Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

Rhea-AI Summary

Relmada Therapeutics (Nasdaq: RLMD) announced FDA written feedback supporting its registrational development pathway for NDV-01 in two separate non-muscle invasive bladder cancer (NMIBC) indications.

The FDA indicated a single-arm, open-label registrational trial is appropriate for 2nd-line refractory, high-grade BCG-unresponsive NMIBC with carcinoma in situ (CIS). The agency also provided supportive written feedback for a single randomized-to-observation registrational trial in intermediate-risk NMIBC in the adjuvant setting. Relmada expects to initiate both Phase 3 registrational trials in 1H 2026.

Positive

• FDA provided written alignment on registrational pathway for NDV-01
• Single-arm, open-label registrational trial accepted for high-grade BCG-unresponsive NMIBC with CIS
• Supportive FDA feedback for randomized-to-observation registrational trial in intermediate-risk NMIBC
• Company expects to initiate both Phase 3 registrational trials in 1H 2026

Negative

• None.

News Market Reaction

-4.64%

2 alerts

-4.64% News Effect

+10.2% Peak Tracked

-$15M Valuation Impact

$316M Market Cap

0.0x Rel. Volume

On the day this news was published, RLMD declined 4.64%, reflecting a moderate negative market reaction. Argus tracked a peak move of +10.2% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $15M from the company's valuation, bringing the market cap to $316M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Registrational trials: 2 trials Line of therapy: 2nd-line Phase: Phase 3 +3 more

6 metrics

Registrational trials 2 trials NDV-01 studies for two NMIBC indications

Line of therapy 2nd-line Refractory high-grade BCG-unresponsive NMIBC with CIS

Phase Phase 3 Program expected to initiate for NDV-01

Start timing 1H 2026 Expected initiation of both registrational NDV-01 trials

Meeting type Type B pre-IND FDA written response guiding NDV-01 registrational design

Application path NDA Feedback supports a potential NDA submission for NDV-01

Market Reality Check

Price: $3.74 Vol: Volume 278,883 is about o...

low vol

$3.74 Last Close

Volume Volume 278,883 is about one-third of the 854,312 20-day average, indicating muted trading interest pre-release. low

Technical Price at $4.31 is trading above the $1.67 200-day moving average, reflecting a rebound from prior lows.

Peers on Argus

RLMD fell 2.71% while close peers showed mixed moves: declines in VTVT (-14.15%)...

RLMD fell 2.71% while close peers showed mixed moves: declines in VTVT (-14.15%), SER (-2.68%), ATNM (-2.8%) contrasted with gains in FGEN (+5.2%) and VERU (+1.7%). This pattern points to stock-specific factors rather than a uniform biotech-sector 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%	Phase 2 NDV-01 data and Phase 3 timing for two NMIBC indications.
Nov 13	Earnings and pipeline	Positive	-0.8%	Q3 results, NDV-01 data, FDA alignment, and cash runway into 2028.
Nov 07	Earnings scheduling	Neutral	+1.5%	Announcement of Q3 2025 earnings call and webcast logistics.
Nov 04	Equity offering	Positive	+25.9%	Pricing of $100M offering of common stock and pre-funded warrants.
Nov 04	Regulatory feedback	Positive	+25.9%	FDA support for two NDV-01 registrational Phase 3 pathways in NMIBC.

Pattern Detected

Recent NDV-01 and financing news skewed positive with mostly aligned price gains, but at least one positive clinical/financial update saw a modest negative reaction.

Recent Company History

Over the last few months, Relmada has steadily advanced NDV-01 and strengthened its balance sheet. On Nov 4, 2025, FDA feedback confirmed two potential registrational Phase 3 paths for NDV-01, coinciding with a large positive price move. A same-day $100M underwritten offering also saw a strong gain. The Q3 2025 10‑Q highlighted narrowed losses and FDA alignment on Phase 3 timing. A Dec 3, 2025 update emphasized favorable Phase 2 data and plans for Phase 3 in H1 2026. Today’s detailed design confirmation fits this ongoing regulatory progression.

Market Pulse Summary

This announcement confirms FDA alignment on two registrational Phase 3 designs for NDV-01, targeting...

Analysis

This announcement confirms FDA alignment on two registrational Phase 3 designs for NDV-01, targeting high‑grade BCG‑unresponsive NMIBC with CIS and intermediate‑risk NMIBC, with both trials expected to start in 1H 2026. It builds directly on prior FDA feedback in Nov 2025 and favorable Phase 2 data updates in Dec 2025. Investors may track execution toward trial initiation, future data disclosures, and capital allocation decisions alongside ongoing insider share purchases and equity-based compensation grants.

Key Terms

non-muscle invasive bladder cancer, NMIBC, carcinoma in situ, CIS, +4 more

8 terms

non-muscle invasive bladder cancer medical

"non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)"

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.

