Business
SCYNEXIS Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
FDA accepted SCYNEXIS’ New Drug Application (NDA) for oral ibrexafungerp for the treatment of vaginal yeast infections, conditionally approved the brand name
About this update from Scynexis, Inc.
[{"type":"text","content":"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, 2021SCYNEXIS 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 deferredSCYNEXIS 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 salesEnrollment 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 2022SCYNEXIS 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 aurisBased 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 JERSEY CITY, N.J., March 29, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the fourth quarter ended on December 31, 2020 and provided an update on recent clinical and corporate developments. “This has been an extremely active period for our team as we build out the commercial infrastructure in preparation for the anticipated approval of Brexafemme for vaginal yeast infections on June 1, 2021, while advancing the hospital clinical programs in both the oral and IV formulations,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Between our successful $85 million public offering in December and our recent $10 million upfront payment in connection with our partnership with Hansoh Pharma...