Relmada Therapeutics Reports 12-Month Phase 2 Interim Data for NDV-01 in Non-Muscle Invasive Bladder Cancer

Rhea-AI Summary

Relmada Therapeutics (Nasdaq: RLMD) reported 12-month Phase 2 interim data for NDV-01 in high-risk non-muscle invasive bladder cancer. The study showed a 12-month complete response (CR) rate of 76% overall and 80% in BCG-unresponsive patients, with 95% and 94% CR rates at any time, respectively. No patients progressed to muscle-invasive disease or required radical cystectomy. No ≥ Grade 3 treatment-related adverse events or treatment discontinuations were reported. Relmada plans IND clearance and initiation of the Phase 3 RESCUE program in mid-2026, with initial Phase 3 3-month readouts expected by year-end 2026.

Positive

• 12-month CR 76% in overall high-risk NMIBC
• 12-month CR 80% in BCG-unresponsive subpopulation
• 95% anytime CR in overall population; 94% anytime CR in BCG-UR
• No progression to muscle-invasive disease and no radical cystectomies
• No ≥ Grade 3 treatment-related adverse events reported
• Phase 3 RESCUE program and IND clearance planned mid-2026

Negative

• CR fell from 95% anytime to 76% at 12 months (19 percentage-point drop)
• Small treated cohort: N=48 overall; N=20 in BCG-unresponsive subgroup
• 63% of dosed patients experienced a treatment-related adverse event

News Market Reaction – RLMD

+61.12%

41 alerts

+61.12% News Effect

+77.2% Peak in 20 min

+$208M Valuation Impact

$549M Market Cap

1.4x Rel. Volume

On the day this news was published, RLMD gained 61.12%, reflecting a significant positive market reaction. Argus tracked a peak move of +77.2% during that session. Our momentum scanner triggered 41 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $208M to the company's valuation, bringing the market cap to $549M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

CR rate 12 months (overall): 76% CR rate anytime (overall): 95% (36/38) CR rate 12 months (BCG-UR): 80% (8/10) +5 more

8 metrics

CR rate 12 months (overall) 76% Phase 2 NDV-01 trial in high-risk NMIBC, 12-month complete response rate

CR rate anytime (overall) 95% (36/38) Phase 2 NDV-01 trial, best complete response at any time in overall population

CR rate 12 months (BCG-UR) 80% (8/10) BCG-unresponsive NDV-01 Phase 2 subpopulation, 12-month complete response rate

CR rate anytime (BCG-UR) 94% (16/17) BCG-unresponsive NDV-01 Phase 2 subpopulation, best complete response at any time

Grade ≥3 TRAEs 0 patients No treatment-related adverse events of Grade 3 or higher reported

Patients dosed (overall) 48 patients Total Phase 2 NDV-01 trial population receiving ≥1 dose

Patients dosed (BCG-UR) 20 patients BCG-unresponsive subpopulation receiving NDV-01 in Phase 2 trial

Patients with TRAEs 63% (30/48) Proportion of dosed patients experiencing any treatment-related adverse event

Market Reality Check

Price: $6.32 Vol: Volume 448,211 vs 20-day ...

normal vol

$6.32 Last Close

Volume Volume 448,211 vs 20-day average 580,385 (relative volume 0.77x) indicates no pre-news accumulation signal. normal

Technical Shares at $4.45, trading above 200-day MA of $2.38 and about 13.09% below the 52-week high.

Peers on Argus

Biotech peers show mixed moves: FGEN +5.2%, ATNM +0.84%, while VTVT -5.07%, SER ...

1 Down

Biotech peers show mixed moves: FGEN +5.2%, ATNM +0.84%, while VTVT -5.07%, SER -1.29%, VERU -1.2%. With RLMD’s modest 0.45% gain, the pattern points to stock-specific drivers rather than a coordinated sector rotation.

