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Relmada Highlights NDV-01 Data, Funding in 2025 Results

Story Highlights
  • Relmada posted strong Phase 2 NDV-01 bladder cancer data and finalized 2025 results.
  • New financing and reduced R&D spending extend Relmada’s cash runway and fund NDV-01 Phase 3.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Relmada Highlights NDV-01 Data, Funding in 2025 Results

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The latest announcement is out from Relmada Therapeutics ( (RLMD) ).

Relmada Therapeutics reported audited fourth-quarter and full-year 2025 results on March 19, 2026, alongside a business update that underscored strong 12-month Phase 2 data for NDV-01 in high-risk NMIBC, showing a 95% complete response rate at any time and a 76% rate at 12 months, with no progression to muscle-invasive disease or radical cystectomies. Supported by FDA alignment on two Phase 3 RESCUE registrational pathways and a strengthened balance sheet, including $93 million in cash at year-end 2025 and an oversubscribed $160 million PIPE completed in March 2026, the company is transitioning from its prior REL-1017 focus to advance NDV-01 into Phase 3 in mid-2026, while reducing annual R&D spend, narrowing net loss to $57.4 million in 2025, and extending its cash runway to fund operations through 2029.

R&D expenses fell sharply in 2025 as Relmada wound down two Phase 3 REL-1017 trials and redirected resources to NDV-01 and sepranolone, while G&A costs declined for the full year on lower stock-based compensation despite higher personnel expenses. The company plans to initiate the U.S. IND and Phase 3 RESCUE program for NDV-01 and a Phase 2 study of sepranolone in Prader-Willi syndrome in mid-2026, with initial three-month Phase 3 data in second-line BCG-unresponsive NMIBC expected by year-end 2026, developments that could solidify its position in bladder cancer therapeutics and provide greater visibility for investors on its late-stage pipeline.

The most recent analyst rating on (RLMD) stock is a Buy with a $19.00 price target. To see the full list of analyst forecasts on Relmada Therapeutics stock, see the RLMD Stock Forecast page.

Spark’s Take on RLMD Stock

According to Spark, TipRanks’ AI Analyst, RLMD is a Neutral.

The score is held back primarily by weak financial performance (no revenue, ongoing large losses, and sustained cash burn with a shrinking equity base). Offsetting this, recent communications were notably positive with strong NDV-01 clinical results, FDA alignment, and a $100M raise extending runway into 2028, while technicals also show improving price momentum; valuation remains difficult to support given negative earnings and no dividend.

To see Spark’s full report on RLMD stock, click here.

More about Relmada Therapeutics

Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system disorders. Its lead oncology candidate, NDV-01, targets non-muscle invasive bladder cancer (NMIBC), including high-risk and BCG-unresponsive populations, positioning the company in a significant unmet-need segment of the urologic oncology market.

Average Trading Volume: 1,433,969

Technical Sentiment Signal: Hold

Current Market Cap: $458.3M

For a thorough assessment of RLMD stock, go to TipRanks’ Stock Analysis page.

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