SCYX News & Events

Scynexis announced that the U.S. Food and Drug Administration, FDA, has granted the Company Qualified Infectious Disease Product, QIDP, and Fast Track Designations, FTD, for its second-generation triterpenoid antifungal therapy, SCY-247. In 2026, the Company expects to initiate a Phase 1 study of SCY-247 with the IV formulation as well as a Phase 2 study with the oral formulation in invasive candidiasis. Scynexis also aims to release proof-of -concept data for the oral formulation of SCY-247 in IC in 2026. Considering the differentiated attributes of SCY-247 and its potential role to counter health security threats posed by antifungal resistance development, the company will also continue exploring potential non-dilutive funding opportunities to further support this program.

SCYNEXIS announced that it has received an additional 180-calendar-day extension from the Nasdaq Stock Market to regain compliance with the minimum bid price requirement, as outlined in Nasdaq Listing Rule 5550(a)(2). The Company now has until June 15, 2026, to meet the requirement for its shares of common stock to maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. Nasdaq granted the extension after determining that SCYNEXIS continues to meet all other continued listing criteria for the Nasdaq Capital Market.

SCYNEXIS (SCYX) announced that it has completed the transfer of the BREXAFEMME New Drug Application, NDA, to GSK (GSK). "We are pleased to announce this important milestone for SCYNEXIS. With the transfer of the BREXAFEMME NDA now complete, GSK will be able to initiate regulatory interactions with the U.S. Food and Drug Administration (FDA) to discuss the relaunch of BREXAFEMME for vulvovaginal candidiasis and refractory vulvovaginal candidiasis (rVVC) in the U.S. market," said David Angulo, M.D., President and Chief Executive Officer. "Furthermore, SCYNEXIS stands to receive net sales milestones and royalties following the relaunch providing a significant future source of non-dilutive capital."