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Soligenix (SNGX) FDA Events

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FDA Events for Soligenix (SNGX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Soligenix (SNGX). Over the past two years, Soligenix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HyBryte, MarVax, and SuVax. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Soligenix's Drugs in FDA Review

HyBryte - FDA Regulatory Timeline and Events

HyBryte is a drug developed by Soligenix for the following indication: In the treatment of cutaneous T-cell lymphoma (CTCL). 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.

MarVax - FDA Regulatory Timeline and Events

MarVax is a drug developed by Soligenix for the following indication: Against Marburg Marburgvirus Infection. 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.

SuVax - FDA Regulatory Timeline and Events

SuVax is a drug developed by Soligenix for the following indication: For the Prevention and Post-Exposure Prophylaxis. 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.

Soligenix FDA Events - Frequently Asked Questions

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

In the past two years, Soligenix (SNGX) has reported FDA regulatory activity for the following drugs: HyBryte, SuVax and MarVax.

The most recent FDA-related event for Soligenix occurred on July 8, 2025, involving HyBryte. The update was categorized as "Provided Update," with the company reporting: "Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones"

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

  • In the treatment of cutaneous T-cell lymphoma (CTCL) - HyBryte
  • For the Prevention and Post-Exposure Prophylaxis - SuVax
  • Against Marburg Marburgvirus Infection - MarVax

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:SNGX) was last updated on 7/9/2025 by MarketBeat.com Staff
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