SCYNEXIS Announces Special Protocol Assessment (SPA) Agreement with FDA for Phase 3 Study Evaluating Oral Ibrexafungerp for the Prevention of Recurrent Vulvovaginal Candidiasis (VVC) (CAND...
SCYNEXIS, Inc. (SCYX)
Last scynexis, inc. earnings: 11/12 08:30 am
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Source: PR Newswire
JERSEY CITY, N.J., July 24, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on the design, trial population, endpoints and statistical analysis of the CANDLE study, its pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies. Additionally, a sub-study assessing the efficacy of ibrexafungerp in treating the ongoing acute VVC infections in recurrent VVC patients who failed to sufficiently respond to
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SCYX
News
- SCYNEXIS, Inc. (NASDAQ: SCYX) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- SCYNEXIS Third Quarter 2024 Earnings: EPS Beats Expectations, Revenues Lag [Yahoo! Finance]Yahoo! Finance
- SCYNEXIS Reports Third Quarter 2024 Financial Results and Provides Corporate Update [Yahoo! Finance]Yahoo! Finance
- SCYNEXIS Reports Third Quarter 2024 Financial Results and Provides Corporate UpdateGlobeNewswire
- SCYNEXIS to Participate in the 2024 Maxim Healthcare Virtual SummitGlobeNewswire
SCYX
Earnings
- 11/6/24 - Beat
SCYX
Sec Filings
- 11/14/24 - Form SC
- 11/6/24 - Form 8-K
- 11/6/24 - Form 424B5
- SCYX's page on the SEC website