This section highlights FDA-related milestones and regulatory updates for drugs developed by SCYNEXIS (SCYX).
Over the past two years, SCYNEXIS has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ibrexafungerp and SCY-247. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ibrexafungerp - FDA Regulatory Timeline and Events
Ibrexafungerp is a drug developed by SCYNEXIS for the following indication: For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ibrexafungerp
- Announced Date:
- May 28, 2025
- Indication:
- For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC)
Announcement
SCYNEXIS, Inc. announced that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection.
AI Summary
SCYNEXIS, Inc. announced the resumption of patient dosing in its Phase 3 MARIO study after the FDA lifted a clinical hold. The study is testing oral ibrexafungerp as a potential step-down antifungal therapy after patients have received IV echinocandin for invasive candidiasis, a life-threatening infection. New clinical supplies were produced at a different site to address contamination concerns and meet updated FDA standards.
If the trial is successful and approved by the FDA, the new oral treatment could offer healthcare providers an important alternative to IV-only echinocandin therapies, improving patient care for invasive fungal infections. The restart of dosing also triggers a $10 million milestone payment from partner GSK, with an additional $20 million expected in six months, although there is a disagreement between the companies over these payments.
Read Announcement
SCY-247 - FDA Regulatory Timeline and Events
SCY-247 is a drug developed by SCYNEXIS for the following indication: For systemic fungal diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SCY-247
- Announced Date:
- April 8, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being held from April 11-15, 2025.
AI Summary
SCYNEXIS, Inc. announced that it will present new preclinical efficacy data on its second-generation antifungal candidate, SCY-247, at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) conference in Vienna from April 11-15, 2025. SCY-247 is being developed to tackle systemic fungal infections, including those where current treatments are failing due to resistance. The preclinical studies showcased at the event focus on SCY-247’s ability to fight multi drug-resistant fungi, such as Candida auris and other resistant Candida species. The data, presented in detailed poster sessions, highlights SCY-247’s robust activity against various resistant fungal pathogens, suggesting it could offer a new treatment option for difficult-to-treat infections. This development is a promising step forward in the fight against antifungal resistance and may pave the way for more effective treatments in the future.
Read Announcement - Drug:
- SCY-247
- Announced Date:
- March 12, 2025
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. Provides Corporate Update
AI Summary
SCYNEXIS, Inc. provided a corporate update focusing on its progress in developing innovative antifungal treatments. The company initiated a Phase 1 trial in December 2024 for SCY-247, its second-generation triterpenoid antifungal intended to treat severe invasive fungal infections. Early findings have been promising in preclinical studies, and SCYNEXIS expects to release detailed data on single and multiple ascending doses in Q3 2025. Presentations on preclinical results are scheduled at the 2025 ESCMID Global congress in Vienna.
The update also highlighted plans to restart the Phase 3 MARIO study for invasive candidiasis once the FDA lifts the current clinical hold, anticipated in the second quarter of 2025. With $75.1 million in cash, cash equivalents, and investments as of the end of 2024, SCYNEXIS projects funding to support its operations through Q3 2026.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- April 30, 2024
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced the presentation of preclinical efficacy data on its second generation fungerp candidate SCY-247 at the ESCMID Global 2024 congress (formerly known as ECCMID) in Barcelona, Spain from April 27-30, 2024.
AI Summary
SCYNEXIS, Inc. recently presented encouraging preclinical data on its second generation fungerp candidate, SCY-247, at the ESCMID Global 2024 congress in Barcelona from April 27-30, 2024. The data, delivered by Professor Nathan Wiederhold, showcased SCY-247’s efficacy in a mouse model of invasive candidiasis caused by Candida glabrata—an important pathogen noted for rising resistance. In the study, mice treated with SCY-247 showed a clear, dose-dependent reduction in fungal burden in the kidneys and lungs compared to the control group. The findings highlight not only the promising in vivo activity of SCY-247 but also its potential to overcome current challenges in treating invasive fungal infections, especially those involving drug-resistant strains. Overall, these results bolster confidence in SCY-247 as a strong candidate for further clinical development to address unmet needs in antifungal therapy.
Read Announcement- Drug:
- SCY-247
- Announced Date:
- April 9, 2024
- Indication:
- For systemic fungal diseases
Announcement
SCYNEXIS, Inc. announced the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain from April 27-30, 2024.
AI Summary
SCYNEXIS, Inc. recently showcased preclinical efficacy data for its second-generation triterpenoid antifungal candidate, SCY-247, at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain, held from April 27-30, 2024. The company presented both in vivo and in vitro findings demonstrating that SCY-247 has strong potential against systemic fungal diseases, particularly those caused by drug-resistant pathogens such as Candida glabrata and Candida auris.
The preclinical data revealed that SCY-247 significantly reduced fungal burdens in animal models in a dose-dependent manner and showed broad-spectrum activity against several fungal species, including azole-resistant strains. These encouraging results underline SCY-247’s promise as a novel treatment option for invasive fungal infections, addressing a critical need in the fight against difficult-to-treat and resistant fungal pathogens.
Read Announcement
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