Tag

Capricor Therapeutics

All articles tagged with #capricor therapeutics

markets12 days ago•12 min saved

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

business12 days ago•13 min saved

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

business1 year ago•3 min saved

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