SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK
Rhea-AI Summary
SCYNEXIS (NASDAQ: SCYX) completed transfer of the BREXAFEMME (ibrexafungerp) NDA to GSK on November 19, 2025. GSK can now initiate regulatory interactions with the FDA to discuss a U.S. relaunch for vulvovaginal candidiasis (VVC) and refractory VVC (rVVC). Following a relaunch, SCYNEXIS stands to receive up to $145.5 million in annual net sales milestones plus royalties, which are payable net of amounts due to Merck and expected in the low- to mid-single digit percentage range. The company describes these payments as a potential source of future non-dilutive capital.
Positive
- Potential $145.5 million annual net-sales milestone opportunity
- Royalties payable in the low-to-mid single-digit percentage range
Negative
- Relaunch depends on GSK initiating FDA regulatory interactions
- Royalties reduced net of payments to Merck, lowering SCYNEXIS proceeds
News Market Reaction – SCYX
In the Nov 19 session, SCYX gained 1.76%, reflecting a mild positive market reaction. Argus tracked a peak move of +18.2% during that session. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility. Trading volume was exceptionally heavy at 5.2x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- GSK remains committed to the relaunch of BREXAFEMME, and following its relaunch, SCYNEXIS stands to receive up to
$145.5 million in annual net sales milestones as well as royalties, net of payments to Merck, in the low to mid single digit range
JERSEY CITY, N.J., Nov. 19, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application (NDA) to 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 (VVC) 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.”
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps.” Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) has approved BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: receipt of milestones and royalties from GSK. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 12, 2025, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com
