Theratechnologies Receives March 2025 PDUFA Goal Date for Updated Tesamorelin F8 Formulation sBLA
Portfolio Pulse from
Theratechnologies Inc. announced that the FDA has set a PDUFA goal date of March 25, 2025, for its supplemental Biologics License Application for the F8 formulation of tesamorelin.
December 10, 2024 | 8:30 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Theratechnologies Inc. has received a PDUFA goal date from the FDA for its tesamorelin F8 formulation, indicating potential regulatory progress.
The assignment of a PDUFA goal date by the FDA is a significant regulatory milestone for Theratechnologies, suggesting potential progress towards approval of the tesamorelin F8 formulation. This could positively impact the stock price as it indicates advancement in the company's product pipeline.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100