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Pulmocide's lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA

Pulmocide's lead drug candidate opelconazole (PC945) granted Orphan Drug, Fast Track and Qualified Infectious Disease Product Designations by US FDA
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14 – Alpha Demethylase Inhibitors Pipeline Research Report 2021 – ResearchAndMarkets.com

14 – Alpha Demethylase Inhibitors Pipeline Research Report 2021 – ResearchAndMarkets.com
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FDA Approves Ibrexafungerp for Vaginal Yeast Infection

FDA Approves Ibrexafungerp for Vaginal Yeast Infection
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Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treat

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01-Jun-2021
Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
- NDA supported by positive data from VIOLET and ultraVIOLET Phase 3 clinical trials evaluating oteseconazole in more than 870 women in 11 countries -
- Oteseconazole’s Qualified Infectious Disease Product and Fast-Track designations allow for six-month priority review by FDA following its acceptance of the NDA -
DURHAM, N.C. (BUSINESS WIRE) Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced it has submitted its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC). Also known as chronic yeast infection, RVVC is ....

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Mycovia Pharmaceuticals Announces Positive Topline Results from its Third Phase 3 Clinical Trial (ultraVIOLET) of Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis

Published: Jan 06, 2021

- Efficacy of Oteseconazole Compared to Fluconazole in Treating Acute VVC Infection in Women with RVVC -
- NDA Submission Planned in First Half of 2021 -

DURHAM, N.C. (BUSINESS WIRE) Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced positive topline results from its Phase 3 clinical trial for oteseconazole (ultraVIOLET), its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC). RVVC, commonly known as chronic yeast infection, is a debilitating infectious condition defined as three or more episodes per year. Oteseconazole is designed to be highly selective for its pathogenic target, with fewer side effects and improved efficacy over current treatment options, including the current standard of care for vulvovaginal candidiasis (VVC), flucon ....

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