Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis [Yahoo! Finance]
Vertex Pharmaceuticals Incorporated (VRTX)
Last vertex pharmaceuticals incorporated earnings: 4/29 04:01 pm
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Source: Yahoo! Finance
- EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA) BOSTON, July 02, 2024 BUSINESS WIRE Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene responsive to the vanza triple. Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months, resulting in a Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025. "The FDA acceptance of our vanza triple application and the MAA validation by the EMA represent important milestones in the decades-lo
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News
- 1 Stock That Increased 10,000% in 33 Years to Buy and Hold Forever [Yahoo! Finance]Yahoo! Finance
- Cystic Fibrosis Therapeutics Research Report 2024: A Global $15.42 Billion Market by 2032 from $7.07 Billion in 2023 - Increase in R&D Investments and Legislation that is Supportive of the Industry [Yahoo! Finance]Yahoo! Finance
- Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA [Yahoo! Finance]Yahoo! Finance
- Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic FibrosisBusiness Wire
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) was upgraded by analysts at StockNews.com from a "buy" rating to a "strong-buy" rating.MarketBeat
VRTX
Earnings
- 5/6/24 - Beat
VRTX
Sec Filings
- 6/28/24 - Form 4
- 6/27/24 - Form 8-K
- 6/26/24 - Form 144
- VRTX's page on the SEC website