On March 9, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported 12-month interim data from its ongoing Phase 2 trial evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).

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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.

(Press release, Relmada Therapeutics, MAR 9, 2026, View Source [SID1234663371])