Capricor says Deramiocel BLA under active FDA review after AdCom vote
Capricor (CAPR) says Deramiocel’s BLA remains under active FDA review and it still sees a path to approval after a 3-9 AdCom vote, citing HOPE-3’s primary endpoint (p=0.029) and $~238M cash at Q2 end.
CAPR says Deramiocel's BLA remains under active FDA review and it continues to see a path to approval despite the 3-9 AdCom vote.
Capricor also ended Q2 with ~$238M in cash and says it has enough liquidity to fund operations for at least the next 12 months, reducing near-term financing concerns.
The company highlighted that HOPE-3 met its primary upper-limb endpoint at p=0.029, while the AdCom was not asked to vote on that endpoint or overall benefit-risk.
A regulatory update is expected on today's 4:30 PM ET call.