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Relmada Therapeutics, Inc.: Business Overview, Financials & Competitive Analysis

Relmada Therapeutics, Inc. scores 7/10 on the AskCyborg Cyborg Score (Strong). Capital-efficient clinical-stage biotech with FDA-validated Phase 3 pathway and strong efficacy signals positioning NDV-01 for potential market entry. Jefferies initiated coverage with a "Buy" recommendation on December 22, 2025, and FDA provided written feedback supporting the registrational development pathway for NDV-01. The company demonstrated strong efficacy but faces typical.

What is Relmada Therapeutics, Inc.'s industry? Relmada Therapeutics, Inc. (relmada.com) operates in Biopharmaceutical / Clinical-Stage Biotechnology. AskCyborg classifies Relmada Therapeutics, Inc. under Biopharmaceutical / Clinical-Stage Biotechnology in its company registry.

Relmada Therapeutics operates as a clinical-stage biotechnology company, focusing on therapies for central nervous system (CNS) and metabolic disorders. Lead programs NDV-01 and sepranolone are positioned to reach key...

7/ 10Strong

Cyborg Score thesis

Capital-efficient clinical-stage biotech with FDA-validated Phase 3 pathway and strong efficacy signals positioning NDV-01 for...

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Industry Biopharmaceutical / Clinical-Stage Biotechnology
3 named competitors
4 recent developments
11 analyst dimensions
Synthesized from analyst-debate stress-testing across 11 dimensions and hundreds of data points. Methodology →
Cyborg Score recalibrated: September 7, 2026
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Relmada Therapeutics, Inc. OverviewStrategic ProfileCompetitive LandscapeIndustry ContextKey facts
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Relmada Therapeutics, Inc. Overview

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Relmada Therapeutics operates as a clinical-stage biotechnology company, focusing on therapies for central nervous system (CNS) and metabolic disorders. Lead programs NDV-01 and sepranolone are positioned to reach key clinical milestones in 2026.

Strategic Profile

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NDV-01 has demonstrated a 90% overall response rate in Phase 2a for non-muscle invasive bladder cancer (NMIBC), with a Phase 3 trial planned for the first half of 2026. Sepranolone, backed by promising data in Tourette syndrome, is progressing toward a Phase 2b trial in Prader-Willi syndrome. The company benefits from a seasoned leadership team, robust product exclusivity, and a strong financial foundation.

Competitive Landscape

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Relmada competes in the rare disease and oncology biotech space. Competitors include Astria Therapeutics, Sarepta Therapeutics, Neuphoria Therapeutics, and aTyr Pharma. The company's differentiation lies in its dual-indication pipeline (oncology and CNS) and validated regulatory pathways.

Industry Context

Relmada Therapeutics, Inc. operates in Biopharmaceutical / Clinical-Stage Biotechnology.

Key facts

Founded: 2004 · Headquarters: Coral Gables, Florida · Revenue: $0

What the analysts stress-tested

The top findings that survived the multi-agent debate for Relmada Therapeutics, Inc..

  • NDV-01 Phase 2 9-month follow-up showed 92% overall response anytime (23/25) and 85% complete response at 9 months with no progression to muscle-invasive disease
  • Regulatory update confirmed FDA alignment on registrational studies design for NDV-01 on January 12, 2026
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Recent developments

Material events tracked by the AskCyborg corpus.

  • January 2026FDA alignment confirmed on Phase 3 registrational study design for NDV-01
  • December 2025Jefferies initiated "Buy" coverage with positive outlook
  • +2 moreTrack every material event for Relmada Therapeutics, Inc. as it happens. Explore monitoring →
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Named competitors

Pulled from the analyst-debate framework. Click any competitor to see their Cyborg Score.

Gene Therapy for Rare Genetic DisordersLeading gene therapy developer for rare neuromuscular diseases→CNS TherapeuticsClinical-stage biotech focused on CNS rare diseases→Therapeutic ProteinsImmuno-oncology and rare disease focus→

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Industry context

Relmada Therapeutics, Inc. operates in Biopharmaceutical / Clinical-Stage Biotechnology. See how the rest of the sector scores on the Cyborg framework.

Top companies in Biopharmaceutical by Cyborg Score

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Frequently asked questions

What does Relmada Therapeutics, Inc. do?+
Relmada Therapeutics operates as a clinical-stage biotechnology company, focusing on therapies for central nervous system (CNS) and metabolic disorders. Lead programs NDV-01 and sepranolone are positioned to reach key...
What is Relmada Therapeutics, Inc.'s Cyborg Score?+
Relmada Therapeutics, Inc. has a Cyborg Score of 7/10 (Strong). The score synthesizes business model, financials, leadership, competitive position, technology, marketing, and ESG dimensions across hundreds of data points.
Who are Relmada Therapeutics, Inc.'s main competitors?+
Named competitors include Gene Therapy for Rare Genetic Disorders, CNS Therapeutics, Therapeutic Proteins. The full competitive landscape is in the AskCyborg report.
How can I get the full Relmada Therapeutics, Inc. research report?+
Get the report plus analyst-debate audio at askcyborg.com -- no credit card required for preview access. Pro adds saved-company audio playlists and monitoring.
How current is the Relmada Therapeutics, Inc. research?+
The Cyborg Score is recalibrated weekly. Recent developments are tracked continuously and surfaced in every report.

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