SCYNEXIS Completes Transfer of BREXAFEMME® New Drug Application to GSK
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.
SCYNEXIS (NASDAQ: SCYX) ha completato il trasferimento della BREXAFEMME (ibrexafungerp) NDA a GSK il 19 novembre 2025. GSK può ora avviare interazioni regolatorie con la FDA per discutere un rilancio negli Stati Uniti per la candidosi vulvovaginale (VVC) e VVC refrattaria (rVVC). A seguito di un rilancio, SCYNEXIS potrebbe ricevere fino a 145,5 milioni di dollari in traguardi di vendite nette annue più royalties, pagabili al netto degli importi dovuti a Merck e previsti nell'intervallo da basso a medio a una sola cifra percentuale. L'azienda descrive questi pagamenti come una potenziale fonte di capitale non diluitivo in futuro.
SCYNEXIS (NASDAQ: SCYX) completó la transferencia de la NDA de BREXAFEMME (ibrexafungerp) a GSK el 19 de noviembre de 2025. GSK puede ahora iniciar interacciones regulatorias con la FDA para discutir un relanzamiento en EE. UU. para la candidiasis vulvovaginal (VVC) y VVC refractaria (rVVC). Tras el relanzamiento, SCYNEXIS podría recibir hasta 145,5 millones de dólares en hitos de ventas netas anuales más regalías, pagaderas netas de los importes debidos a Merck y se esperan en el rango de un dígito bajo a medio por ciento. La compañía describe estos pagos como una posible fuente de capital no dilutivo en el futuro.
SCYNEXIS (NASDAQ: SCYX)은 BREXAFEMME (ibrexafungerp) NDA를 GSK로 이전하는 것을 2025년 11월 19일에 완료했습니다. 이제 GSK는 FDA와 규제 상의 대화를 시작해 미국에서의 질염(VVC) 및 재발성 질염(rVVC)의 재출시를 논의할 수 있습니다. 재출시 후 SCYNEXIS는 연간 순매출 이정표와 로열티를 합쳐 최대 미화 1억 4,550만 달러를 받을 수 있으며, Merck에 지불해야 하는 금액을 차감한 순지급으로, 비율은 낮은~중간 한 자릿수% 범위로 예상됩니다. 회사는 이 지불을 미래의 비희석 자본의 잠재적 원천으로 설명합니다.
SCYNEXIS (NASDAQ: SCYX) a finalisé le transfert du NDA de BREXAFEMME (ibrexafungerp) à GSK le 19 novembre 2025. GSK peut désormais engager des échanges réglementaires avec la FDA pour discuter d’un relancement américain de la candidose vulvo‑ vaginale (VVC) et de la VVC réfractaire (rVVC). Après ce relancement, SCYNEXIS peut percevoir jusqu’à 145,5 millions de dollars en étapes de ventes nettes annuelles plus des royalties, payable net des montants dus à Merck et attendus dans une fourchette à un chiffre inférieur à moyen pourcentage. L’entreprise décrit ces paiements comme une source potentielle de capital non dilutif à l’avenir.
SCYNEXIS (NASDAQ: SCYX) hat die Übertragung des NDA für BREXAFEMME (ibrexafungerp) an GSK am 19. November 2025 abgeschlossen. GSK kann nun regulatorische Kontakte mit der FDA aufnehmen, um einen US‑Relaunch der Vulvovaginalcandidose (VVC) und der refraktären VVC (rVVC) zu besprechen. Nach dem Relaunch könnte SCYNEXIS bis zu 145,5 Millionen US-Dollar an jährlichen Nettoumsatz‑Meilensteinen plus Royalties erhalten, zahlbar netto von Beträgen, die Merck zustehen, und erwartet im Bereich niedrige bis mittlere einstellige Prozentwerte. Das Unternehmen beschreibt diese Zahlungen als potenzielle Quelle nicht dilutiven Kapitals in der Zukunft.
SCYNEXIS (NASDAQ: SCYX) أكملت نقل NDA لـ BREXAFEMME (ibrexafungerp) إلى GSK في 19 نوفمبر 2025. يمكن لـ GSK الآن بدء التفاعل التنظيمي مع FDA لمناقشة إعادة إطلاق في الولايات المتحدة لـ عدوى المبيضات الفرجية (VVC) وVVC المقاومة (rVVC). عقب إعادة الإطلاق، ستكون SCYNEXIS مؤهلة للحصول على حتى 145.5 مليون دولار كمعالم للمبيعات الصافية السنوية بالإضافة إلى العوائد، التي ستُدفع صافي المبالغ المستحقة لـ Merck والمتوقعة في نطاق أرقام أحادية منخفضة إلى متوسطة بالنسبة المئوية. وتصف الشركة هذه المدفوعات بأنها مصدر محتمل لرأس المال غير المخفّض في المستقبل.
- Potential $145.5 million annual net-sales milestone opportunity
- Royalties payable in the low-to-mid single-digit percentage range
- Relaunch depends on GSK initiating FDA regulatory interactions
- Royalties reduced net of payments to Merck, lowering SCYNEXIS proceeds
- 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
FAQ
What did SCYNEXIS announce about the BREXAFEMME NDA on November 19, 2025?
How much can SCYNEXIS (SCYX) receive if GSK relaunches BREXAFEMME?
When can investors expect payments to SCYNEXIS (SCYX) related to BREXAFEMME?
Will SCYNEXIS (SCYX) receive immediate revenue from the NDA transfer?
Do Merck payments affect SCYNEXIS's BREXAFEMME royalties?
