SCYNEXIS Inc.
03/29/2021 | Press release | Distributed by Public on 03/29/2021 06:20
SCYNEXIS Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
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FDA accepted SCYNEXIS' New Drug Application (NDA) for oral ibrexafungerp for the treatment of vaginal yeast infections, conditionally approved the brand name BrexafemmeTM, and granted priority review with a PDUFA target action date of June 1, 2021
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SCYNEXIS partnered with Amplity Health, a leading global contract commercialization organization, in connection with anticipated U.S. launch of Brexafemme in the second half of 2021, with a portion of Amplity's direct fees deferred
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SCYNEXIS out-licensed the rights to ibrexafungerp for the Greater China region to Hansoh Pharma, resulting in a $10 million upfront payment and the potential for up to $112 million in additional milestones plus royalties on sales
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Enrollment is complete in the Phase 3 CANDLE study of oral ibrexafungerp for the prevention of recurrent vaginal yeast infections; last-patient / last-visit expected by the end of the year with top-line results and a supplemental NDA submission anticipated in the first half of 2022, resulting in a potential approval in late 2022
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SCYNEXIS announced positive results from interim analyses of ongoing Phase 3 studies (FURI and CARES), showing oral ibrexafungerp's ability to treat severe fungal infections in the hospital setting, including those caused by Candida auris
- Based on cash balance at December 31st and subsequent Q1 2021 upfront payment from Hansoh, SCYNEXIS is in a strong financial position to execute on its plans with a projected cash runway into 2023