SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study
Rhea-AI Summary
SCYNEXIS (NASDAQ:SCYX) resolved its disagreement with GSK over restarting the Phase 3 MARIO study on invasive candidiasis and will wind down and terminate MARIO.
As part of the resolution, SCYNEXIS will receive a $22.0 million payment plus an additional $2.3 million for wind-down activities. The company said the payment, combined with cash on hand and the removal of future MARIO expenses, extends its cash runway to more than two years. GSK reiterated its commitment to commercialize BREXAFEMME and to collaborate on transferring the BREXAFEMME NDA to GSK by end of 2025, with GSK planning FDA interactions in 2026 regarding relaunch in the U.S.
Positive
- $22.0M payment from GSK
- $2.3M additional wind-down payment
- Cash runway extended to more than two years
- GSK committed to commercialize BREXAFEMME
- BREXAFEMME NDA transfer targeted by end of 2025
Negative
- Phase 3 MARIO study will be promptly wound down and terminated
- No additional MARIO-related milestone payments from GSK
News Market Reaction – SCYX
On the day this news was published, SCYX declined 0.30%, reflecting a mild negative market reaction. Argus tracked a peak move of +5.3% during that session. Argus tracked a trough of -10.5% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $107K from the company's valuation, bringing the market cap to $36M at that time.
Data tracked by StockTitan Argus on the day of publication.
- SCYNEXIS to receive a
$22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasis - Scynexis will promptly wind-down and terminate the MARIO study
- The payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two years
- GSK remains committed to the commercialization of BREXAFEMME (ibrexafungerp tablets)
JERSEY CITY, N.J., Oct. 15, 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 will receive a
GSK has also reiterated its commitment to continued collaboration with SCYNEXIS regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME (ibrexafungerp tablets) for the vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) indications. SCYNEXIS continues to progress the transfer of the BREXAFEMME NDA to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the U.S. Food and Drug Administration in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market.
“While disappointed that the MARIO study will not continue, we’re pleased to have resolved this disagreement with GSK and that it remains committed to relaunching BREXAFEMME. SCYNEXIS remains committed to developing novel antifungal solutions, including SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation,” said David Angulo, M.D., President and Chief Executive Officer. “We want to thank all of the patients who participated in the MARIO study and the investigators for their continued support toward finding new antifungal agents in areas of significant unmet need.”
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) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, 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: any advantages of SCY-247 over existing antifungals, continued development of SCY-247, and the Company’s cash runway. 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
FAQ
What did SCYNEXIS announce about the Phase 3 MARIO study on Oct 15, 2025 (SCYX)?
How much will SCYNEXIS receive from GSK as part of the MARIO resolution (SCYX)?
How does the GSK payment affect SCYNEXIS cash runway (SCYX)?
Will SCYNEXIS receive future MARIO milestone payments from GSK (SCYX)?
What is the timing for the BREXAFEMME NDA transfer and U.S. regulatory interactions (SCYX)?
Will GSK continue working with SCYNEXIS on BREXAFEMME commercialization (SCYX)?