Previous Clinical trial Reports

5 past events · Latest: Dec 03 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Phase 2 data update	Positive	+0.5%	Presented favorable NDV-01 Phase 2 safety and high CR rates at SUO meeting.
Apr 28	Initial Phase 2 data	Positive	-44.6%	Reported strong initial NDV-01 efficacy across NMIBC groups with mild side effects.
Mar 25	Asset licensing	Positive	+6.1%	Licensed NDV-01 bladder cancer candidate with sustained delivery and favorable safety.
Dec 09	Program discontinuation	Negative	+5.1%	Ended two REL-1017 Phase 3 MDD studies and launched strategic alternatives review.
Dec 04	Trial futility update	Negative	-77.3%	DMC said REL-1017 Phase 3 trial unlikely to meet primary endpoint despite no new safety issues.

Pattern Detected

Clinical and pipeline news often trigger sizable but directionally mixed moves, with several large divergences from the apparent sentiment.

Recent Company History

Over the last year, Relmada shifted its focus toward oncology and NDV-01. The company licensed NDV-01 in March 2025 and quickly produced positive Phase 2 data, including high disease‑free and complete response rates. Subsequent updates in April 2025 and December 2025 highlighted sustained efficacy and favorable safety, while outlining dual Phase 3 paths in NMIBC. In parallel, Relmada discontinued late‑stage REL‑1017 depression trials in December 2024, exploring strategic alternatives. Today’s 12‑month data extend the NDV-01 efficacy and safety story that underpinned the planned Phase 3 RESCUE program.

Historical Comparison

-22.0% avg move · Across 5 clinical-trial headlines, average 24h move was -22.03%, showing historically volatile react...

clinical trial

-22.0%

Average Historical Move clinical trial

Across 5 clinical-trial headlines, average 24h move was -22.03%, showing historically volatile reactions to trial news.

Clinical-trial news traces NDV-01’s path from licensing in March 2025 to initial positive Phase 2 data in April 2025, and then to detailed 6‑month follow-up in December 2025. Those updates, together with FDA feedback, set up dual Phase 3 pathways in NMIBC. The current 12‑month interim results extend this sequence by adding longer-term durability and safety data within the same Phase 2 program.

Market Pulse Summary

The stock surged +61.1% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +61.1% in the session following this news. A strong positive reaction aligns with the clearly favorable NDV-01 data, including a 76% 12‑month complete response rate and no Grade ≥3 treatment‑related events. Historically, clinical‑trial headlines for this name averaged -22.03% 24‑hour moves, showing that sentiment has been volatile. Investors may weigh these results against prior large drawdowns on trial news and the potential overhang from future financings or profit‑taking after sharp gains.

Key Terms

non-muscle invasive bladder cancer, complete response, BCG-unresponsive, Kaplan-Meier analysis, +4 more

8 terms

non-muscle invasive bladder cancer medical

"ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer"

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.

complete response medical

"Durable 76% complete response (CR) rate at 12 months with 95% CR rate"

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.

BCG-unresponsive medical

"12-month CR rate of 80% was achieved in the BCG-unresponsive population"

BCG-unresponsive describes a situation in which a patient’s bladder cancer does not shrink or returns despite receiving an adequate course of BCG, a common vaccine-based intravesical treatment used to stimulate the immune system in the bladder. For investors this matters because it defines a group of patients who need alternative therapies or procedures, shaping clinical trial eligibility, regulatory pathways, and the potential market for new drugs; think of it like weeds that resist the usual weed killer and require a different product.

