RELMADA THERAPEUTICS, INC.
RLMD evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for RLMD—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · RLMD
Relmada Therapeutics is a clinical-stage biotechnology company that, after discontinuing its lead program in 2024, has pivoted to in-licensing and acquiring new drug candidates, including NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome, with a focus on leveraging its clinical development capabilities.
Key risk: Clinical trial failure risk
BioSniper Score
Based on 5 of 6 signals
Market Cap
$461.9M
Cash Runway
64.9 moLead Asset
ndv-01 (Phase 3)Next Catalyst
Phase3_Topline · Jun 30, 2028Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 5 clinical trials · 3 catalysts for RELMADA THERAPEUTICS, INC..
Relmada Therapeutics is a clinical-stage biotechnology company that, after discontinuing its lead program in 2024, has pivoted to in-licensing and acquiring new drug candidates, including NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome, with a focus on leveraging its clinical development capabilities.
- Relmada discontinued its former lead program, REL-1017 (esmethadone), after a planned interim analysis in December 2024 indicated the trial was unlikely to succeed [sec · filed 2026-04-17].
- The company pivoted to a new strategy of in-licensing or acquiring clinical-stage assets, resulting in the acquisition of NDV-01 (a novel extended-delivery formulation of gemcitabine and docetaxel for NMIBC) and sepranolone (a synthetic neurosteroid for Prader-Willi syndrome and other indications) [sec · filed 2026-04-17].
- As of June 30, 2026, Relmada reported cash and equivalents of $11.3 million, net income of -$12.9 million, and shareholders' equity of $86.5 million [sec].
- The company completed a $100 million secondary offering in November 2025, which included a strategic investor, and its share price rose from a low of $0.24 in March 2025 to a post-financing high of $4.83 in December 2025 [sec · filed 2026-04-17].
- Key near-term milestones include IND clearance and Phase 3 trial initiation for NDV-01 in mid-2026, and initiation of a Phase 2 trial for sepranolone in PWS in mid-2026, with initial data from the NDV-01 Phase 3 trial expected by year-end 2026 [sec · filed 2026-04-17].
What works
- Relmada successfully executed a strategic pivot after the failure of its lead program, in-licensing two clinical-stage assets (NDV-01 and sepranolone) with early proof-of-concept data and potential for rapid advancement [sec · filed 2026-04-17].
- The company raised $100 million in a secondary offering at no discount to market price, including a strategic investor, providing capital to fund its new pipeline [sec · filed 2026-04-17].
- Sepranolone targets Prader-Willi syndrome, a market estimated at >$5 billion in the US alone, with a potential rapid development path due to low regulatory hurdles [sec · filed 2026-04-17].
- Management retained its core team despite challenging circumstances (penny stock price, low market cap) and added a notable new hire [sec · filed 2026-04-17].
What to weigh
- Relmada's former lead program, REL-1017, failed in a pivotal trial, leading to a comprehensive strategic review and a near-total pipeline reset [sec · filed 2026-04-17].
- The company's cash position as of June 30, 2026, was $11.3 million, which may be limited relative to the costs of advancing multiple Phase 2 and Phase 3 trials [sec].
- Both NDV-01 and sepranolone are still in early-to-mid-stage development, with no guarantee of success in pivotal trials [sec · filed 2026-04-17].
- The company's share price and market cap experienced extreme volatility, hitting a nadir of $0.24 per share (approx. $7 million market cap) in March 2025 [sec · filed 2026-04-17].
From the filings
Quoted directly from source documents.
Relmada's former lead program failed in a pivotal trial.
“a planned interim analysis of the more advanced pivotal trial of its lead pipeline candidate, REL -1017 , indicated that the trial was unlikely to succeed.”
SEC filings · April 17, 2026
Relmada raised $100 million in a secondary offering in November 2025.
“ultimately conducted a highly successful $100 million secondary offering at no discount to the market price and that included a prominent strategic investor”
SEC filings · April 17, 2026
Relmada's share price hit a low of $0.24 in March 2025.
“The Company's share price hit a nadir of 24 cents in March of 2025, corresponding to an approximately $7 million market cap”
SEC filings · April 17, 2026
Catalyst timeline
- 2028-06-30 · Phase3_Topline · ndv-01 — Phase 3 Topline: A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Mu — Topline results from a Phase 3 study of NDV-01 in BCG-unresponsive NMIBC patients are expected.
