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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News
- SCYNEXIS Presented Preclinical Data on Second Generation Fungerp SCY-247 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global, Formerly ECCMID) [Yahoo! Finance]Yahoo! Finance
- SCYNEXIS Presented Preclinical Data on Second Generation Fungerp SCY-247 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global, Formerly ECCMID)GlobeNewswire
- SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) [Yahoo! Finance]Yahoo! Finance
- SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)GlobeNewswire
- Scynexis: Update Following Restructuring Of GSK Deal [Seeking Alpha]Seeking Alpha
SCYX
Earnings
- 11/13/23 - Miss
SCYX
Sec Filings
- 4/25/24 - Form ARS
- 4/25/24 - Form DEFA14A
- 4/25/24 - Form DEF
- SCYX's page on the SEC website