SCYNEXIS and GSK Resolve Their Disagreement Related to the Restart of the Phase 3 MARIO Study
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.
SCYNEXIS (NASDAQ:SCYX) ha risolto il suo disaccordo con GSK riguardo al riavvio dello studio di fase 3 MARIO sull'infezione invasiva da candida e porrà fine a MARIO.
Come parte della risoluzione, SCYNEXIS riceverà un pagamento di $22.0 milioni oltre a ulteriori $2.3 milioni per le attività di smobilizzo. L'azienda ha detto che il pagamento, insieme alla liquidità disponibile e all'eliminazione dei futuri costi MARIO, estende l'orizzonte di cassa a più di due anni. GSK ha ribadito il proprio impegno a commercializzare BREXAFEMME e a collaborare nel trasferimento dell'NDA di BREXAFEMME a GSK entro la fine del 2025, con GSK che prevede interazioni FDA nel 2026 riguardo al rilancio negli Stati Uniti.
SCYNEXIS (NASDAQ:SCYX) resolvió su desacuerdo con GSK sobre reiniciar el estudio de Fase 3 MARIO en la candidiasis invasiva y terminará MARIO.
Como parte de la resolución, SCYNEXIS recibirá un pago de $22.0 millones además de $2.3 millones para las actividades de liquidación. La compañía dijo que el pago, junto con la caja disponible y la eliminación de futuros gastos de MARIO, amplía su horizonte de caja a más de dos años. GSK reiteró su compromiso de comercializar BREXAFEMME y de colaborar en la transferencia del NDA de BREXAFEMME a GSK para fin de 2025, con GSK planeando interacciones con la FDA en 2026 respecto al relanzamiento en EE. UU.
SCYNEXIS (나스닥:SCYX)은 침습성 칸디다증에서의 3상 MARIO 연구 재개에 대한 GSK와의 이견을 해결하고 MARIO를 종료하고 종결할 것입니다.
해결의 일환으로 SCYNEXIS는 $22.0 million의 지불을 받으며, 해산 활동을 위한 추가 $2.3 million이 지급됩니다. 회사는 이 지불이 현금 보유액과 MARIO의 향후 비용 제거와 함께 현금 흐름의 예상 기간을 2년 이상으로 연장한다고 밝혔습니다. GSK는 BREXAFEMME의 상용화에 대한 의지와 BREXAFEMME NDA를 GSK로 양도하는 데 협력하겠다는 약속을 재확인했으며, 2025년 말까지 NDA를 GSK로 이전하는 데 합의했고, GSK는 미국 재출시를 위한 2026년에 FDA와의 상호작용을 계획하고 있습니다.
SCYNEXIS (NASDAQ:SCYX) a résolu son désaccord avec GSK concernant la reprise de l'étude de phase 3 MARIO sur la candidose invasives et mettra fin à MARIO.
Dans le cadre de la résolution, SCYNEXIS recevra un paiement de $22.0 millions ainsi qu'un montant supplémentaire de $2.3 millions pour les activités de dissolution. L'entreprise a déclaré que le paiement, combiné à la trésorerie disponible et à la suppression des coûts futurs de MARIO, prolonge son horizon de liquidité à plus de deux ans. GSK a réitéré son engagement à commercialiser BREXAFEMME et à collaborer au transfert du NDA de BREXAFEMME vers GSK d'ici fin 2025, avec GSK prévoyant des interactions avec la FDA en 2026 concernant le relancement aux États-Unis.
SCYNEXIS (NASDAQ:SCYX) hat seinen Streit mit GSK über die Wiederaufnahme der Phase-3-Studie MARIO bei invasiver Candidiasis beigelegt und MARIO wird beendet und eingestellt.
Im Rahmen der Einigung wird SCYNEXIS eine Zahlung von $22.0 million erhalten sowie weitere $2.3 million für Abwicklungsaktivitäten. Das Unternehmen sagte, dass die Zahlung zusammen mit verfügbarem Bargeld und dem Wegfall zukünftiger MARIO-Kosten die Barreserve auf über zwei Jahre verlängert. GSK bekräftigte sein Engagement, BREXAFEMME zu kommerzialisieren, und eine Zusammenarbeit beim Transfer des BREXAFEMME-NDA zu GSK bis Ende 2025 zu ermöglichen, wobei GSK plant, in 2026 FDA-Interaktionen im Hinblick auf das US-Relauch durchzuführen.
SCYNEXIS (المُدرج فيNasdaq: SCYX) حلت خلافها مع GSK بشأن إعادة بدء دراسة المرحلة 3 MARIO حول عدوى المبيضات الغازية، وستُنهي MARIO.
كجزء من الحل، ستتلقى SCYNEXIS دفعة قدرها $22.0 مليوناً بالإضافة إلى $2.3 مليون لأعمال الإنهاء. قالت الشركة إن الدفعة، إلى جانب النقد المتاح وإزالة نفقات MARIO المستقبلية، تمد فترة التدفق النقدي إلى أكثر من عامين. كررت GSK التزامها بتسويق BREXAFEMME والتعاون في نقل NDA BREXAFEMME إلى GSK بحلول نهاية 2025، مع تخطيط GSK لإجراء تواصُلات مع FDA في 2026 فيما يخص إعادة الإطلاق في الولايات المتحدة.
SCYNEXIS (纳斯达克股票代码：SCYX) 已经解决了与GSK之间关于在侵袭性念珠菌病中重新启动第三阶段研究MARIO的分歧，并将结束并终止MARIO。
作为解决的一部分，SCYNEXIS将获得一笔金额为$22.0 million的支付，以及用于清算活动的额外$2.3 million。公司表示，该笔支付与手头现金以及取消未来的MARIO费用相结合，将其现金走廊延长至超过两年。GSK重申其致力于商业化BREXAFEMME并与之合作，将BREXAFEMME的NDA转移给GSK，时间在2025年末，GSK计划在2026与FDA进行美国重新上市相关的互动。
- $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
- Phase 3 MARIO study will be promptly wound down and terminated
- No additional MARIO-related milestone payments from GSK
Insights
Receipt of
SCYNEXIS will receive
Key dependencies and risks remain limited to the facts disclosed: the company will not receive further MARIO milestones, and future funding needs will depend on burn outside MARIO. Monitor the pace of NDA transfer to GSK by
Stopping MARIO ends a Phase 3 program but preserves capital while preserving a commercialization pathway for BREXAFEMME.
SCYNEXIS will promptly wind down and terminate the Phase 3 MARIO study and will not receive further MARIO milestone payments. GSK reiterated commitment to commercialize BREXAFEMME and to continue collaboration under the license agreement, and SCYNEXIS continues the transfer of the BREXAFEMME NDA to GSK by
Operationally, the decisive items to watch are the completed NDA transfer by
- 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)?
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