Why Is CAPRICOR THERAPEUTIC (CAPR) Stock Moving Today?

Capricor Therapeutics stock is moving higher today after the FDA extended the review period for its deramiocel application. The stock opened with a 6.0% gap up from the prior close and has traded between $7.06 and $7.43 in the session so far. The update from the FDA, which pushed the PDUFA target action date from August 22 to November 22, has sparked renewed investor interest in the company.

What Happened

Oppenheimer upgraded Capricor stock to Outperform from Perform, citing the regulatory update. The FDA’s decision to extend the review period suggests that the agency is seeking additional information or clarification regarding the drug’s application. This comes after an advisory panel had previously recommended against approval, raising concerns about the therapy’s efficacy and data integrity. Capricor has submitted additional information to address these concerns, and the extension allows the company more time to engage with the agency.

A securities class action lawsuit has also been filed against Capricor, alleging misstatements about the clinical data supporting deramiocel. The lawsuit followed a 64.5% stock drop earlier in the year, which was attributed to concerns over the drug’s regulatory prospects. The recent upgrade from Oppenheimer and the FDA extension appear to have temporarily lifted investor sentiment.

What The Data Shows

Capricor shares opened at $7.21 and have traded in a narrow range, with volume so far at 0.4 million shares, 0.1 times the 3-month average. The stock has surged 54.5% over the past eight sessions, rising from $4.40 to $6.80. Over the last 52 weeks, the stock has traded as low as $2.96 and as high as $40.37. Recent insider transactions include four sales totaling $1.5 million in the last 90 days, with no insider purchases reported. The stock printed 14 fresh 52-week lows on August 25.

What To Watch

Capricor has no upcoming earnings date listed. Investors should monitor the FDA’s final decision on the deramiocel application, expected in November, as well as any further developments in the ongoing securities class action. Coverage breadth remains limited, with 21 stories from 12 sources in the last 36 hours.