SCYX SCYNEXIS INC

SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study

SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study

  • 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 $22 million payment from GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) as part of a resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study on invasive candidiasis. SCYNEXIS will not receive additional milestone payments from GSK associated with the MARIO study. SCYNEXIS will promptly commence appropriate wind-down activities associated with its termination and will receive an additional $2.3M payment in connection with these activities.

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

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



EN
15/10/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on SCYNEXIS INC

 PRESS RELEASE

SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK

SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK 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: ), 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 BREXAFEMM...

 PRESS RELEASE

Scynexis Announces Federal Funding of Collaboration Between Hackensack...

Scynexis Announces Federal Funding of Collaboration Between Hackensack Meridian CDI and Johns Hopkins Researchers to Develop New Therapeutics, Including Novel Fungerps, for Resistant Fungal Infections Five-year grant of $7 million annually to the academic researchers is aimed at accelerating the development of new therapeutics to combat resistant fungal infections, including the Company’s next generation of triterpenoid antifungals (fungerps).Next-generation fungerps, in preclinical stages of development, are targeted to have enhanced pharmacological properties to treat fungal infections wh...

 PRESS RELEASE

SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Cor...

SCYNEXIS Reports Third Quarter 2025 Financial Results and Provides Corporate Update SCYNEXIS to receive one-time payments totalling $24.8 million from GSK as part of the resolution of the disagreement related to the restart of the Phase 3 MARIO study in invasive candidiasis. Scynexis agreed to GSK’s request to terminate the study.Following the positive SAD/MAD data results announced in September for SCY-247, its second-generation fungerp, the Company expects to initiate a Phase 1 study with the IV formulation and a Phase 2 study for the treatment of invasive candidiasis. The Company aims to...

 PRESS RELEASE

SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of ...

SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasisScynexis will promptly wind-down and terminate the MARIO studyThe payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two yearsGSK remains committed to the commercialization of BREXAFEMME (ibrexafungerp tablets) JERSEY CITY, N.J., Oct. 15, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, In...

 PRESS RELEASE

SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending D...

SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247) No safety concerns or dose limiting toxicities observed SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247 JERSEY CITY, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and dru...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch