Theratechnologies Has Received FDA Correspondence Regarding Its Supplemental Biologics License Application For F8 Formulation Of Tesamorelin, Notifying To Continue The Review Of The Application Beyond The PDUFA Date Of January 22
Portfolio Pulse from Benzinga Newsdesk
Theratechnologies has been informed by the FDA that the review of its supplemental Biologics License Application for the F8 formulation of Tesamorelin will extend beyond the original PDUFA date of January 22. This indicates that the FDA requires more time to evaluate the application before making a final decision.
January 23, 2024 | 12:38 pm
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NEUTRAL IMPACT
The FDA's decision to extend the review period for Theratechnologies' Tesamorelin F8 formulation may cause uncertainty among investors, potentially affecting the stock's short-term performance.
The extension of the review period by the FDA is a common occurrence and does not necessarily indicate a negative outcome. However, it does introduce uncertainty which can lead to increased volatility in the stock price. Investors may adopt a 'wait and see' approach, leading to a neutral short-term impact on THTX's stock price.
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