The FDA Informed Liquidia That It Is Adding Pulmonary Hypertension Associated With Interstitial Lung Disease Indication As An Amendment To Yutrepia Application, Hence It Will Not Be Able To Meet The Prescription Drug User Fee Act Goal Date Of January 24
Portfolio Pulse from Benzinga Newsdesk
The FDA has informed Liquidia Technologies that it is amending the Yutrepia application to include an indication for Pulmonary Hypertension Associated with Interstitial Lung Disease. Consequently, the FDA will not meet the original PDUFA goal date of January 24. The review is ongoing, and no additional clinical data has been requested. A new PDUFA goal date has not been issued.
January 25, 2024 | 11:16 am
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Liquidia Technologies faces a delay in the FDA approval process for Yutrepia due to an amendment adding a new indication, with no new PDUFA goal date set.
The news indicates a delay in the approval process for Liquidia's Yutrepia, which could be seen as negative. However, the FDA not requesting additional data is positive, suggesting that the delay may not be due to concerns over the drug's efficacy or safety. The lack of a new PDUFA goal date adds uncertainty, which investors typically dislike, but the overall impact is likely neutral in the short term as the market digests the implications.
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