- 2029-11-01 · Phase3_Topline · ndv-01 — Phase 3 Topline: A Phase 3, Randomized Study Evaluating the Efficacy and Safety of NDV-01 Versus Observation in Parti — Topline results from a randomized Phase 3 study comparing NDV-01 to observation are expected.
- 2032-09-01 · Phase3_Topline · ndv-01 — Phase 3 Topline: A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasiv — Topline results from a Phase 3 study of NDV-01 in NMIBC participants are expected.
Risks & what to watch (4)›
Key risks
- Clinical trial failure risk — Both NDV-01 and sepranolone are in early-to-mid-stage development and may fail to meet efficacy or safety endpoints in pivotal trials [sec · filed 2026-04-17].
- Limited cash runway — Cash of $11.3M as of June 30, 2026, may be insufficient to fully fund multiple Phase 2/3 trials without additional financing [sec].
- Regulatory and manufacturing hurdles — NDV-01 requires FDA IND clearance and successful trial initiation; any delays could impact timelines [sec · filed 2026-04-17].
- Dependence on new pipeline — After the failure of REL-1017, the company's future depends entirely on the success of recently acquired assets [sec · filed 2026-04-17].
What to watch
- FDA IND clearance for NDV-01 and initiation of Phase 3 trials in NMIBC, expected mid-2026 [sec · filed 2026-04-17].
- Initiation of Phase 2 proof-of-concept study for sepranolone in Prader-Willi syndrome, expected mid-2026 [sec · filed 2026-04-17].
- Initial 3-month data from the NDV-01 Phase 3 high-risk BCG-unresponsive NMIBC trial, expected year-end 2026 [sec · filed 2026-04-17].
- Top-line data from the sepranolone Phase 2 PWS study, expected before year-end 2026 [sec · filed 2026-04-17].
Sources: Catalysts · SEC filings · SEC MD&A · Generated August 26, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
64.9 months
D/E 0.06 · 0% dilution
Lead: Phase 3
3 candidates
3 upcoming, next in ~670d
No insider transactions in the last 180 days
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
101
Total value held
$549.6M
| Holder | Shares | Value |
|---|---|---|
| janus henderson group plc | 22,127,724 | $153.8M |
| vanguard capital management llc | 6,153,140 | $42.8M |
| adage capital partners gp, l.l.c. | 4,763,158 | $33.2M |
| orbimed advisors llc | 4,715,864 | $32.8M |
| marshall wace, llp | 4,481,606 | $31.2M |
| millennium management llc | 3,907,265 | $27.2M |
| ra capital management, l.p. | 2,947,369 | $20.5M |
| ikarian capital, llc | 2,688,359 | $18.7M |
| driehaus capital management llc | 2,132,053 | $14.8M |
| polar capital holdings plc | 1,414,621 | $9.8M |
Showing top 10 of 101 institutional holders of RELMADA THERAPEUTICS, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 28, 2026- % of float
- 6.3%
- Days to cover
- 4.6
- Shares short
- 6,193,292
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
RLMD short interestGovernance
Frequently asked questions
What is the AI investment thesis for RELMADA THERAPEUTICS, INC.?
Relmada Therapeutics is a clinical-stage biotechnology company that, after discontinuing its lead program in 2024, has pivoted to in-licensing and acquiring new drug candidates, including NDV-01 for non-muscle invasive bladder cancer and sepranolone for Prader-Willi syndrome, with a focus on leveraging its clinical development capabilities.
What is RELMADA THERAPEUTICS, INC.'s lead drug candidate?
RELMADA THERAPEUTICS, INC.'s most advanced tracked candidate is ndv-01 (Phase 3) for Bladder (Urothelial, Transitional Cell) Cancer; Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive).
What is RELMADA THERAPEUTICS, INC.'s next catalyst?
RELMADA THERAPEUTICS, INC.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3 Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Mu" — expected June 30, 2028.
Who is the CEO of RELMADA THERAPEUTICS, INC.?
Dr. Sergio Traversa M.B.A., Pharm.D. is the chief executive officer of RELMADA THERAPEUTICS, INC. (RLMD).
Where is RELMADA THERAPEUTICS, INC. headquartered?
RELMADA THERAPEUTICS, INC. (RLMD) is headquartered in Coral Gables, FL, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.