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Deramiocel

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Capricor CAPR Surges as Cantor Flips Bullish on Deramiocel FDA Path
markets12 days ago

Capricor CAPR Surges as Cantor Flips Bullish on Deramiocel FDA Path

Capricor Therapeutics' CAPR stock is spiking in premarket trading after Cantor Fitzgerald upgraded the stock to Overweight with a $28 target, citing the potential for a narrower Deramiocel indication aided by a 24-month HOPE-3 BLA extension. The FDA decision is expected by August 22. Capricor plans to amend its BLA for Deramiocel, while all other pipeline work remains on hold. The company posted a Q2 loss of $0.70 per share and held about $237.9 million in cash, with Cantor projecting up to 278% upside from current levels.

via Yahoo Finance|
#cantor-fitzgerald-upgrade#capr#capricor-therapeutics
Capricor advances amid mixed HOPE-3 data and FDA review
business12 days ago

Capricor advances amid mixed HOPE-3 data and FDA review

Capricor Therapeutics posted Q2 2026 results with no revenue, cash about $237.9 million, and a net loss of roughly $40.7 million; HOPE-3 data published in The Lancet showed a statistically significant slowing of upper limb disease progression, while an FDA advisory committee split (3 in favor, 9 against) on Deramiocel’s effectiveness for DMD cardiomyopathy left regulatory questions. The company’s BLA remains under FDA review, manufacturing readiness is advancing, and ongoing NS Pharma dispute and a Form 483 from an FDA inspection are being addressed. Capricor projects a cash runway of at least 12 months and will provide updates as regulatory clarity emerges, with regulatory engagement in Europe/Japan and a focus on expanding to younger DMD patients and Becker muscular dystrophy; other programs are on hold pending clarity.

via Capricor Therapeutics, Inc.|
#business#capricor-therapeutics#deramiocel
Capricor Advances Deramiocel BLA: FDA Seeks Full HOPE-3 CSR
biotech7 months ago

Capricor Advances Deramiocel BLA: FDA Seeks Full HOPE-3 CSR

FDA has requested the full HOPE-3 clinical study report (CSR) and supporting data to address Capricor’s Complete Response Letter for the Deramiocel BLA; Capricor will submit the CSR and updates in February 2026 to support continued FDA review and a new PDUFA date, following HOPE-3 topline data showing significant skeletal muscle and cardiac improvements in Duchenne muscular dystrophy.

via Capricor Therapeutics, Inc. (CAPR)|
#biotech#bla#deramiocel
Capricor Shares Drop After FDA Rejection of DMD Cell Therapy
business1 year ago

Capricor Shares Drop After FDA Rejection of DMD Cell Therapy

Shares of Capricor Therapeutics dropped 33% after the FDA rejected its experimental drug deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy, citing insufficient evidence of effectiveness and issues in manufacturing documentation. The company plans to continue testing with upcoming results from ongoing studies that could support future approval efforts.

via Investor's Business Daily|
#business#capricor-therapeutics#cardiomyopathy