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RLMD Relmada

Relmada Therapeutics Inc is a clinical-stage, publicly traded biotechnology company focused on the development of NDV-01 and sepranolone. NDV-01 is a novel, controlled-release intravesical formulation of gemcitabine and docetaxel. NDV-01 is currently in a Phase 2 clinical trial in Isreal to assess its safety and effica…

Assets on file: NDV-01

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Catalyst calendar

Dated catalysts for RLMD, including recently decided ones.

January 2027

Jan 2027

Jan 31, 2027

in 92 days

RLMDRelmada

NDV-01: Phase 2 trial NCT05644041 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

June 2027

Jun 2027

Jun 30, 2027

in 242 days

RLMDRelmada

NDV-01: Phase 3 trial NCT07342517 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

November 2027

Nov 2027

~ Nov 2027

RLMDRelmada

NDV-01: Phase 2 trial NCT06663137 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

September 2029

Sep 2029

Sep 1, 2029

in 1036 days

RLMDRelmada

NDV-01: Phase 3 trial NCT07313891 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

December 2029

Dec 2029

~ Dec 2029

RLMDRelmada

NDV-01: Phase 3 trial NCT07464145 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

January 2033

Jan 2033

Jan 1, 2033

in 2254 days

RLMDRelmada

NDV-01: Phase 2 trial NCT07322263 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Recent first-hand events

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Decision-gradeMaterialNotableMinor

Oct 26, 2026

03:25 PM

RLMDRelmada

NDV-01 · NCT05644041 registry update

primary_completion: 2027-01-31 → 2026-10-19; completion: 2027-01-31 → 2027-10-19

Trial registry changeClinicalTrials.gov

Nov 13, 2025

09:58 PM

RLMDRelmada

Relmada secures FDA alignment on two Phase 3 paths for NDV-01 in NMIBC

FDA Type B meeting confirmed two independent registrational paths: a single-arm study in high-risk BCG-unresponsive NMIBC and a randomized adjuvant study in intermediate-risk NMIBC. No additional non-clinical studies are required for a 505(b)(2) NDA. Phase 3 trials are expected to start in H1 2026.

Advisory committee scheduledSEC 8-K Open record