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Capricor Therapeutics ( (CAPR) ) has shared an announcement.
On July 11, 2025, Capricor Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Deramiocel, a cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy. The FDA cited the need for additional clinical data and outstanding items in the Chemistry, Manufacturing, and Controls section. Capricor plans to resubmit its BLA with data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 and intends to engage with the FDA to discuss the path forward. The company remains committed to advancing Deramiocel through the approval process despite the unexpected FDA decision.
The most recent analyst rating on (CAPR) stock is a Buy with a $77.00 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.
Spark’s Take on CAPR Stock
According to Spark, TipRanks’ AI Analyst, CAPR is a Neutral.
Capricor Therapeutics’ overall score reflects its significant potential due to advancements in drug development and strategic partnerships, particularly for deramiocel. However, persistent financial challenges, particularly profitability and cash flow issues, weigh heavily on the stock’s outlook. Technical indicators show mixed signals, and valuation remains speculative with a negative P/E ratio.
To see Spark’s full report on CAPR stock, click here.
More about Capricor Therapeutics
Capricor Therapeutics is a biotechnology company focused on developing transformative cell and exosome-based therapeutics for rare diseases. Its lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy aimed at treating Duchenne Muscular Dystrophy (DMD). Capricor is also working on its proprietary StealthX™ platform for targeted delivery of therapeutics.
Average Trading Volume: 2,649,563
Technical Sentiment Signal: Buy
Current Market Cap: $522M
For detailed information about CAPR stock, go to TipRanks’ Stock Analysis page.