공시 • Apr 09
Relmada Therapeutics, Inc., Annual General Meeting, May 27, 2026 Relmada Therapeutics, Inc., Annual General Meeting, May 27, 2026. 공시 • Mar 13
Relmada Therapeutics, Inc. announced that it has received $159.999996 million in funding from a group of investors On March 12, 2026, Relmada Therapeutics, Inc. closed the transaction. The transaction has been oversubscribed, with participation from leading healthcare investors. 공시 • Mar 12
Relmada Therapeutics, Inc. to Report Q4, 2025 Results on Mar 19, 2026 Relmada Therapeutics, Inc. announced that they will report Q4, 2025 results on Mar 19, 2026 공시 • Mar 10
Relmada Therapeutics Reports 12-Month Phase 2 Interim Data For NDV-01 In Non-Muscle Invasive Bladder Cancer Relmada Therapeutics, Inc. 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. 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). 공시 • Mar 09
Relmada Therapeutics, Inc. announced that it expects to receive $159.999996 million in funding from a group of investors Relmada Therapeutics, Inc. entered into a securities purchase agreement for a private investment in public equity financing by issuing 29,474,569 shares at a price of $4.75 per share for gross proceeds of $ 140,004,202.75 and pre-funded warrant of 4,210,527 at a price of $4.749 per pre-funded warrant for gross proceeds of $ 19,995,792.723 and total aggregate of $ 159,999,995.473 on March 9, 2026. Each warrant is converted into common shares and Each warrant entitles the holder thereof to acquire one additional common share at an exercise price of $0.001 per share. The offering involves investor participation from Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, RA Capital Management, Balyasny Asset Management, OrbiMed, Spruce Street Capital, Squadron Capital Management, Columbia Threadneedle Investments, Adage Capital Management, Marshall Wace, Braidwell LP, Great Point Partners, LLC and Eventide Asset Management. The PIPE financing is expected to close on or about March 11, 2026, subject to satisfaction of customary closing conditions. 공시 • Jan 13
Relmada Therapeutics, Inc. Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications Relmada Therapeutics, Inc. 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. 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. The planned pivotal Phase 3 trial 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 responses (DOR); Assessment: Cystoscopy, Cystoscopy, cytological, and biopsy per protocol; The design reflects FDA's writing guidance on the study population, end-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/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, estimating the Company's cash runway. 
