Relmada Therapeutics, Inc. RLMD
Relmada Therapeutics, Inc. (Nasdaq: RLMD) is an oncology drug developer. Its lead program, NDV-01 (sustained-release intravesical gemcitabine/docetaxel), is in Phase 2 for non-muscle-invasive bladder cancer (high-risk BCG-unresponsive; intermediate-risk adjuvant). Its next catalyst on record is NDV-01: US IND filing (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: NDV-01 — US IND filing (2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| NDV-01 | high-risk NMIBC (Phase 2 in Israel; planned single-arm pivotal Phase 3 in 2nd-line BCG-unresponsive CIS) | device-combination | Phase 2 |
| sepranolone | Prader-Willi syndrome; Tourette syndrome; essential tremor | small molecule | Phase 2 |
| NDV-01 | intermediate-risk NMIBC, adjuvant (planned registrational Phase 3) | device-combination | Pre-clinical |
Recent results and decisions
- Nov 4, 2025positive 9-month Phase 2 follow-up: 92% (23/25) complete response at any time, 85% CR at 9 months, no Grade 3+ treatment-related AEs; BCG-unresponsive subgroup 91% (10/11) CR at any time.
9-month follow-up for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety
Filing - Nov 4, 2025n/a FDA Type B pre-IND feedback supports two registrational paths (single-arm trial in 2L BCG-unresponsive NMIBC; randomized adjuvant trial in intermediate-risk NMIBC) and requires no further non-clinical studies.
Further non-clinical studies are not required.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.