SCYNEXIS Receives $22 Million Payment to Wind Down MARIO Study

SCYNEXIS Secures Financial Agreement with GSK
SCYNEXIS, Inc. (NASDAQ: SCYX), a forward-thinking biotechnology company, has reached a significant resolution with GlaxoSmithKline (GSK) regarding the Phase 3 MARIO study on invasive candidiasis. Under this agreement, SCYNEXIS is set to receive a $22 million payment that facilitates the wind-down process of the MARIO study.
Immediate Actions and Strategic Financial Planning
In light of this resolution, SCYNEXIS will rapidly implement the necessary steps to terminate the MARIO study. The receipt of this payment from GSK, in conjunction with available cash reserves and the cessation of future expenses related to the MARIO study, effectively extends the company’s financial runway to over two years.
Commitment to BREXAFEMME and Collaborative Efforts
GSK has reaffirmed its commitment to work alongside SCYNEXIS in furthering the commercialization of BREXAFEMME (ibrexafungerp tablets), particularly concerning vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC). SCYNEXIS is actively engaged in transferring the BREXAFEMME New Drug Application (NDA) to GSK, aiming for completion by 2025. GSK has indicated plans to commence discussions with the U.S. Food and Drug Administration (FDA) in 2026 regarding the relaunch of BREXAFEMME targeting the U.S. market.
Continued Focus on Antifungal Innovations
David Angulo, M.D., President and CEO of SCYNEXIS, expressed his sentiments regarding the resolution, mentioning the disappointment about the discontinuation of the MARIO study but also highlighting the company’s ongoing commitment to developing cutting-edge antifungal therapies. One promising candidate is SCY-247, a second-generation triterpenoid antifungal designed to treat and prevent invasive fungal infections, potentially offering both oral and intravenous treatment options.
Sincere Appreciation for Study Contributions
Dr. Angulo acknowledged the invaluable contributions of patients and investigators who participated in the MARIO study, underscoring their role in advancing the search for new antifungal agents that target areas of significant unmet medical needs.
About SCYNEXIS and Its Mission
SCYNEXIS, Inc. (NASDAQ: SCYX) is dedicated to pioneering innovative medicines aimed at helping patients combat challenging infections, particularly those that are increasingly resistant to existing treatments. Through its proprietary antifungal platform known as "fungerps," the company has made strides in developing novel antifungal agents. Ibrexafungerp, the first drug from this innovative class, received FDA approval in June 2021 for the treatment of VVC, with a second indication added for managing recurrent VVC in November 2022. The company is also exploring additional antifungal therapies at various stages of clinical and pre-clinical development.
Frequently Asked Questions
What is the significance of the $22 million payment from GSK?
This payment allows SCYNEXIS to efficiently wind down the Phase 3 MARIO study and extends their financial runway significantly.
What will happen to the MARIO study?
SCYNEXIS will promptly terminate the MARIO study following the resolution with GSK.
What is BREXAFEMME and who is responsible for its commercialization?
BREXAFEMME (ibrexafungerp tablets) is an antifungal medication, and GSK is committed to its commercialization for addressing VVC and rVVC.
How does SCYNEXIS plan to use the funds received?
SCYNEXIS intends to utilize the funds to support ongoing operations and continue developing promising antifungal treatments like SCY-247.
What are SCYNEXIS's future plans regarding product development?
SCYNEXIS aims to transfer the BREXAFEMME NDA to GSK and further advance their pipeline of antifungal agents to address unmet medical needs.
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