$CAPR

The FDA is expected to decide on several drugs this month, including Capricor Therapeutics' Deramiocel, Regeneron and Alnylam's Cemdisiran, and Roche's Gazyva. Cemdisiran showed significant improvements in trials for generalized myasthenia gravis, while Gazyva met trial goals for primary membranous nephropathy. Roche's Giredestrant for breast cancer is also under review. Regeneron and Roche shares have risen this year, while Alnylam's have fallen.

Capricor (CAPR) reported that Deramiocel slowed arm and hand function decline by 76% in patients. The FDA is reviewing the data. CAPR has $237.9M in cash. Retail traders on Stocktwits are mixed ahead of the FDA decision. CAPR stock is down 78% YTD.

CAPR stock is on track for its worst month since July, with a November FDA decision on deramiocel approaching. Analysts have mixed ratings, with an average 12-month price target of $27, implying over 300% upside from Tuesday's close. Retail sentiment on Stocktwits has shifted from extremely bullish to bullish, with mixed opinions on the stock's potential. CAPR stock has fallen about 80% year-to-date.

Oppenheimer reiterated an Outperform rating and $54 price target for Capricor Therapeutics (CAPR) after a webinar on FDA data, citing robust HOPE-3 trial results. The stock is down 74% in six months. Other analysts also upgraded CAPR, with targets up to $25, anticipating regulatory milestones.

Capricor Therapeutics (CAPR) shares rose 5% after presenting additional heart data for Deramiocel ahead of an FDA decision on November 22. The company submitted 24-month clinical data analyses, focusing on preserving upper-limb function. The FDA initially rejected the therapy in July 2025, citing insufficient evidence, and an advisory committee recently voted 9-3 against its effectiveness for cardiomyopathy. CAPR stock is down 72% year-to-date.

Capricor presented two-year data on deramiocel, showing a 1.56-point difference in upper-limb decline for the delayed-start group. Patients treated for two years had a 3.4-point decline in PUL 2.0. Cardiac MRI data showed a 2.8% treatment effect on LVEF. The company plans to explore regulatory pathways outside the U.S. and monitor safety in combination therapies.

Capricor Therapeutics (CAPR) presented 24-month data for deramiocel, a Duchenne muscular dystrophy treatment, at the World Muscle Society Congress. Patients switching from placebo to deramiocel showed a 76% reduction in upper limb decline. The FDA is reviewing the data, with a PDUFA target date of November 22, 2026. The study included 106 patients, with 98 entering the open-label extension.

Capricor Therapeutics reported that Deramiocel slowed upper limb decline by 76% in HOPE-3 OLE data. The company included this data in a BLA amendment, with an FDA target action date of Nov. 22, 2026.

Capricor Therapeutics (CAPR) presented positive 24-month data from its HOPE-3 open-label extension study for Deramiocel, showing a 76% reduction in upper limb decline for DMD patients who switched from placebo to treatment. Both treatment groups showed slower decline than natural history predicts. The data is included in Deramiocel's BLA major amendment, with a PDUFA target action date of November 22, 2026. A webinar is scheduled for October 7, 2026, to discuss the results.

Capricor Therapeutics (CAPR) shares rose 10.5% after 24-month data for its Duchenne muscular dystrophy therapy, deramiocel, was presented at a medical conference. The FDA is reviewing the data, with a decision expected by Nov. 22. Analyst B. Riley upgraded CAPR to 'Buy' with a $21 target, citing favorable data and FDA prospects. Retail sentiment has also turned bullish.