RLMD Shares Jump 42% Over the Past Week: Key Information You Need

Relmada Therapeutics Sees Stock Surge Following Positive NDV-01 Trial Results

Relmada Therapeutics (RLMD) experienced a remarkable 42% increase in its share price over the past week, following the release of encouraging 12-month interim results from its ongoing phase II trial of NDV-01. This investigational therapy is being studied in patients with high-risk non-muscle invasive bladder cancer (NMIBC) and utilizes a sustained-release, intravesical combination of gemcitabine and docetaxel.

The interim analysis revealed that NDV-01 achieved a 76% complete response (CR) rate at the 12-month mark. The durability of response was notable, with CR rates of 87% at three months, 86% at six months, and 85% at nine months. Impressively, 95% of patients who could be evaluated experienced a complete response at some point during the year-long treatment period.

NDV-01 also demonstrated meaningful efficacy in patients whose disease did not respond to BCG therapy—a group with limited treatment options. In this challenging population, the 12-month CR rate reached 80%. Importantly, none of the participants progressed to muscle-invasive disease or required radical cystectomy during the study, supporting the continued advancement of NDV-01. Based on these promising findings, Relmada Therapeutics intends to move NDV-01 into the phase III RESCUE registration program, targeting both second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC indications.

Safety data from the phase II trial were also positive. Most treatment-related side effects were mild or moderate, and no patients discontinued therapy due to adverse events, suggesting NDV-01 is generally well tolerated.

Over the last six months, Relmada Therapeutics’ stock has soared by 278.4%, in stark contrast to a 6.4% decline in the broader medical drugs industry.

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Future Directions for NDV-01 in Bladder Cancer

Earlier this year, Relmada Therapeutics secured FDA guidance on two potential registration strategies for NDV-01, setting the stage for the phase III RESCUE program. The company aims to expand development into two NMIBC patient groups: those at intermediate risk following tumor removal, and individuals with BCG-unresponsive disease who have few remaining options. The strong phase II data reinforce NDV-01’s potential as a leading therapy and support its progression into late-stage trials for both groups.

• Adjuvant Therapy in Intermediate-Risk NMIBC: The first registration pathway will assess NDV-01 as an adjuvant treatment for patients who have undergone transurethral resection of bladder tumor. The trial will compare NDV-01 to observation, with disease-free survival as the primary outcome. Secondary measures include high-grade recurrence-free survival, progression-free survival, and quality of life. Approximately 75,000 U.S. patients fall into this intermediate-risk category each year, and currently, no approved adjuvant therapies are available.
• Second-Line Therapy in BCG-Unresponsive NMIBC: The second pathway will involve a single-arm study for patients with carcinoma in situ who have not responded to previous therapies and typically face radical cystectomy as their only option. The main endpoint will be complete response rate at any time, with additional measures such as duration of response, progression-free survival, and recurrence-free survival among responders. Relmada expects to launch the phase III RESCUE program in mid-2026, with initial three-month data from the second-line study anticipated by the end of 2026.

Relmada Therapeutics: Price Trends and Analyst Consensus

For more details on Relmada Therapeutics’ price trends and analyst consensus, visit the price-consensus chart or view the latest stock quote.

Analyst Ratings and Other Biotech Stocks to Watch

Relmada Therapeutics currently holds a Zacks Rank #3 (Hold).

Other biotech companies with higher Zacks ranks include:

• USANA Health Sciences (USNA) – Zacks Rank #1 (Strong Buy)
• Catalyst Pharmaceuticals (CPRX) – Zacks Rank #1 (Strong Buy)
• ALX Oncology Holdings (ALXO) – Zacks Rank #2 (Buy)

To view the full list of Zacks #1 Rank stocks, click here.

Recent Performance Highlights

• USANA Health Sciences: Over the past 60 days, 2026 EPS estimates increased from $1.90 to $2.00. The stock has declined 41.1% in the last six months. USANA exceeded earnings expectations in three of the last four quarters, with an average surprise of 21.92%.
• Catalyst Pharmaceuticals: 2026 EPS estimates rose from $2.55 to $2.82 in the past 60 days. Shares have climbed 23.5% over the last six months. The company beat earnings expectations in all four recent quarters, averaging a 35.19% positive surprise.
• ALX Oncology Holdings: Loss per share estimates for 2026 improved from $1.21 to $0.90 in the last 60 days. The stock has surged 104.7% in the past six months. However, ALX missed earnings estimates in each of the last four quarters, with an average negative surprise of 12.82%.

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