Kaplan-Meier analysis medical

"12-month KM analysis | 83% N=48 patients dosed in overall population; KM: Kaplan-Meier analysis"

Kaplan-Meier analysis is a statistical method that estimates how long it takes for an event of interest to occur, such as patient survival or time until disease progression, and displays that information as a curve over time. For investors, it matters because these curves quantify a treatment’s real-world durability and risk profile—clear separation or improvement can drive regulatory decisions, uptake, and a company’s valuation, much like tracking how many light bulbs remain working over months.

treatment-related adverse event medical

"no ">= Grade 3 treatment-related adverse events and no treatment-related discontinuations"

An unwanted medical effect experienced by a patient that clinicians or regulators judge to be caused by a drug, device, or therapy given during a clinical program. Investors care because these safety signals can delay or halt approvals, require extra studies, raise development costs, trigger recalls or legal exposure, and change a product’s market prospects — think of it as a warning light on a car that directly links a new repair to a new problem.

radical cystectomy medical

"no patients requiring radical cystectomy"

Radical cystectomy is a major surgical procedure that removes the urinary bladder and nearby tissues to treat severe bladder disease, often followed by creating a new way for urine to leave the body. For investors, it signals demand for hospitals, surgical devices, reconstruction products and post‑operative care services, and can affect the market prospects of medical device makers, drug developers and health-care providers the way removing a core part of a machine changes the need for replacement parts and repairs.

disease free survival (DFS) medical

"Primary endpoint: Disease Free Survival (DFS)"

Disease free survival (DFS) measures the length of time after a medical treatment during which a patient shows no signs of the disease returning; it counts until either the disease comes back or the patient dies. Investors watch DFS because longer DFS suggests a treatment is effective at preventing relapse, which can predict regulatory approval, market uptake, and future revenue potential—think of it as a stopwatch showing how long a cure holds.

progression free survival (PFS) medical

"Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS)"

Progression free survival (PFS) is the amount of time after a treatment starts during which a patient’s disease does not get worse. Investors watch PFS because it’s a commonly reported measure in clinical trials that can indicate a drug’s effectiveness earlier than overall survival, much like measuring how long a dam holds before leaks reappear; stronger PFS results can speed regulatory decisions and affect a drug’s commercial prospects.

AI-generated analysis. Not financial advice.

• Durable 76% complete response (CR) rate at 12 months with 95% CR rate at any time in high-risk NMIBC
• BCG-unresponsive patients achieved an 80% CR rate at 12 months and 94% CR rate at any time
• Tolerability profile remains favorable – no ≥ Grade 3 treatment-related adverse events and no treatment-related discontinuations
• Data reinforces advancement of NDV-01 into Phase 3 RESCUE registrational program in second line (2L) BCG-unresponsive and adjuvant intermediate-risk NMIBC in mid-2026

CORAL GABLES, Fla., March 09, 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 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

The Phase 2 trial of NDV-01 demonstrated a 12-month complete response (CR) rate of 76% with a favorable safety profile. Notably, a 12-month CR rate of 80% was achieved in the BCG-unresponsive population, one of the most difficult-to-treat segments of NMIBC. Taken together, these findings support the potential best-in-class profile of NDV-01 and support advancement into the Phase 3 RESCUE registrational program evaluating NDV-01 in both 2L BCG-unresponsive and adjuvant intermediate-risk NMIBC.

“These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile,” said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. “Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026.”

“I am highly encouraged by NDV-01’s high response rates, 12-month durability and favorable tolerability profile. Building on the clinical community’s familiarity with conventional Gem/Doce, these Phase 2 results provide robust validation of NDV-01’s novel sustained release formulation. In addition, NDV-01’s less than 5-minute administration simplifies dosing for clinical staff, supporting broad adoption in community urology practices where ~80% of NMIBC patients are treated – and potentially offering a significantly more streamlined user experience than currently approved therapies,” said Max Kates, MD, Director of Urologic Oncology at Johns Hopkins and Relmada Clinical Advisor.

