On Thursday, HC Wainwright initiated coverage on Relmada Therapeutics Inc. (NASDAQ:RLMD) with a primary focus on bladder cancer treatment regimen.
The clinical-stage biotechnology company is focused on developing therapies for oncology and central nervous system conditions, with NDV-01 and sepranolone as lead candidates.
Phase 2 Data Highlight NDV-01’s Potential In NMIBC
In March, Relmada released promising interim data from its Phase 2 trial of NDV-01 for treating non-muscle invasive bladder cancer (NMIBC).
The 12-month interim data from the ongoing Phase 2 trial showed a complete response rate of 76%, with an impressive 80% in the BCG-unresponsive patient population.
The trial showed a complete response rate of 95% at any time in high-risk bladder cancer patients, and 94% at any time in the BCG-unresponsive patient population.
Patent Filing Could Extend Protection Through 2047
In April 2026, Relmada filed a provisional patent application with the USPTO covering NDV-01 formulations and treatment methods.
The filing could support a broader global patent strategy for NDV-01, with any resulting patents expected to protect through April 2047.
Analyst Andres Maldonado wrote, “In our view, NDV-01 is best understood as a next-generation delivery platform for a familiar and increasingly validated intravesical chemotherapy backbone rather than a wholly novel therapeutic modality.”
HC Wainwright initiated with a Buy rating and a price forecast of $12.
The distinction is important, the analyst noted, because Gem/Doce has already seen meaningful adoption in NMIBC, particularly amid ongoing BCG shortages.
However, its conventional aqueous administration remains cumbersome, requiring sequential instillation, longer dwell and chair time, pharmacy coordination, and multi-hour clinic visits.
Relmada Stock Outperforms XBI Over The Past Year
Growing recognition of this opportunity has helped drive a significant re-rating in RLMD shares over the past year, with the stock up 800% compared with a 12% gain for XBI.
The analyst further wrote that, “The field is moving toward a multi-agent bladder-sparing ecosystem, where therapies like NDV-01 can be differentiated by durable recurrence control, clean safety, simple administration, lower treatment burden, and broad community-urology compatibility.”
RLMD Stock Price Activity: Relmada Therapeutics shares were down 0.98% at $6.53 at the time of publication on Thursday, according to Benzinga Pro data.
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