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Dermata Therapeutics (DRMAW) FDA Events

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FDA Events for Dermata Therapeutics (DRMAW)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Dermata Therapeutics (DRMAW). Over the past two years, Dermata Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as DMT310 and XYNGARI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Dermata Therapeutics' Drugs in FDA Review

DMT310 - FDA Regulatory Timeline and Events

DMT310 is a drug developed by Dermata Therapeutics for the following indication: For the treatment of acne. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

XYNGARI - FDA Regulatory Timeline and Events

XYNGARI is a drug developed by Dermata Therapeutics for the following indication: Spongilla Treatment for Acne. 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.

Dermata Therapeutics FDA Events - Frequently Asked Questions

Yes, Dermata Therapeutics (DRMAW) has received FDA approval for DMT310. This page tracks recent and historical FDA regulatory events related to Dermata Therapeutics' drug portfolio.

In the past two years, Dermata Therapeutics (DRMAW) has reported FDA regulatory activity for the following drugs: XYNGARI and DMT310.

The most recent FDA-related event for Dermata Therapeutics occurred on March 27, 2025, involving XYNGARI. The update was categorized as "Top-line results," with the company reporting: "Dermata Therapeutics, Inc. announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne."

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

  • Spongilla Treatment for Acne - XYNGARI
  • For the treatment of acne - DMT310

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:DRMAW) was last updated on 7/10/2025 by MarketBeat.com Staff
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