HC Wainwright initiated coverage on Relmada Therapeutics Inc. with a Buy rating and a price target of $12, driven by promising interim data from a Phase 2 trial of its bladder cancer candidate NDV-01. The rating reflects confidence in the clinical-stage biotechnology company's oncology pipeline, specifically the potential of NDV-01 to address unmet needs in non-muscle invasive bladder cancer (NMIBC). Relmada Therapeutics trades on the NASDAQ under the ticker symbol RLMD.

Phase 2 Data Highlights NDV-01 Potential

In March, Relmada released interim data from its ongoing Phase 2 trial of NDV-01 for treating NMIBC. The 12-month data showed a complete response rate of 76%, rising to 80% in the BCG-unresponsive patient population. At any time during the trial, the complete response rate reached 95% in high-risk bladder cancer patients and 94% in the BCG-unresponsive population.

Patent Protection and Analyst Perspective

In April 2026, Relmada filed a provisional patent application with the USPTO covering NDV-01 formulations and treatment methods. The firm expects any resulting patents to provide protection through April 2047. Analyst Andres Maldonado characterized NDV-01 as a next-generation delivery platform for a validated intravesical chemotherapy backbone rather than a wholly novel therapeutic modality. He noted that while the current standard, Gem/Doce, has seen adoption amid BCG shortages, its administration is cumbersome. NDV-01 aims to differentiate itself through durable recurrence control, clean safety, simple administration, and lower treatment burden.

Market Performance

Growing recognition of NDV-01's opportunity has driven a significant re-rating in RLMD shares over the past year. The stock has risen 800% compared to a 12% gain for the XBI index. At the time of publication on Thursday, Relmada Therapeutics shares were down 0.98% at $6.53.

Relmada Therapeutics, Inc. has appointed Michael Quirk, PhD, as Senior Advisor for its sepranolone program to advance the development of the GABA-A receptor modulator targeting Prader-Willi Syndrome and other central nervous system (CNS) indications. The appointment, effective June 11, 2026, leverages Quirk's extensive background in neuroscience drug discovery and translational science to bolster Relmada's CNS pipeline.

Quirk brings more than 20 years of biopharmaceutical industry experience, most recently serving as Chief Scientific Officer and interim Head of R&D at Sage Therapeutics. During his tenure at Sage, he contributed to the development of the first medicines approved for the treatment of Postpartum Depression and focused on brain health conditions at the intersection of neuroscience and women's health. Prior to joining Sage in 2014, he was a Director within the Neuroscience Innovative Medicine group at AstraZeneca.

"We are very pleased to welcome Mike to the Relmada team. His distinguished career in CNS drug discovery and development, including his leadership of research and scientific strategy at Sage Therapeutics, gives him a unique and highly relevant perspective on neuroactive steroid biology that we believe will be invaluable to the sepranolone program," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics.

Sepranolone Program Overview

Sepranolone is a synthetic isoallopregnanolone designed to selectively modulate GABA-A receptors by antagonizing allopregnanolone (ALLO) without broadly disrupting GABAergic signaling. The compound targets disorders linked to excess GABAergic activity, including Prader-Willi syndrome, Tourette syndrome, and obsessive-compulsive disorder (OCD). Clinical trials to date have treated more than 335 patients with sepranolone, demonstrating an excellent safety profile.

"Sepranolone's mechanism of action – selectively antagonizing the effects of allopregnanolone at GABA-A receptors without broadly disrupting GABAergic signaling – represents a precise and elegant approach to modulating neural circuits that are dysregulated in compulsivity-related disorders like Prader-Willi syndrome," said Dr. Quirk. "I believe sepranolone has the potential to be a genuinely differentiated medicine for patients who currently have very limited options."

About Prader-Willi Syndrome

Prader-Willi Syndrome (PWS) is a rare genetic disorder caused by chromosomal deletions on chromosome 15, resulting in neurodevelopmental and behavioral complications. The global prevalence of PWS is estimated to be between 350,000 and 400,000 patients. Current treatment options primarily address symptoms rather than modifying the underlying neurobehavioral pathology.

Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and CNS conditions. Its lead candidates, NDV-01 and sepranolone, are currently advancing through mid-stage clinical development.