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Relmada Therapeutics (RLMD) FDA Events

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FDA Events for Relmada Therapeutics (RLMD)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Relmada Therapeutics (RLMD). Over the past two years, Relmada Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NDV-01, REL-1017, and REL-1017. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Relmada Therapeutics' Drugs in FDA Review

NDV-01 - FDA Regulatory Timeline and Events

NDV-01 is a drug developed by Relmada Therapeutics for the following indication: For Non-Muscle Invasive Bladder Cancer. 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.

REL-1017 - FDA Regulatory Timeline and Events

REL-1017 is a drug developed by Relmada Therapeutics for the following indication: For the adjunctive treatment of major depressive disorder (MDD). 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.

REL-1017 Reliance II - FDA Regulatory Timeline and Events

REL-1017 Reliance II is a drug developed by Relmada Therapeutics for the following indication: For major depressive disorder (MDD). 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.

Relmada Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Relmada Therapeutics (RLMD) has reported FDA regulatory activity for the following drugs: NDV-01, REL-1017 Reliance II and REL-1017.

The most recent FDA-related event for Relmada Therapeutics occurred on April 28, 2025, involving NDV-01. The update was categorized as "Positive Data," with the company reporting: "Relmada Therapeutics, announced that positive initial data from the Phase 2 study of NDV-01 showed that 90% of patients achieved high-grade disease-free status at any time point following treatment, demonstrating strong clinical activity and supporting further development of NDV-01 for the treatment of non-muscle invasive bladder cancer (NMIBC)."

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

  • For Non-Muscle Invasive Bladder Cancer - NDV-01
  • For major depressive disorder (MDD) - REL-1017 Reliance II
  • For the adjunctive treatment of major depressive disorder (MDD). - REL-1017

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