Relmada Therapeutics to Present NDV-01 Abstracts at AUA2026
Rhea-AI Summary
Relmada Therapeutics (Nasdaq: RLMD) will present two abstracts on NDV-01 at AUA2026 in Washington D.C., May 15-18, 2026. A 12-month Phase 2 update in high-risk NMIBC will be presented May 15, and a Phase 3 overview (RESCUE program) will appear in a Trials-in-Progress session May 17.
The company said the Phase 3 RESCUE registrational program remains on track to be initiated mid-2026. Exact presentation times and locations may change.
AI-generated analysis. Not financial advice.
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News Market Reaction – RLMD
On the day this news was published, RLMD declined 0.81%, reflecting a mild negative market reaction. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $7M from the company's valuation, bringing the market cap to $837.02M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
RLMD fell 3.01% while key biotech peers were mostly positive (e.g., ATNM +6.19%, FGEN +5.2%, SER +4.4%). With no peers in the momentum scanner and mixed but generally positive peer moves, the action appears stock-specific rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 19 | Earnings & update | Positive | -2.9% | Fourth-quarter results plus strong NDV‑01 Phase 2 data and financing runway. |
| Mar 12 | Earnings date notice | Neutral | -2.7% | Announcement of upcoming Q4 2025 earnings call and webcast logistics. |
| Mar 09 | Conference appearance | Neutral | -7.7% | Participation in Leerink healthcare conference with a fireside chat and meetings. |
| Mar 09 | Private placement | Positive | +61.1% | Oversubscribed $160.0 million private placement to fund R&D and operations. |
| Mar 09 | Clinical trial data | Positive | +61.1% | Strong NDV‑01 12‑month Phase 2 data in high‑risk NMIBC with high CR rates. |
RLMD saw sharp positive moves on NDV-01 data and financing, but mild declines around earnings and corporate updates, indicating the strongest reactions have followed major clinical and capital-raising milestones.
Over the past months, Relmada highlighted NDV-01 as its lead growth driver, with 12‑month Phase 2 data showing high complete response rates in high‑risk NMIBC and plans for the Phase 3 RESCUE program by mid-2026. A large $160.0 million private placement and subsequent resale registration supported this pivot. Earnings and conference appearances in March 2026 saw modest negative reactions, while the financing and NDV‑01 data on Mar 9 produced a strong +61.12% move. Today’s AUA presentation update fits into this ongoing NDV‑01 development narrative.
Regulatory & Risk Context
An effective S-3 shelf dated 2026-04-03 registers 33,685,096 existing and warrant-linked shares for resale by selling stockholders. The filing states the company will receive no proceeds from these resales, though it may receive proceeds from warrant exercises. A related 424B3 prospectus was filed on 2026-04-09.
Market Pulse Summary
This announcement highlights upcoming NDV‑01 presentations at AUA2026, including 12‑month Phase 2 data in high‑risk NMIBC and a Phase 3 BOOST trial-in-progress overview, while confirming the RESCUE registrational program remains on track for mid-2026. In recent months, Relmada has emphasized NDV‑01’s strong interim results and secured a $160.0 million financing alongside an effective S-3 resale registration. Investors may watch for detailed durability data, Phase 3 design specifics, and regulatory feedback as key next catalysts.
Key Terms
phase 2 medical
phase 3 medical
non-muscle invasive bladder cancer medical
intravesical medical
gemcitabine medical
docetaxel medical
registrational regulatory
trial in progress medical
AI-generated analysis. Not financial advice.
- 12-Month Phase 2 data in High-Risk NMIBC to be presented Friday, May 15, 2026
- Phase 3 overview to be presented at Trials-in-Progress session on Sunday, May 17, 2026
- The Phase 3 “RESCUE” registrational program remains on track to be initiated mid-2026
CORAL GABLES, Fla., May 05, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced the presentation of two abstracts related to NDV-01 at the American Urology Association (AUA2026), taking place from May 15-18th in Washington D.C.
Abstract Overview*
Abstract #1: Poster presentation: IP02-03: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 9-month Complete Response Data
- Session: IP02: Bladder Cancer: Non-Invasive I
- Location: Room 146A, Walter E. Washington Convention Center
- Presentation Date: Friday, May 15, 2026
- Presentation Time: 7:00 AM to 9:00 AM ET
Abstract #2: Oral presentation: Trial in Progress: REL-NDV01-301 (BOOST) - A Phase 3, Randomized Study of Adjuvant Intravesical Sustained-Release Gemcitabine-Docetaxel (NDV-01) Versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer.
- Session: Clinical Trials in Progress: Bladder Cancer
- Location: Hall B, The Square, Learning Lab, Walter E. Washington Convention Center
- Presentation Date: Sunday, May 17, 2026
- Presentation Time: 9:56 AM to 10:04 AM ET
*Exact conference presentation times and locations may be subject to change.
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is ready to use, convenient to administer in-office in less than 5 minutes and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About the Phase 2 Study
The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with high-grade non-muscle invasive bladder cancer (HG-NMIBC). Patients are treated with NDV-01 in a biweekly induction phase, followed by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).
About NMIBC
NMIBC represents 75
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its 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 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 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, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or 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 continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, 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 are not a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
