Relmada Therapeutics Inc Stock Price, News & Analysis

Relmada Therapeutics (NASDAQ:RLMD), a clinical-stage biotechnology company focused on oncology and central nervous system therapies, will host a conference call and webcast on Thursday, August 7, 2025, at 4:30 PM ET to discuss Q2 2025 financial results and business updates.

The conference call will be accessible via US dial-in (1-877-407-0792) and International dial-in (1-201-689-8263) with conference code 13754263. A webcast replay will be available in the Investors section of Relmada's website.

Relmada Therapeutics (NASDAQ:RLMD) has appointed renowned urologic oncologist Dr. Yair Lotan as Chair of its Clinical Advisory Board (CAB). Dr. Lotan, with over 20 years of experience in bladder cancer care and clinical development, will support the advancement of NDV-01, the company's treatment for non-muscle invasive bladder cancer (NMIBC).

The appointment comes as Relmada prepares to initiate a Phase 3 trial for NDV-01 in H1 2026, following positive Phase 2 data presented at AUA 2025. NDV-01's ready-to-use sustained release formulation aims to improve upon the current gemcitabine/docetaxel combination treatment by offering easier administration outside hospital settings.

Relmada Therapeutics (NASDAQ: RLMD) has appointed Dr. Raj S. Pruthi as Chief Medical Officer-Urology to lead the development of NDV-01, their lead program for non-muscle invasive bladder cancer (NMIBC). Dr. Pruthi brings over 25 years of experience in urologic oncology and clinical trials, having previously served as CMO at enGene Holdings and Global Medical Affairs leader at Johnson & Johnson. The appointment follows positive Phase 2 data presented at AUA 2025, showing promising response rates for NDV-01's gemcitabine/docetaxel sustained release formulation. The company plans to initiate Phase 3 trials for NDV-01 in H1 2026. Dr. Pruthi's expertise in bladder cancer treatments and clinical development will be crucial for advancing NDV-01, which aims to provide a simpler, more patient-friendly treatment option compared to current complex therapies.

Relmada Therapeutics (RLMD) reported Q1 2025 financial results and provided pipeline updates. The company highlighted positive Phase 2 proof-of-concept data for NDV-01, showing a 90% overall response rate in non-muscle invasive bladder cancer patients. Key financial metrics include: net loss of $17.5 million ($0.58/share), R&D expenses of $11.9 million, and cash position of $27.1 million. NDV-01, a sustained-release intravesical formulation, demonstrated 89% high-grade recurrence-free survival in papillary disease and 100% complete response in carcinoma in situ. The company plans to initiate a Phase 3 trial for NDV-01 and a Phase 2 study for sepranolone in Prader-Willi syndrome in H1 2026.

Relmada Therapeutics (NASDAQ: RLMD), a clinical-stage biotechnology company, has scheduled its first quarter 2025 financial results conference call and webcast for Monday, May 12, 2025, at 4:30 PM ET. The event will cover financial performance for Q1 ending March 31, 2025, and provide updates on recent business developments.

Investors can access the conference via US dial-in (1-877-407-0792) or International dial-in (1-201-689-8263) using conference code 13753596. A webcast replay will be available in the Investors section of Relmada's website.

Relmada Therapeutics announced positive initial Phase 2 data for NDV-01, their treatment for non-muscle invasive bladder cancer (NMIBC), at AUA2025. The study showed remarkable efficacy with 90% of patients achieving high-grade disease-free status.

Key results include:

• 85% overall response rate at 3 months (17/20 patients)
• 83.3% high-grade recurrence-free survival in papillary disease
• 100% complete response in CIS patients
• 100% disease-free status at 6 months for evaluable patients

The treatment showed strong effectiveness across all patient groups, including both BCG-naïve and BCG-unresponsive patients. NDV-01's safety profile was favorable, with only mild, temporary side effects reported. The treatment can be administered in under 10 minutes, potentially offering a significant advancement in outpatient bladder cancer care.

The ongoing study has enrolled 26 patients total, with 20 reaching the 3-month assessment mark. The company aims to position NDV-01 as a leading therapy for NMIBC treatment.

Relmada Therapeutics (NASDAQ: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29th, 2025. The company will present data on NDV-01, their investigational treatment, during the Clinical Trials in Progress Session.

The abstract, focusing on a prospective open-label study, will evaluate the safety and efficacy of intravesical sustained release Gemcitabine Docetaxel combination (NDV-01) in High Risk NMIBC. The presentation is scheduled for April 28, 2025, from 10:04 AM PT to 10:12 AM PT in Hall C, The Square, Learning Lab.

Relmada Therapeutics (Nasdaq: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29th, 2025. The company will present data on NDV-01, a combination therapy of intravesical sustained release Gemcitabine and Docetaxel.

The presentation, categorized as Paradigm-Shifting, will focus on a prospective open-label study evaluating NDV-01's safety and efficacy in High Risk NMIBC. The abstract presentation is scheduled for April 28, 2025, at 10:04 AM PT.

Relmada Therapeutics (NASDAQ: RLMD) has announced its upcoming presentation at the American Urology Association (AUA2025) conference in Las Vegas, scheduled for April 26-29, 2025. The company will present data on NDV-01, a combination therapy of intravesical sustained release Gemcitabine and Docetaxel.

The presentation, categorized as Paradigm-Shifting, will focus on a prospective open-label study evaluating the safety and efficacy of NDV-01 in High Risk NMIBC. The abstract will be presented on Monday, April 28, 2025, at 10:04 AM PT.