Scynexis Receives FDA QIDP and FTD Designations
Scynexis announced that the U.S. Food and Drug Administration, FDA, has granted the Company Qualified Infectious Disease Product, QIDP, and Fast Track Designations, FTD, for its second-generation triterpenoid antifungal therapy, SCY-247. In 2026, the Company expects to initiate a Phase 1 study of SCY-247 with the IV formulation as well as a Phase 2 study with the oral formulation in invasive candidiasis. Scynexis also aims to release proof-of -concept data for the oral formulation of SCY-247 in IC in 2026. Considering the differentiated attributes of SCY-247 and its potential role to counter health security threats posed by antifungal resistance development, the company will also continue exploring potential non-dilutive funding opportunities to further support this program.
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SCYNEXIS Reports 2025 Financial Highlights and Pipeline Progress
- Significant Revenue Growth: SCYNEXIS reported total revenue of $20.6 million for 2025, a substantial increase from $3.7 million in 2024, primarily driven by licensing agreement revenue from GSK, indicating strong performance in the antifungal market.
- Narrowed Net Loss: The company posted a net loss of $8.6 million in 2025, significantly down from $21.3 million in 2024, reflecting effective cost control and revenue growth, which enhances investor confidence.
- SCY-247 Clinical Progress: SCY-247, a second-generation antifungal drug, is currently in Phase 1 clinical trials, with early results demonstrating good tolerability and strong pharmacokinetics, with topline data for the IV formulation expected in the second half of 2026.
- BREXAFEMME Relaunch Plans: Despite the recall of BREXAFEMME in 2023 due to manufacturing issues, GSK is preparing for its relaunch, and SCYNEXIS stands to gain up to $145.5 million in annual net sales milestones and royalties, further strengthening its financial stability.
SCYNEXIS Secures FDA QIDP Designation for SCY-247, Ensuring 10 Years of Market Exclusivity
- FDA Designation: SCYNEXIS's SCY-247 has received QIDP and Fast Track designations from the FDA, ensuring at least 10 years of market exclusivity post-approval, thereby enhancing the company's competitive edge in the antifungal market.
- Clinical Trial Plans: The company expects to initiate a Phase 1 study of SCY-247 with the IV formulation and a Phase 2 study with the oral formulation in 2026, aiming to address the treatment needs for invasive candidiasis and further advance product development.
- Antifungal Activity: SCY-247 has demonstrated potent activity against various difficult-to-treat fungal pathogens, including multi-drug-resistant Candida auris, in multiple preclinical studies, indicating its potential to combat public health threats.
- Market Demand: As the threat of multi-drug resistant fungal infections escalates, the development of SCY-247 not only meets the urgent market need for novel antifungal agents but also holds the potential for significant economic returns for the company.
Scynexis Reveals Federal Support for Partnership Between Hackensack Meridian CDI and Johns Hopkins Researchers to Create Innovative Therapies, Including New Fungerps, for Resistant Fungal Infections
Federal Grant Announcement: SCYNEXIS, Inc. has received a five-year federal grant of $7 million annually to support the development of new antifungal therapeutics, particularly next-generation triterpenoid antifungals (fungerps), aimed at combating resistant fungal infections.
Research Collaboration: The grant will establish a Center of Excellence in Translational Research (CETR) in collaboration with Hackensack Meridian Center for Discovery and Innovation and Johns Hopkins Bloomberg School of Public Health, focusing on advancing fungerp candidates from preclinical stages to IND-ready status.
Fungal Infection Statistics: Approximately four million deaths annually are attributed to fungal infections globally, highlighting the urgent need for new therapeutics to address the growing threat of resistant fungal pathogens.
Triterpenoid Antifungals Overview: Triterpenoid antifungals represent a novel class of glucan synthase inhibitors, with the first compound, Ibrexafungerp, already approved for treating vulvovaginal candidiasis, while additional candidates are in various stages of development to tackle multidrug-resistant fungal infections.
SCYNEXIS Announces Financial Results for Q3 2025 and Shares Corporate Update
Financial Agreement with GSK: SCYNEXIS will receive $24.8 million from GSK as part of resolving a disagreement over the Phase 3 MARIO study, which SCYNEXIS has agreed to terminate. This payment will enhance the company's cash runway to over two years.
SCY-247 Development Progress: Following positive Phase 1 results for SCY-247, SCYNEXIS plans to initiate a Phase 1 study for its IV formulation and a Phase 2 study for invasive candidiasis, with proof of concept data expected in 2026.
Commitment to BREXAFEMME®: GSK is focused on relaunching BREXAFEMME®, with plans to transfer the NDA by year-end, potentially leading to SCYNEXIS receiving up to $146 million in annual sales milestones and royalties.
Q3 2025 Financial Results: SCYNEXIS reported a net loss of $8.6 million for Q3 2025, with total revenue primarily from license agreements. The company is managing its expenses effectively, resulting in a cash balance of $37.9 million as of September 30, 2025.
Guggenheim Reiterates Buy Rating on SCYNEXIS, Adjusts Price Target to $3
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VTYX, MEDP, INBX Surge in After-Hours Trading Following Important Announcements
Ventyx Biosciences Surge: Ventyx Biosciences' shares skyrocketed over 88% after positive Phase 2 trial results for its obesity and cardiovascular risk treatment, VTX3232.
Medpace Holdings Performance: Medpace Holdings saw an 18% increase in shares following better-than-expected Q3 results and an updated fiscal year 2025 guidance.
Inhibrx Biosciences Update: Inhibrx Biosciences' shares rose over 10% as the company announced a live webcast to present topline results from its ChonDRAgon study on ozekibart for chondrosarcoma.
