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SCYX News and Press, SCYNEXIS Inc. From 08/04/22

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Company Name: SCYNEXIS Inc.
Stock Symbol: SCYX
Market: NASDAQ
Website: scynexis.com
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SCYX - SCYNEXIS Presents Positive Data from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections During the 2022 IDSOG Annual Meeting

The CANDLE study met its primary endpoint, with 65.4% of patients with recurrent vulvovaginal candidiasis (RVCC) who received monthly single-day ibrexafungerp treatment achieving clinical success with no recurrence at all, either culture-proven, presumed or suspected. Ibrexafunger...
SCYX - FDA accepts Scynexis' application to expand label for vaginal yeast infections treatment

Scynexis ( NASDAQ: SCYX ) on Monday said the U.S. Food and Drug Administration (FDA) had accepted the biotech's supplemental new drug application (sNDA) to expand the label of its Brexafemme tablets to include the prevention of recurrent vulvovaginal candidiasis. ...

SCYX - SCYNEXIS Announces U.S. Food and Drug Administration Acceptance and Priority Review of the Supplemental New Drug Application for BREXAFEMME® (ibrexafungerp tablets) for Prevention of Recurrent Vaginal Yeast Infections

Submission has been granted priority review and given a target regulatory decision date of November 30, 2022. If approved for this second indication, BREXAFEMME would be the first and only therapy approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and th...

SCYX - SCYNEXIS gains after favorable data for antifungal agent in new indication

SCYNEXIS ( NASDAQ: SCYX ) added ~8% in the morning hours Tuesday after the commercial-stage pharma company announced promising Phase 3 data for its oral antifungal medication ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC). According to the dat...
SCYX - SCYNEXIS Presents Positive Data from Phase 3 CANDLE Nested Sub-Study Investigating Ibrexafungerp in Women with Recurrent Yeast Infections Who Failed Fluconazole During the ISSVD XXVI World Congress and International Vulvovaginal Disease Update

Data show that 71% of 24 patients with recurrent vulvovaginal candidiasis (RVVC) who failed to respond to a three-day regimen of fluconazole achieved a substantial reduction or complete elimination of signs and symptoms after receiving a one-day treatment with ibrexafungerp. Data ...

SCYX - SCYNEXIS to Present Data from the CANDLE Nested Sub-Study of Ibrexafungerp During the International Society for the Study of Vulvovaginal Disease (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update

JERSEY CITY, N.J., July 14, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that data from the CANDLE 304s nested sub-study of ibrexafung...

SCYX - SCYNEXIS Announces Initiation of New Phase 3b Study (VANQUISH) to Evaluate Oral Ibrexafungerp as a Treatment for Complicated Vulvovaginal Candidiasis (VVC) in Patients Who Failed to Respond to Treatment with Fluconazole

JERSEY CITY, N.J., June 23, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced the initiation and first patient enrolled in a new Phase...
SCYX - SCYNEXIS Announces Submission of Supplemental New Drug Application of BREXAFEMME® (ibrexafungerp tablets) to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections

Regulatory submission for the label extension is supported by positive data from the pivotal Phase 3 CANDLE study in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. If approved, BREXAFE...

SCYX - SCYNEXIS to Present at Upcoming H.C. Wainwright Global Investment Conference

JERSEY CITY, N.J., May 20, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that Marco Taglietti, President and Chief Executive Offic...

SCYX - SCYNEXIS, Inc. (SCYX) CEO Marco Taglietti on Q1 2022 Results - Earnings Call Transcript

SCYNEXIS, Inc. (SCYX) Q1 2022 Earnings Conference Call May 12, 2022, 8:30 AM ET Company Participants Marco Taglietti – President and Chief Executive Officer Christine Coyne – Chief Commercial Officer Dr. David Angulo – Chief Medical Officer Lawrence Hoffman – Inter...
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