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Fda Decision

All articles tagged with #fda decision

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.

CRISPR Revolutionizes CAR-T Pipeline, Expands into Autoimmune Disease Amidst Exa-cel Decision
biotechnology2 years ago

CRISPR Revolutionizes CAR-T Pipeline, Expands into Autoimmune Disease Amidst Exa-cel Decision

CRISPR Therapeutics is making changes to its allogeneic CAR-T cell therapy pipeline by cutting two programs, CTX110 and CTX130, and prioritizing next-generation candidates with potential for improved clinical profiles. The company is also expanding into a new indication, autoimmune disease, while awaiting an FDA decision on its CRISPR-edited therapy exa-cel. Patients treated with CTX110 and CTX130 will be transitioned to long-term follow-up programs.