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The NDA submission was supported by positive data from the phase 3 PHALCON-NERD-301 study and has been assigned a standard 10-month review with a PDUFA target action date of July 19, 2024.
The approval was based on data from the APPLY-PNH trial and APPOINT-PNH study, which showed iptacopan was superior for hemoglobin improvement in the absence of red blood cell transfusions and in transfusion avoidance rate compared to patients who stayed on anti-C5 treatments.
It's not ready for the market yet, but Dr. Thomas Wagner remains optimistic.
This data from the NOTUS trial is set to be submitted to the FDA alongside the phase 3 BOREAS trial data later in the year.
BMRCL is set to commence landwork for Metro Phase 3 in Bengaluru. The project involves the acquisition of land for building a depot and viaducts. Get all the details about the project and its estimated cost.