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Company profile / RLMD

Relmada Therapeutics

Clinaptis stanceUnder review

No Clinaptis stance is published for this company yet.

Ticker
RLMD
Exchange
NASDAQ
Coverage
Standard profile
Updated
Aug 19, 2026
Oncology / Rare Disease / CNS

Clinical-stage biotechnology company focused primarily on NDV-01, a sustained-release intravesical gemcitabine/docetaxel formulation being developed for non-muscle invasive bladder cancer, with sepranolone providing additional rare-disease CNS optionality.

01 / Clinaptis view

The current read

Neutral / Under Review after reducing exposure. NDV-01 has generated unusually strong Phase 2 response and durability data in NMIBC and benefits from physician familiarity with intravesical Gem/Doce, while its sustained-release formulation could materially simplify administration.

  1. However, the thesis has shifted from clinical proof-of-concept toward development execution: manufacturing, regulatory execution and timely initiation of the registrational RESCUE program now matter more than incremental Phase 2 efficacy.
02 / Consensus gap

Where the market may differ

The market may still apply a legacy Relmada discount despite NDV-01 being mechanistically and clinically unrelated to REL-1017. The opportunity is that NDV-01 combines an already familiar Gem/Doce regimen with sustained intravesical exposure and a simplified administration approach.

Coverage state
Standard profile
What the review turns on
Key variable

NDV-01 CMC/regulatory execution and timely initiation of the Phase 3 RESCUE registrational program

Next catalyst

NDV-01 regulatory clearance and initiation of the Phase 3 RESCUE registrational program

03 / Pipeline

Key programs

2 assets · 2 programs

AssetIndicationStageNext event
NDV-01
Non-Muscle Invasive Bladder Cancer (NMIBC)
Phase 2 / Phase 3 Registrational Development
Regulatory clearance and initiation of the RESCUE registrational program
Sepranolone
Prader-Willi Syndrome
Phase 2-Ready
Initiation of Phase 2 clinical development
04 / Connected research

Published on RLMD

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