Business
SCYNEXIS Reports Second Quarter 2021 Financial Results and Provides Corporate Update
BREXAFEMME® (ibrexafungerp tablets), the first novel antifungal class drug approved by the U.S. Food and Drug Administration (FDA) in more than 20 years,
About this update from Scynexis, Inc.
[{"type":"text","content":"BREXAFEMME® (ibrexafungerp tablets), the first novel antifungal class drug approved by the U.S. Food and Drug Administration (FDA) in more than 20 years, qualifies for 10 years of regulatory exclusivity and has 14 years of U.S. patent protectionU.S. commercial launch of BREXAFEMME began in August; the treatment is now available at pharmacies and payer discussions are rapidly progressing Clinical development of ibrexafungerp continues to progress with the completion of enrollment in the Phase 3 CANDLE study in recurrent vulvovaginal candidiasis and ongoing Phase 1 dosing of a liposomal IV formulationFurther strengthened balance sheet and projected cash runway into 2023 by accessing a $10 million tranche of Hercules/SVB debt that became available following BREXAFEMME FDA approval JERSEY CITY, N.J., Aug. 16, 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 second quarter ended on June 30, 2021 and provided an update on recent clinical and corporate developments. “We are not slowing down after our June 1, 2021 approval of BREXAFEMME, the first FDA-approved indication from our ibrexafungerp franchise,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Our commercial team has been deployed to the field to call on their healthcare provider (HCP) customers to communicate the differentiating features and benefits of BREXAFEMME. We also continue to engage in an active dialogue with payers to establish coverage. While it is still too early to assess external demand for BREXAFEMME, I am extremely proud of our team for their strong execution which we believe will translate to more tangible results to drive shareholder value in the next quarter. In addition, our clinical development team remains focused on advancing ibrexafungerp for life-threatening invasive fungal infections in the hospital setting, including work on the new intravenous (IV) formulation currently in Phase 1.” BREXAFEMME Commercial Update BREXAFEMME® (ibrexafungerp tablets) is now FDA-approved. On June 1, 2021 the New Drug Application (NDA) for BREXAFEMME was approved by the FDA, becoming the first drug from a novel antifungal class (triterpenoid) in more than 20 years. ...