CAPRICOR THERAPEUTIC (CAPR) is drawing unusual attention today. Our newswire has captured 1 story on CAPR across 1 source in the last 36 hours, with AI sentiment reading mixed (avg 50/100).
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.
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.
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.
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.
AI-assisted analysis composed exclusively from headlines and data on the Top Tier newswire. Public view is delayed 4 hours from real time. Not financial advice.
NEW YORK and NEW ORLEANS , Sept. 11, 2026 /PRNewswire/ -- Kahn Swick & Foti , LLC ("KSF") and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., notifies investors in Capricor Therapeutics, Inc. ("Capricor" or th...
CAPRICOR THERAPEUTIC (CAPR) is drawing unusual attention today. Our newswire has captured 1 story on CAPR across 1 source in the last 36 hours, with AI sentiment reading mixed (avg 50/100). The most recent driver: "Capricor Therapeutics, Inc. Notice of September 28, 2026 Application Deadline for Class Action Lawsuit - Contact Lewis Kahn, Esq. at Kahn Swick & Foti, LLC, Before Application Deadline" (Barchart).
Top Tier Newswire does not give financial advice. Our AI sentiment across the last 36 hours of CAPR coverage reads 50/100 over 1 stories; treat it as a research signal and do your own diligence.
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More on CAPR: full news and sentiment history. Sentiment scores are AI-derived research signals, not financial advice.
Earlier CAPR move explainers: 2026-08-25 · 2026-08-24 · 2026-08-17