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SCYNEXIS (SCYX) FDA Events

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FDA Events for SCYNEXIS (SCYX)

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.

SCYNEXIS's Drugs in FDA Review

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.

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.

SCYNEXIS FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, SCYNEXIS (SCYX) has reported FDA regulatory activity for the following drugs: SCY-247 and Ibrexafungerp.

The most recent FDA-related event for SCYNEXIS occurred on May 28, 2025, involving Ibrexafungerp. The update was categorized as "Dosing Update," with the company reporting: "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."

Current therapies from SCYNEXIS in review with the FDA target conditions such as:

  • For systemic fungal diseases - SCY-247
  • For the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) - Ibrexafungerp

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:SCYX) was last updated on 7/9/2025 by MarketBeat.com Staff
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