NMIBC medical

"non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)"

A common form of bladder cancer that stays confined to the bladder’s inner lining or the layer just below it and has not grown into the deeper muscle wall. It matters to investors because it often requires repeated procedures, ongoing surveillance and long-term treatments, creating a sizable and stable market for diagnostics, drugs and medical devices; think of it like a surface-level problem that needs frequent check-ups and follow-up care rather than a one-time fix.

carcinoma in situ medical

"with carcinoma in situ (CIS) -- one of the highest-risk"

Carcinoma in situ is an early-stage abnormal growth where cells look cancerous but remain confined to the tissue surface and have not invaded deeper layers or spread to other parts of the body; think of it like graffiti on a wall that hasn’t cracked the plaster beneath. For investors, it matters because treatments, regulatory pathways, clinical trial outcomes and long-term costs differ greatly between contained lesions and invasive cancer, influencing market value, approval odds and liability for healthcare companies.

CIS medical

"with carcinoma in situ (CIS) -- one of the highest-risk"

Cis is a descriptor from chemistry meaning two parts of a molecule sit on the same side of a bond or ring, like two passengers sitting on the same side of a seesaw. That arrangement can change a drug’s shape, how it behaves in the body, and whether regulators approve it or competitors can patent it. Investors watch “cis” versus “trans” forms because those small structural differences can affect safety, effectiveness, manufacturing and commercial value.

BCG-unresponsive medical

"high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)"

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.

adjuvant setting medical

"intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies"

Adjuvant setting describes giving a medical treatment after a main therapy (most often after surgery) to lower the chance that a disease will return; think of it as applying a follow-up guard to catch any remaining cells the primary treatment missed. For investors this matters because success in the adjuvant setting can greatly expand the number of patients eligible for a drug, extend treatment durations, and change regulatory and commercial value compared with use only in later-stage or salvage care.

pre-IND regulatory

"In its written response to Relmada’s Type B pre-IND submission, the FDA indicated"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

NDA submission regulatory

"path toward a potential NDA submission for NDV-01 as a bladder-sparing"

An NDA submission is the formal application a drug developer files with a medicines regulator seeking permission to market a new prescription drug. Think of it as the final product pitch that compiles all clinical trial results, safety data and manufacturing details so the regulator can decide whether the drug can be sold. For investors, an NDA submission is a major milestone because acceptance or approval can unlock sales and revenue, while delays or rejections create uncertainty and financial risk.

AI-generated analysis. Not financial advice.

FDA written feedback supports:

- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS

- a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting

Phase 3 program expected to initiate in 1H 2026

CORAL GABLES, Fla., Jan. 12, 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 that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) -- one of the highest-risk and most treatment-resistant NMIBC populations -- and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies.

In its written response to Relmada’s Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need.

The FDA also provided separate, supportive written feedback on the Company’s planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design.

Relmada continues to anticipate initiating both registrational trials in the first half of 2026.

“We are very pleased with the FDA’s alignment on the registrational design for NDV-01 in high-grade BCG-unresponsive NMIBC,” said Raj S. Pruthi, MD, Chief Medical Officer – Oncology at Relmada Therapeutics. “A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives. This study represents the fastest path to approval for NDV-01.”

Dr. Pruthi continued, “We are also encouraged by the FDA’s feedback on our intermediate-risk registration plans, where we believe NDV-01 could potentially provide meaningful clinical benefit to patients where no approved treatments currently exist.”

About the Planned High-Grade Registrational Study

The planned pivotal Phase 3 study in 2nd-line, refractory, high-grade BCG-unresponsive NMIBC with carcinoma in situ (CIS) will be an open-label, single-arm trial evaluating:

• Primary endpoint: Complete response (CR) rate at any time
• Key secondary endpoint: Duration of response (DOR)
• Assessments: Cystoscopy, cytology, and biopsy per protocol
  
  

The design reflects FDA’s written guidance on the study population, endpoint selection, and evaluation methodology and is consistent with prior FDA precedents for single-arm registrational trials in NMIBC.

About the Planned Intermediate-Risk Registrational Study

The planned pivotal Phase 3 study in intermediate-risk NMIBC in the adjuvant setting will be an open label randomized-to-observation study:

• Primary endpoint: Disease Free Survival (DFS)
• Key secondary endpoint: Duration of response (DOR)
• Assessments: Cystoscopy, cytology, and biopsy per protocol
  
  

The design reflects FDA’s written guidance on the study population, endpoint selection, and evaluation methodology.

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 ten 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 five minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

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 did Relmada (RLMD) announce about NDV-01 on January 12, 2026?

Relmada announced FDA written feedback supporting registrational trial designs for NDV-01 in two NMIBC indications and plans to start Phase 3 trials in 1H 2026.

What registrational trial design did the FDA support for NDV-01 in high-grade BCG-unresponsive NMIBC (RLMD)?

The FDA indicated a single-arm, open-label registrational trial is an appropriate approach for the high-grade BCG-unresponsive NMIBC with CIS population.

What trial design did the FDA support for NDV-01 in intermediate-risk NMIBC for RLMD?

The FDA provided supportive written feedback for a single randomized-to-observation registrational study in the adjuvant intermediate-risk NMIBC setting.

When does Relmada expect to initiate the NDV-01 Phase 3 registrational program (RLMD)?

Relmada continues to anticipate initiating both registrational trials in the first half of 2026.

What unmet need does NDV-01 target according to Relmada (RLMD)?

NDV-01 targets 2nd-line refractory, high-grade BCG-unresponsive NMIBC with CIS and intermediate-risk NMIBC in the adjuvant setting, where approved therapies are limited or do not exist.