Relmada Therapeutics updates shareholders on strategic advancements and new clinical candidates for oncology and CNS disorders.
Quiver AI Summary
Relmada Therapeutics, Inc. has provided a letter to shareholders highlighting significant progress in 2025 as it expands its portfolio and continues developing its innovative therapies for oncology and central nervous system disorders. The company has initiated a strategic review, leading to the addition of two Phase 2 product candidates: NDV-01 for non-muscle invasive bladder cancer (NMIBC) and sepranolone for compulsivity disorders including Prader-Willi Syndrome (PWS). NDV-01 has shown promising results, with a 91% complete response rate in its Phase 2 study, and plans for a Phase 3 trial are underway for early 2026. Meanwhile, sepranolone is set to advance into a Phase 2 study for PWS next year. Relmada is optimistic about future developments and the potential impact of its therapies.
Potential Positives
- Relmada has added two differentiated Phase 2 product candidates, NDV-01 and Sepranolone, enhancing its portfolio and long-term value proposition.
- NDV-01 showed a 91% complete response rate in Phase 2 studies, indicating strong efficacy and the potential for it to become a transformative therapy for a significant number of patients with non-muscle invasive bladder cancer (NMIBC).
- The expertise of new team members, including a Chief Medical Officer for oncology and a Chair for the Clinical Advisory Board, strengthens Relmada's leadership and capabilities in advancing its oncology programs.
- Upcoming key milestones, including the initiation of a Phase 3 trial for NDV-01 and a Phase 2 study for Sepranolone, are on track for early 2026, suggesting active progress in their development pipeline.
Potential Negatives
- Potential regulatory risks associated with FDA engagement for both NDV-01 and sepranolone, which could impact development timelines and program viability.
- Significant reliance on upcoming clinical trial results for both products, indicating that failure to achieve expected outcomes may negatively affect the company's stock and investor confidence.
- Limited information on potential challenges related to drug supply for NDV-01 and sepranolone, which could hinder production and market launch if not adequately addressed.
FAQ
What are the recent developments at Relmada Therapeutics?
Relmada has added two Phase 2 product candidates, NDV-01 and sepranolone, to strengthen its portfolio for oncology and compulsivity disorders.
What are the key results of NDV-01's Phase 2 study?
NDV-01 showed a 91% complete response rate in treating non-muscle invasive bladder cancer, indicating its potential as a transformative therapy.
When will the Phase 3 trial for NDV-01 begin?
The Phase 3 registrational trial for NDV-01 is expected to initiate in the first half of 2026.
What is sepranolone being developed for?
Sepranolone is being developed as a treatment for compulsivity disorders, specifically targeting Prader-Willi Syndrome.
What are the upcoming milestones for Relmada Therapeutics?
Key milestones include upcoming Phase 2 results for NDV-01 and initiating the Phase 2 study for sepranolone in early 2026.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$RLMD Insider Trading Activity
$RLMD insiders have traded $RLMD stock on the open market 11 times in the past 6 months. Of those trades, 11 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $RLMD stock by insiders over the last 6 months:
- SERGIO TRAVERSA (Chief Executive Officer) has made 6 purchases buying 615,976 shares for an estimated $352,807 and 0 sales.
- CHUCK ENCE (CA and CO) purchased 228,961 shares for an estimated $103,330
- MAGED SHENOUDA (Chief Financial Officer) has made 3 purchases buying 200,000 shares for an estimated $97,208 and 0 sales.
- PAUL EDWARD KELLY (Chief Operating Officer) purchased 200,000 shares for an estimated $86,060
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$RLMD Hedge Fund Activity
We have seen 19 institutional investors add shares of $RLMD stock to their portfolio, and 29 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- VANGUARD GROUP INC removed 843,998 shares (-69.9%) from their portfolio in Q2 2025, for an estimated $506,651
- DRIEHAUS CAPITAL MANAGEMENT LLC added 740,006 shares (+inf%) to their portfolio in Q2 2025, for an estimated $444,225
- ACADIAN ASSET MANAGEMENT LLC removed 608,449 shares (-49.6%) from their portfolio in Q2 2025, for an estimated $365,251
- PALO ALTO INVESTORS LP removed 495,146 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $297,236
- TWO SIGMA ADVISERS, LP removed 262,900 shares (-91.3%) from their portfolio in Q2 2025, for an estimated $157,818
- CORIENT PRIVATE WEALTH LLC added 206,667 shares (+inf%) to their portfolio in Q2 2025, for an estimated $124,062
- TANG CAPITAL MANAGEMENT LLC removed 200,825 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $54,222
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
CORAL GABLES, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology-related and central nervous system indications, today issued a Letter to Shareholders from Sergio Traversa, Chief Executive Officer.
