Relmada Therapeutics Announces Presentation of NDV-01 Phase 2 Data at the Society for Urologic Oncology

Rhea-AI Summary

Relmada Therapeutics (Nasdaq: RLMD) will present 6-month follow-up data from its ongoing Phase 2 study of NDV-01, a sustained‑release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), at the Society of Urologic Oncology 26th Annual Meeting on Dec 4, 2025 (Poster #143, 2:30 PM MT).

The company reported favorable overall safety at six months, highlighted a previously announced 92% complete response (CR) rate at any time point in 9‑month data, and said it plans to advance NDV-01 into Phase 3 studies in two NMIBC indications in H1 2026. Relmada is targeting high‑risk and intermediate‑risk NMIBC, which it says represent about 80% of new NMIBC cases (~54,000 people in the US annually). A copy of the poster will be posted on Relmada's Events page after the session.

Positive

• 9-month data showed a 92% complete response (CR) rate
• Reported favorable overall safety at 6-month follow-up
• Plans to initiate Phase 3 program in H1 2026 in two NMIBC indications
• Targets high‑risk and intermediate‑risk NMIBC (~54,000 US patients annually)

Negative

• None.

News Market Reaction

+0.50%

6 alerts

+0.50% News Effect

+6.8% Peak Tracked

-12.5% Trough Tracked

+$2M Valuation Impact

$312M Market Cap

0.2x Rel. Volume

On the day this news was published, RLMD gained 0.50%, reflecting a mild positive market reaction. Argus tracked a peak move of +6.8% during that session. Argus tracked a trough of -12.5% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $312M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Complete response rate: 92% CR at any time point Follow-up duration: 6-month follow-up Target population share: 80% of new NMIBC cases +5 more

8 metrics

Complete response rate 92% CR at any time point NDV-01 9-month Phase 2 data in NMIBC

Follow-up duration 6-month follow-up Ongoing Phase 2 NDV-01 trial poster data

Target population share 80% of new NMIBC cases High- and intermediate-risk NMIBC focus

U.S. patients 54,000 people per year Estimated new NMIBC cases in the United States annually

Phase 3 timing H1 2026 Planned start of NDV-01 Phase 3 studies in two indications

Poster number #143 Society for Urologic Oncology 26th Annual Meeting

Presentation time 2:30 PM MT Poster session on Thursday, December 4th

Meeting edition 26th Annual Meeting Society for Urologic Oncology conference

Market Reality Check

Price: $3.96 Vol: Volume 1,786,957 is 1.58x...

high vol

$3.96 Last Close

Volume Volume 1,786,957 is 1.58x the 20-day average, indicating elevated trading interest before this update. high

Technical Shares at $4.19 are trading above the $1.26 200-day MA and about 18.16% below the 52-week high.

Peers on Argus

RLMD showed a positive move while key peers were mixed: VTVT and SER were down, ...

1 Down

RLMD showed a positive move while key peers were mixed: VTVT and SER were down, ATNM and VERU were modestly up, and FGEN was slightly down, pointing to stock-specific interest rather than a broad biotech move.

Historical Context

5 past events · Latest: Dec 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Clinical data update	Positive	+0.5%	Poster presentation of 6-month NDV-01 Phase 2 data with favorable safety.
Nov 13	Earnings and pipeline	Positive	-0.8%	Q3 2025 results plus NDV-01 9-month data and FDA-aligned Phase 3 paths.
Nov 07	Earnings date notice	Neutral	+1.5%	Announcement of timing and access details for the Q3 2025 earnings call.
Nov 04	Equity offering	Neutral	+25.9%	Pricing of $100M common stock and pre-funded warrant offering at $2.20.
Nov 04	Regulatory feedback	Positive	+25.9%	FDA feedback endorsing two registrational Phase 3 paths plus strong Phase 2 NDV-01 data.

Pattern Detected

RLMD has often reacted strongly to major NDV-01 and financing milestones, but reactions to positive clinical and regulatory news have been mixed, including one sharp selloff on earlier Phase 2 data.

Recent Company History

Over the past months, RLMD has focused on NDV-01 for NMIBC and shoring up its balance sheet. On Nov 4, 2025, FDA feedback supported two Phase 3 paths with strong Phase 2 efficacy, and an underwritten offering the same day raised about $100M. Q3 2025 results on Nov 13 highlighted a 92% anytime CR rate and extended cash runway. Today’s 6‑month Phase 2 poster presentation continues that NDV-01 clinical narrative toward planned Phase 3 starts in H1 2026.

Market Pulse Summary

This announcement reinforces NDV-01 as RLMD’s lead value driver, showcasing 6‑month Phase 2 data in ...

