News | July 15, 2025
Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Capricor’s BLA for Deramiocel received Priority Review in March 2025
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
For the 2024 outlook, sales growth is now expected to be 22-28% at CER
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
The CRL did not identify any outstanding scientific issues with the product.
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
The company will review FDA's response and decide on appropriate next steps soon.
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