Regenxbio Inc (RGNX) showcases robust financial positioning and strategic progress in gene therapy, despite challenges in ...

Capricor Therapeutics (CAPR) announced the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking ...

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...

Robust, Consistent Phase 3 Data and Real-World Evidence Outcomes Support ANX005 as Potential First Targeted Therapy for GBS; Pre-BLA Meeting ...

On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s (NASDAQ:CAPR) Biologics License Application for ...

As the company prepares for its regulatory meetings ... Licensing Application (BLA) submission, expected in the second quarter of 2025, and anticipates FDA approval within six months of filing.

Additionally, the FDA granted the BLA Priority Review with a Prescription ... they have not yet decided whether an Advisory Committee meeting is needed regarding this application.

In addition to the Priority Review, deramiocel has received Orphan Drug Designation from the FDA and EMA, as well as RMAT and ATMP Designations in the U.S. and Europe, respectively. Furthermore, ...

for clesrovimab and set a Prescription Drug User Fee Act (PDUFA) date of 10 June 2025. Data supporting the BLA comes from two trials for which results were presented during the IDWeek meeting in ...

We look forward to the pre-BLA meeting with FDA targeted for the first half of 2025 ahead of our BLA submission.” Mr. Love continued, “We are also enthusiastic about recent positive regulatory ...

Financially, Annexon has a strong cash position, providing a runway of 5-8 quarters, but the stock trades almost at cash due ...