Capricor Therapeutics Inc. (CAPR) Plunges 29.13% Amid FDA Review

Capricor Therapeutics Inc. (CAPR) shares plummeted 29.13% today, marking the third consecutive day of decline, with a cumulative drop of 42.70% over the past three days. The stock price hit its lowest level since September 2024, experiencing an intraday decline of 32.33%.

The strategy of buying CAPR shares after they reached a recent low and holding for 1 week yielded moderate returns over the past 5 years, with a 33.33% increase from May 5, 2020, to May 5, 2025. This approach capitalized on the stock's rebound following periods of low valuation, though the overall performance was impacted by CAPR's volatility and the market's dynamics.

Capricor Therapeutics' recent stock decline appears to be linked to the market's reaction following a mid-cycle review meeting with the FDA. The review found no significant deficiencies in the company's Biologics License Application for deramiocel, a treatment for Duchenne Muscular Dystrophy (DMD) cardiomyopathy. Despite this positive outcome, which increases the likelihood of approval by the August 31, 2025, PDUFA date, the stock has experienced a significant drop. The anticipation of an FDA advisory committee meeting, a standard procedure for novel therapies, may also be contributing to the stock's volatility. Additionally, broader market movements, including declines in other biotech stocks, may have influenced CAPR's performance.

Investors are closely monitoring the upcoming FDA advisory committee meeting, which is expected to provide further clarity on the regulatory path for deramiocel. The outcome of this meeting could significantly impact Capricor's stock price, as it will offer insights into the potential approval timeline and market expectations. The company's focus on developing innovative treatments for rare diseases positions it as a key player in the biotech sector, but the regulatory process remains a critical factor in its stock performance.

Capricor's recent developments, including the positive mid-cycle review, highlight the company's progress in advancing its pipeline. However, the market's reaction suggests that investors are cautious about the regulatory risks associated with novel therapies. The upcoming FDA advisory committee meeting will be a pivotal moment for Capricor, as it could either alleviate or exacerbate investor concerns. The company's ability to navigate the regulatory landscape and deliver on its promises will be crucial in determining its future stock performance.