Dear Fellow Shareholders:
2025 has been a truly transformational year for Relmada Therapeutics. With the year now well into its second half, I am pleased to share an update on our recent progress and to thank you for your continued support.
Strategic Review and Portfolio Expansion
Earlier this year, we completed a comprehensive strategic review that reaffirmed our mission to develop life-changing treatments while building a diversified portfolio. As a result, we added two differentiated Phase 2 product candidates that significantly strengthen Relmada’s long-term value proposition:
- NDV-01, a sustained-release formulation of gemcitabine and docetaxel in development for non-muscle invasive bladder cancer (NMIBC)
- Sepranolone, being developed for compulsivity disorders such as Prader-Willi Syndrome (PWS)
NDV-01: Strong Phase 2 Results and Path to Phase 3
Six-month follow-up data from our Phase 2 study of NDV-01 demonstrated impressive results, with a 91% complete response (CR) rate at any time point following treatment. These findings build on the positive three-month data presented at the 2025 American Urological Association Annual Meeting and reinforce the potential of NDV-01 as a transformative, bladder-sparing therapy for NMIBC, a condition that affects approximately 600,000 patients in the U.S.
We are actively preparing to initiate a Phase 3 registrational trial in the first half of 2026 , with key activities underway including regulatory filings and manufacturing scale-up.
Strengthening the NDV-01 Program
To further support NDV-01, we added two experts in bladder cancer to the Relmada team:
Raj S. Pruthi, MD as Chief Medical Officer–Oncology
Yair Lotan, MD as Chair of the Clinical Advisory Board
Their expertise will be invaluable as we advance the program toward late-stage development.
Sepranolone: Advancing in Prader-Willi Syndrome
Positive proof-of-concept data in Tourette’s syndrome suggest that sepranolone may hold promise as a therapy for compulsive disorders. In the first half of 2026, we plan to initiate a Phase 2 study in PWS , a rare genetic disorder affecting 350,000–400,000 people worldwide and characterized by compulsive behaviors such as hyperphagia (obsessive eating). Preparations, including regulatory engagement and manufacturing activities, are underway.
Key Upcoming Milestones
NDV-01
- Phase 2 nine-month results (Q4 2025) and twelve months (Q1 2026)
- Product supply scale-up — 2H 2025
- U.S. IND clearance — 1H 2026
- Initiation of Phase 3 registrational trial — 1H 2026
Sepranolone
- FDA engagement and manufacturing activities — 2H 2025
- Initiation of Phase 2 PWS study — 1H 2026
Looking Ahead
As we begin the autumn season, we remain optimistic about Relmada’s future. The progress of NDV-01 and sepranolone, combined with the expertise of our strengthened team, positions us well for value creation through disciplined execution and capital-efficient development.
On behalf of the entire Relmada team, thank you for your continued trust and confidence. We look forward to keeping you updated on our progress in the months ahead.
Sincerely,
Sergio Traversa
Chief Executive Officer
Relmada Therapeutics, Inc.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology-related and central nervous system conditions. Lead candidates NDV-01 and sepranolone are advancing through mid-stage clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com .
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release/Shareholder Letter contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the potential for Relmada’s product candidates to progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, the potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for NDV-01, and sepranolone, or that future NDV-01, or sepranolone, clinical results will be acceptable to the FDA, failure to secure adequate NDV-10, or sepranolone, drug supply, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
[email protected]
Media Inquiries:
Corporate Communications
[email protected]
