Vertex Pharmaceuticals Announces FDA Acceptance Of NDA For Vanza Triple Therapy With Priority Review, PDUFA Target Date Set For January 2, 2025; EU Marketing Authorization Application Also Validated By EMA For Cystic Fibrosis Treatment
Portfolio Pulse from Benzinga Newsdesk
Vertex Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for Vanza Triple Therapy with a priority review, setting a PDUFA target date for January 2, 2025. Additionally, the EU Marketing Authorization Application has been validated by the EMA for the treatment of cystic fibrosis.
July 02, 2024 | 12:34 pm
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Vertex Pharmaceuticals' NDA for Vanza Triple Therapy has been accepted by the FDA with a priority review, and the EU Marketing Authorization Application has been validated by the EMA for cystic fibrosis treatment.
The acceptance of the NDA with a priority review by the FDA and the validation of the EU Marketing Authorization Application by the EMA are significant regulatory milestones. These developments increase the likelihood of Vanza Triple Therapy reaching the market, which could positively impact Vertex Pharmaceuticals' stock price in the short term.
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