SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247, a Second-Generation Fungerp Candidate for Invasive Fungal Infections
SCYNEXIS Advances Antifungal Development: SCYNEXIS, Inc. has completed the first cohort dosing in a Phase 1 trial for SCY-247, a second-generation antifungal aimed at treating severe invasive fungal infections, which shows promise against drug-resistant pathogens.
Potential FDA Designations: The company anticipates that SCY-247 may receive Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, highlighting its significance in addressing antimicrobial resistance in systemic fungal diseases.
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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.
SCYNEXIS Announces Encouraging Phase 1 Findings for Antifungal Candidate SCY-247
Positive Phase 1 Results: SCYNEXIS reported favorable Phase 1 results for its antifungal drug SCY-247, which showed good tolerability with only mild to moderate adverse events in a study of 88 healthy participants.
Improved Tolerability and Efficacy: SCY-247 demonstrated better tolerability and effective exposures against resistant Candida strains compared to the first-generation medication, supporting its further development.
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.
SCYNEXIS Announces Encouraging Phase 1 Findings for Antifungal Candidate SCY-247
Positive Phase 1 Results: SCYNEXIS reported favorable Phase 1 results for its antifungal drug SCY-247, which showed good tolerability with only mild to moderate adverse events in a study of 88 healthy participants.
Improved Tolerability and Efficacy: SCY-247 demonstrated better tolerability and effective exposures against resistant Candida strains compared to the first-generation medication, supporting its further development.