Other Notable Movers: Several biotech stocks, including Acumen Pharmaceuticals and SCYNEXIS, experienced significant after-hours gains, reflecting a broader positive trend in the sector.
SCYNEXIS Reports 2025 Financial Highlights and Pipeline Progress
- Significant Revenue Growth: SCYNEXIS reported total revenue of $20.6 million for 2025, a substantial increase from $3.7 million in 2024, primarily driven by licensing agreement revenue from GSK, indicating strong performance in the antifungal market.
- Narrowed Net Loss: The company posted a net loss of $8.6 million in 2025, significantly down from $21.3 million in 2024, reflecting effective cost control and revenue growth, which enhances investor confidence.
- SCY-247 Clinical Progress: SCY-247, a second-generation antifungal drug, is currently in Phase 1 clinical trials, with early results demonstrating good tolerability and strong pharmacokinetics, with topline data for the IV formulation expected in the second half of 2026.
- BREXAFEMME Relaunch Plans: Despite the recall of BREXAFEMME in 2023 due to manufacturing issues, GSK is preparing for its relaunch, and SCYNEXIS stands to gain up to $145.5 million in annual net sales milestones and royalties, further strengthening its financial stability.
SCYNEXIS Secures FDA QIDP Designation for SCY-247, Ensuring 10 Years of Market Exclusivity
- FDA Designation: SCYNEXIS's SCY-247 has received QIDP and Fast Track designations from the FDA, ensuring at least 10 years of market exclusivity post-approval, thereby enhancing the company's competitive edge in the antifungal market.
- Clinical Trial Plans: The company expects to initiate a Phase 1 study of SCY-247 with the IV formulation and a Phase 2 study with the oral formulation in 2026, aiming to address the treatment needs for invasive candidiasis and further advance product development.
- Antifungal Activity: SCY-247 has demonstrated potent activity against various difficult-to-treat fungal pathogens, including multi-drug-resistant Candida auris, in multiple preclinical studies, indicating its potential to combat public health threats.
- Market Demand: As the threat of multi-drug resistant fungal infections escalates, the development of SCY-247 not only meets the urgent market need for novel antifungal agents but also holds the potential for significant economic returns for the company.
Scynexis Reveals Federal Support for Partnership Between Hackensack Meridian CDI and Johns Hopkins Researchers to Create Innovative Therapies, Including New Fungerps, for Resistant Fungal Infections
Federal Grant Announcement: SCYNEXIS, Inc. has received a five-year federal grant of $7 million annually to support the development of new antifungal therapeutics, particularly next-generation triterpenoid antifungals (fungerps), aimed at combating resistant fungal infections.
Research Collaboration: The grant will establish a Center of Excellence in Translational Research (CETR) in collaboration with Hackensack Meridian Center for Discovery and Innovation and Johns Hopkins Bloomberg School of Public Health, focusing on advancing fungerp candidates from preclinical stages to IND-ready status.
Fungal Infection Statistics: Approximately four million deaths annually are attributed to fungal infections globally, highlighting the urgent need for new therapeutics to address the growing threat of resistant fungal pathogens.
Triterpenoid Antifungals Overview: Triterpenoid antifungals represent a novel class of glucan synthase inhibitors, with the first compound, Ibrexafungerp, already approved for treating vulvovaginal candidiasis, while additional candidates are in various stages of development to tackle multidrug-resistant fungal infections.
SCYNEXIS Announces Financial Results for Q3 2025 and Shares Corporate Update
Financial Agreement with GSK: SCYNEXIS will receive $24.8 million from GSK as part of resolving a disagreement over the Phase 3 MARIO study, which SCYNEXIS has agreed to terminate. This payment will enhance the company's cash runway to over two years.
SCY-247 Development Progress: Following positive Phase 1 results for SCY-247, SCYNEXIS plans to initiate a Phase 1 study for its IV formulation and a Phase 2 study for invasive candidiasis, with proof of concept data expected in 2026.
Commitment to BREXAFEMME®: GSK is focused on relaunching BREXAFEMME®, with plans to transfer the NDA by year-end, potentially leading to SCYNEXIS receiving up to $146 million in annual sales milestones and royalties.
Q3 2025 Financial Results: SCYNEXIS reported a net loss of $8.6 million for Q3 2025, with total revenue primarily from license agreements. The company is managing its expenses effectively, resulting in a cash balance of $37.9 million as of September 30, 2025.
Guggenheim Reiterates Buy Rating on SCYNEXIS, Adjusts Price Target to $3
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: Subscribers gain access to unique stories and insights generated by Benzinga reporters.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing their trading strategies.
Market Winning Tools: The platform is designed to help traders win in the markets every day with accurate stock market intelligence.
VTYX, MEDP, INBX Surge in After-Hours Trading Following Important Announcements
Ventyx Biosciences Surge: Ventyx Biosciences' shares skyrocketed over 88% after positive Phase 2 trial results for its obesity and cardiovascular risk treatment, VTX3232.
Medpace Holdings Performance: Medpace Holdings saw an 18% increase in shares following better-than-expected Q3 results and an updated fiscal year 2025 guidance.
Inhibrx Biosciences Update: Inhibrx Biosciences' shares rose over 10% as the company announced a live webcast to present topline results from its ChonDRAgon study on ozekibart for chondrosarcoma.
Other Notable Movers: Several biotech stocks, including Acumen Pharmaceuticals and SCYNEXIS, experienced significant after-hours gains, reflecting a broader positive trend in the sector.
