Relmada Therapeutics (RLMD) — Stock, Pipeline & Market Cap

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RLMD · Stock Price

USD 7.32+6.92 (+1739.20%)

Market Cap: $784.1M

Historical price data

Market Cap: $784.1MPipeline: 11 drugs (6 Phase 3)Patents: 7Founded: 2004HQ: Coral Gables, United States

Sector Ranking#195 in Small Molecule Drugs #59 in Oncology (General)

Overview

Relmada Therapeutics is executing a capital-efficient, late-stage development strategy with a focused pipeline targeting high-need areas in oncology and CNS. Its lead asset, NDV-01, has demonstrated a 90% overall response rate in a Phase 2a trial for non-muscular invasive bladder cancer (NMIBC), with a Phase 3 trial planned for H1 2026. Backed by an experienced leadership team and strengthened by a recent $160 million private placement, Relmada is positioned to reach key clinical milestones for NDV-01 and its CNS candidate, sepranolone, in Prader-Willi syndrome.

OncologyCentral Nervous System

Technology Platform

Relmada employs a rational development strategy focused on innovative drug delivery (sustained-release intravesical matrix) and novel neurosteroid modulation rather than a single proprietary discovery platform.

Pipeline

11

11 drugs in pipeline6 in Phase 3

Drug	Indication	Stage
REL-1017 + Placebo	Major Depressive Disorder	Phase 3
REL-1017 + Placebo	Major Depressive Disorder	Phase 3
NDV-01 (sustained-release gemcitabine-docetaxel)	Bladder (Urothelial, Transitional Cell) Cancer	Phase 3
NDV-01 (sustained-release gemcitabine-docetaxel)	Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)	Phase 3
NDV-01 (sustained-release gemcitabine-docetaxel)	Bladder (Urothelial, Transitional Cell) Cancer	Phase 3

Opportunities

NDV-01 addresses a large, underserved market in NMIBC with a convenient, potentially best-in-class therapy, while sepranolone offers a first-in-class approach for the core symptoms of Prader-Willi syndrome, a rare disease with no approved pharmacotherapy.

The recent $160M financing provides a multi-year runway to reach these key value inflection points.

Risk Factors

The company's value is highly concentrated in the success of NDV-01's upcoming Phase 3 trial; failure would be catastrophic.

Additional risks include regulatory hurdles, future dilution from capital needs, and intense competition in the evolving bladder cancer treatment landscape.

Competitive Landscape

In NMIBC, NDV-01 primarily competes with the standard-of-care BCG (plagued by shortages) and other intravesical chemotherapies/immunotherapies; its sustained-release, single-administration profile is a key differentiator. In PWS, sepranolone faces a nascent landscape with no approved drugs for hyperphagia, competing against early-stage metabolic and behavioral therapies.