Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis
Incyte Corporation (INCY)
Last incyte corporation earnings: 2/13 07:00 am
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Source: Business Wire
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 21, 2021.The FDA extended the PDUFA action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the PDUFA goal date.“We are confident in the potential of ruxolitinib cream to offer a safe and effective treatment option for atopic dermatitis and will continue to work with the FDA to bring this targeted topical therapy to patients in the U.S. as soon as possible,” said Steven Stein, M.D.
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News
- Incyte First Quarter 2024 Earnings: EPS Beats Expectations, Revenues Lag [Yahoo! Finance]Yahoo! Finance
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- Incyte to Present at Upcoming Investor ConferenceBusiness Wire
- Incyte Co. (NASDAQ: INCY) had its price target lowered by analysts at TD Cowen from $88.00 to $80.00. They now have a "buy" rating on the stock.MarketBeat
- Incyte Corporation (NASDAQ:INCY) Q1 2024 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
INCY
Earnings
- 4/30/24 - Miss
INCY
Sec Filings
- 5/9/24 - Form SC
- 5/9/24 - Form 4
- 4/30/24 - Form 10-Q
- INCY's page on the SEC website