price move follows the FDA’s August regulatory update, Cantor Fitzgerald’s subsequent upgrade and the continued review of deramiocel ahead of the November PDUFA target date.
Capricor Therapeutics stock price