Highlights of the 12-month follow-up data from the Ongoing Phase 2 study of NDV-01:

Clinical Results (Response Data)
Complete Response
Anytime	95% (36/38)
3 month	87% (33/38)
6 month	86% (25/29)
9 month	85% (22/26)
12 month	76% (19/25)
12-month KM analysis	83%
N=48 patients dosed in overall population; KM: Kaplan-Meier analysis

Efficacy in BCG-Unresponsive Subpopulation**:

Clinical Results (Response Data)
Complete Response
Anytime	94% (16/17)
3 month	82% (14/17)
6 month	86% (12/14)
9 month	91% (10/11)
12 month	80% (8/10)
12-month KM analysis	84%
N=20 patients dosed in BCG-UR subpopulation; ** BCG-UR defined by FDA definition; BCG-UR: Bacillus Calmette-Guérin (BCG) – Unresponsive; KM: Kaplan-Meier analysis

• No patient had progression to muscle-invasive disease
• No patient underwent a radical cystectomy
• No patients had a ≥ Grade 3 treatment related adverse event (TRAE)
• No patients discontinued treatment due to AEs
• Of the 48 patients who received ≥ 1 dose, 30 (63%) experienced a treatment-related adverse event (AE).
• Among treatment-related AEs,
  • 54% were transient uncomfortable urination (dysuria, <24 hours, Grade 1)
  • 8% had an asymptomatic positive urine culture
  • 8% had hematuria
    

Phase 3 RESCUE Registrational Pathways:

Registrational Pathway 1 – An open label randomized controlled trial in intermediate-risk NMIBC of adjuvant therapy following TURBT (NDV-01 vs. observation). There are no approved treatments for adjuvant intermediate risk NMIBC, which we estimate affects ~75,000 patients/year in the US.

• Primary endpoint: Disease Free Survival (DFS)
• Key secondary endpoints: High-grade recurrence free survival (HG-RFS), progression free survival (PFS), quality of life (QOL) metrics

Registration Pathway 2 – A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ (CIS) patients who are currently refractory to approved or developmental therapies. Patients with BCG-unresponsive NMIBC with CIS who fail first line (1L) therapies, which we estimate to affect ~5,000 patients/year in the US, have few, if any, effective treatment alternatives to radical cystectomy.

• Primary endpoint: Complete response (CR) rate at any time
• Key secondary endpoint: Duration of response (DOR), progression free survival (PFS), recurrence free survival (RFS) amongst responders

Expected Upcoming NDV-01 Milestones:

• NDV-01 United States IND clearance – Mid-2026
• Phase 3 RESCUE Program Initiation – Mid-2026
• Initial 3-month results from Phase 3 2L BCG-unresponsive study expected by YE 2026
  

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 approximately 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 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 75-80% 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. High-grade BCG-unresponsive disease represents one of the most difficult-to-treat NMIBC subtypes, with limited bladder-sparing options. Intermediate-risk NMIBC in the adjuvant setting has no currently approved therapies. 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 12-month efficacy did Relmada (RLMD) report for NDV-01 in NMIBC on March 9, 2026?

NDV-01 showed a 12-month complete response rate of 76% overall. According to the company, the BCG-unresponsive subgroup had an 80% 12-month CR and anytime CRs of 95% (overall) and 94% (BCG-UR).

How safe was NDV-01 in the Phase 2 NMIBC study reported by Relmada (RLMD)?

Safety appeared favorable with no ≥ Grade 3 treatment-related adverse events reported. According to the company, there were no treatment-related discontinuations and no patients progressed to muscle-invasive disease or required radical cystectomy.

When will Relmada (RLMD) start the Phase 3 RESCUE program for NDV-01?

Relmada expects to initiate the Phase 3 RESCUE registrational program in mid-2026. According to the company, IND clearance and program initiation are both targeted for mid-2026, with initial 3-month Phase 3 results expected by year-end 2026.

What are the primary endpoints for Relmada's (RLMD) planned Phase 3 NDV-01 trials?

For adjuvant intermediate-risk NMIBC the primary endpoint is disease-free survival (DFS); for 2L BCG-unresponsive CIS the primary endpoint is complete response rate at any time. According to the company, key secondaries include DOR, PFS, and RFS.

How large was the Phase 2 cohort and why does that matter for NDV-01's results?

The Phase 2 dataset included 48 dosed patients overall and 20 in the BCG-unresponsive subgroup. According to the company, the relatively small cohort size may limit statistical certainty and supports the rationale for a registrational Phase 3 program.