Relmada Therapeutics

What Relmada Therapeutics does

Relmada Therapeutics is a clinical-stage biotechnology company developing therapies for oncology and central nervous system disorders, traded on NASDAQ under ticker RLMD and headquartered in Coral Gables, Florida. Its lead asset, NDV-01, is a sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) engineered for non-muscle invasive bladder cancer (NMIBC); the formulation enables approximately 10 days of controlled local drug release and in-office administration in under 5 minutes without anesthesia. NDV-01 reported 76% complete response at 12 months and 95% CR at any time in high-risk NMIBC patients, with 80% CR at 12 months in BCG-unresponsive disease and no observed progression to muscle-invasive disease; the program has FDA alignment on two registrational pathways (2L BCG-unresponsive and adjuvant intermediate-risk) and is advancing into the Phase 3 RESCUE registrational trial expected to initiate mid-2026. A provisional patent filed in April 2026 could extend exclusivity through 2047 if granted.

The company's second program, sepranolone, is a synthetic isoallopregnanolone that selectively antagonizes allopregnanolone at GABA-A receptors without broadly disrupting GABAergic signaling; it targets compulsive behaviors in Prader-Willi syndrome, Tourette syndrome, and OCD, with a Phase 2 trial in Prader-Willi expected mid-2026. Both assets were in-licensed or acquired in 2025 (NDV-01 from Trigone Pharma; sepranolone from Sweden-based Asarina Pharma AB), marking a strategic pivot following prior Phase 3 setbacks with REL-1017 in major depressive disorder. The business model is pre-revenue: there are no approved products and no product sales, and the company funds operations through equity financings — approximately $410M raised across a December 2021 $150M public offering, a November 2025 $100M offering, and a March 2026 $160M PIPE with RA Capital, OrbiMed, Janus Henderson, and Venrock. The company reported $234M in cash as of March 31, 2026, with management stating runway through 2029, a $57.4M net loss for full-year 2025, and a Q1 2026 net loss of $19.1M. Future commercialization of NDV-01 is planned through specialty pharmacy networks serving academic and community urology practices.

Name

Relmada Therapeutics

Legal name

Relmada Therapeutics, Inc.

Website

https://relmada.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

Relmada Therapeutics is a clinical-stage biotechnology company developing NDV-01, a sustained-release intravesical formulation for non-muscle invasive bladder cancer, and sepranolone, a GABA-A receptor modulator for CNS disorders including Prader-Willi syndrome, Tourette syndrome, and OCD.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals

NAICS

Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

akta.pro secondary industry

Gene Therapy for Rare/Monogenic Diseases (HLAAACAE)

Keywords

• Clinical-stage biotechnology
• Bladder cancer therapy
• CNS disorder treatment
• Pharmaceutical drug development
• Intravesical drug delivery

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage biotechnology company. Intends to commercialize NDV-01 for non-muscle invasive bladder cancer and sepranolone for CNS disorders including Prader-Willi syndrome, Tourette syndrome, and OCD upon regulatory approval.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Relmada Therapeutics is a clinical-stage biotechnology company developing two lead product candidates: NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer (NMIBC) advancing toward a Phase 3 registrational program, and Sepranolone, a GABAA receptor modulator targeting compulsive behaviors in CNS disorders including Prader-Willi syndrome, Tourette syndrome, and OCD. The company has no approved or commercial products and is pre-revenue.

Product overview

Relmada Therapeutics is a clinical-stage biotechnology company developing two lead product candidates: NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer advancing into Phase 3 trials, and sepranolone, a GABAA receptor modulator targeting compulsive behaviors in CNS disorders including Prader-Willi syndrome. The company focuses on oncology and central nervous system disorders with an emphasis on delivering durable efficacy, favorable safety, and real-world usability.

Differentiator

Problem solved

Functional benefit

Products and services

• NDV-01 A sustained-release intravesical formulation of gemcitabine and docetaxel (Gem/Doce) for the treatment of non-muscle invasive bladder cancer (NMIBC). Engineered for prolonged bladder retention and controlled drug release over approximately 10 days, enabling streamlined in-office administration in under 5 minutes without anesthesia or specialized equipment. Targets high-risk NMIBC patients who failed BCG therapy and intermediate-risk NMIBC patients in adjuvant setting.
• Sepranolone A synthetic isoallopregnanolone that selectively antagonizes allopregnanolone (ALLO) at GABA-A receptors without disrupting general GABA signaling. Targets disorders linked to excess GABAergic activity including Prader-Willi syndrome, Tourette syndrome, and obsessive-compulsive disorder (OCD). Prior clinical and preclinical data support effects on food craving, appetite and compulsive behaviors.

