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
MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility
For FY25, Revenue from operation grew 28.8 per cent YoY to Rs. 70.1 crore
During the quarter, US formulations revenue increased by 13.5 per cent YoY to Rs. 4,072 crore
Net profit for the?quarter came in at Rs. 2,889.1 crore, up 4.8 per cent from the year earlier, adjusted for exceptional items
The company recorded its quarterly consolidated revenue from operations at Rs. 61.22 crore in Q4 FY25
For the full year FY25, net profit soared 12x to Rs 345 crore
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%
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