Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio
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
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
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
The initiative was announced at World Hypertension Congress, Chennai
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs
Akums invested Rs. 272 crore in capital expenditure during FY25
The company recorded its quarterly consolidated revenue from operations at Rs. 61.22 crore in Q4 FY25
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