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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