Quantifiable outcome

• 76% complete response rate at 12 months in high-risk NMIBC patients
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Five partnerships are on record, tiered core, key advisor and investor relations.

• Asarina Pharma ABcoreTechnology or Integration · 1 February 2025Relmada acquired sepranolone, a Phase 2b-ready neurosteroid targeting GABA-A receptors, from Sweden-based Asarina Pharma AB in February 2025. Sepranolone targets compulsive behaviors for disorders including Prader-Willi syndrome, Tourette syndrome, and OCD. The acquisition expanded Relmada's CNS disorder portfolio.
• Trigone Pharma Ltd.coreTechnology or IntegrationRelmada licensed NDV-01, a Phase 2 bladder cancer candidate, from Trigone Pharma. NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. This license agreement was key to Relmada's strategic pivot into oncology.
• Michael Quirk, PhDkey advisorOthersAppointed as Senior Advisor for sepranolone program in June 2026. Dr. Quirk brings over 20 years of neuroscience drug discovery experience, having served as Chief Scientific Officer and interim Head of R&D at Sage Therapeutics.
• Raj S. Pruthi, MDkey advisorOthersChief Medical Officer of Relmada Therapeutics - Urology. Appointed to lead development of cancer treatment programs. Also serves on PreveCeutical Medical's board.
• LifeSci Advisorsinvestor relationsOthersInvestor relations contact for Relmada. Brian Ritchie from LifeSci Advisors serves as the primary IR contact for the company.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Marinus Pharmaceuticals: Developer of Ztalmy (ganaxolone), a neurosteroid acting on GABA-A receptors approved for seizures associated with CDKL5 deficiency disorder. Direct CNS neurosteroid peer comparable to sepranolone's GABA-A mechanism.
• CG Oncology: Clinical-stage biotech developing cretostimogene, an intravesical gene therapy for BCG-unresponsive NMIBC. Directly comparable to Relmada's NDV-01 program targeting the same patient population with overlapping treatment settings.
• ImmunityBio: Developer of Anktiva (nogapendekin alfa), an IL-15 superagonist approved for BCG-unresponsive NMIBC. Direct competitor to NDV-01 in the same NMIBC treatment space with established regulatory and commercial footprint.
• Ferring Pharmaceuticals: Developer of Adstiladrin (nadofaragene), an intravesical gene therapy approved for BCG-unresponsive NMIBC. Direct competitor to NDV-01 with similar mechanism of local bladder delivery in the same indication.
• Sage Therapeutics: Developer of Zurzuvae (zuranolone), a neurosteroid acting on GABA-A receptors approved for postpartum depression. Closely comparable to sepranolone's GABA-A modulation mechanism; Senior Advisor Michael Quirk joined Relmada from Sage.

Broad incumbents

• Merck & Co. Large pharmaceutical company with KEYTRUDA (pembrolizumab) approved for BCG-unresponsive NMIBC. Competes with NDV-01 in the same indication but as part of a broader oncology portfolio rather than a focused NMIBC asset.
• Bristol Myers Squibb: Major oncology incumbent with Opdivo and a broad bladder cancer franchise. Competes in NMIBC and broader oncology but is a broad-line pharmaceutical player rather than a focused biotech.
• Johnson & Johnson: Diversified healthcare incumbent with significant oncology and CNS franchises. Represents the strategic acquirer profile relevant to clinical-stage biotechs like Relmada, though not a direct product competitor in NMIBC.
• Pfizer: Large pharmaceutical company with deep oncology and CNS pipelines. Relevant as a potential strategic acquirer and broad industry peer, but does not directly compete in NMIBC or sepranolone's CNS indications.

Others

• Asarina Pharma: Swedish biotech from which Relmada acquired sepranolone in February 2025. Adjacent technology originator with prior expertise in sepranolone's GABA-A mechanism for CNS disorders.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/relmada
• Facebookfacebook.com/relmadatherapeutics
• LinkedInlinkedin.com/company/relmada-therapeutics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds12 records

Investors18 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Relmada Therapeutics