Analysis

This announcement reinforces NDV-01 as RLMD’s lead value driver, showcasing 6‑month Phase 2 data in NMIBC and a clear plan to enter Phase 3 in H1 2026. Historically, NDV-01 updates and FDA feedback have driven sizeable price moves, both positive and negative. Investors may focus on durability of the reported 92% complete response rate, the large target population of about 54,000 U.S. patients annually, and timely Phase 3 trial execution.

Key Terms

phase 2, phase 3, non-muscle invasive bladder cancer, intravesical, +4 more

8 terms

phase 2 medical

"6-month follow-up data from the ongoing Phase 2 trial of NDV-01 in non-muscle"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 3 medical

"Relmada plans to advance NDV-01... into Phase 3 studies in two indications in H1 2026"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

non-muscle invasive bladder cancer medical

"NDV-01... in development for non-muscle invasive bladder cancer (NMIBC)"

A form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it like a stain on wallpaper rather than damage to the wall’s studs. It matters to investors because it has different treatment, monitoring and recurrence patterns than deeper cancers, driving demand for repeated outpatient procedures, local therapies and diagnostic tests that affect revenue, trial design and pricing dynamics in healthcare markets.

intravesical medical

"a sustained release intravesical formulation of gemcitabine/docetaxel (Gem/Doce)"

Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.

gemcitabine medical

"formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies"

Gemcitabine is a chemotherapy drug that works by interfering with cancer cells’ ability to copy their DNA, which slows or stops tumor growth. Investors watch it because clinical trial results, regulatory approvals, patent status, or manufacturing and supply issues for a widely used cancer medicine can materially affect a drugmaker’s sales, partnerships, and stock value—think of it as a key product whose market performance can move a company.

docetaxel medical

"formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies"

A chemotherapy medicine that works by stopping cancer cells from dividing and growing, often used to treat several solid tumors. Investors care because its sales, patent status, approval or label changes, and trial results can significantly affect drugmakers’ revenue and stock value—similar to how a single bestselling product can move a company’s fortunes when customer demand or regulations change.

complete response medical

"showing a 92% complete response (CR) rate at any time point"

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

fda regulatory

"encouraging recent FDA discussions, which provide us with a well-defined"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

AI-generated analysis. Not financial advice.

Poster highlights 6-month follow-up data from the ongoing Phase 2 trial of NDV-01 in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety

Relmada plans to advance NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies in two indications in H1 2026

Company is focused on high-risk NMIBC and intermediate-risk NMIBC, representing about 80% of new NMIBC cases every year, or about 54,000 people in the United States

CORAL GABLES, Fla., Dec. 03, 2025 (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 indications, today announced that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26^th Annual Meeting (SUO 2025). The poster (#143) will be presented by Yair Lotan, MD, Chairman of Relmada’s Clinical Advisory Board, on Thursday, December 4^th at 2:30 PM MT in Phoenix, AZ.

Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics, noted, “We believe NDV-01 has the opportunity to transform the treatment of NMIBC by providing patients and physicians with a potential bladder-sparing, in-office, ready-to-use, safe, effective and durable, best-in-class therapy. We are on track to initiate the Phase 3 program in H1 2026, building on the encouraging, recently announced 9-month data, showing a 92% complete response (CR) rate at any time point, and encouraging recent FDA discussions, which provide us with a well-defined registrational strategy in two distinct indications in NMIBC with limited treatment options.”

The Society of Urologic Oncology 26^th Annual Meeting Information:

• Title: 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 6-month Complete Response Data
• Poster Number: #143
• Date and Time: Thursday, December 4^th at 2:30 PM MT
  
  

A copy of the poster will be available on the Events section of the Relmada website after the session. To review the an overview of the 9-month data and FDA discussions, click here.

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 a ready to use, convenient to administer in-office in less than 10 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 HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, follow 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 75-80% of all bladder cancer cases and is associated with high recurrence (50–80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

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 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

FAQ

What Phase 2 NDV-01 data will Relmada (RLMD) present at SUO 2025 on Dec 4, 2025?

Relmada will present 6-month follow-up safety and efficacy data for NDV-01 (Poster #143) on Dec 4, 2025 at 2:30 PM MT.

What is the 9-month complete response (CR) rate reported for NDV-01 by Relmada (RLMD)?

Relmada reported a 92% complete response (CR) rate at any time point in the 9-month data.

When does Relmada (RLMD) plan to start Phase 3 studies for NDV-01?

Relmada said it plans to advance NDV-01 into Phase 3 studies in H1 2026 for two NMIBC indications.

Which NMIBC patient groups is Relmada (RLMD) targeting with NDV-01 and how large is that population?

Relmada is focused on high‑risk and intermediate‑risk NMIBC, which it estimates represent about 80% of new NMIBC cases (~54,000 people in the US annually).

Where can investors access the NDV-01 poster after the SUO 2025 presentation?

A copy of the poster will be available in the Events section of Relmada's website after the session.