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RLMD Stock Surges 42% in a Week: Here's What You Should Know
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Key Takeaways
RLMD shares surged 42% in a week after positive 12-month interim phase II data for NDV-01 in NMIBC patients.
NDV-01 showed a 76% 12-month CR rate, with 87%, 86% and 85% CR rates at three, six and nine months.
RLMD plans phase III RESCUE studies in two NMIBC settings, with program initiation expected in mid-2026.
Shares of Relmada Therapeutics (RLMD - Free Report) rallied 42% in a week after the company announced positive 12-month interim data from its ongoing mid-stage study evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC). RLMD’s NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel.
Per the data readout, the phase II study of the candidate demonstrated a 12-month complete response (CR) rate of 76%. Response rates remained relatively durable over time, with CR rates of 87% at three months, 86% at six months and 85% at nine months. Over 12 months, 95% of evaluable patients achieved a complete response at some point during treatment.
The therapy also showed promising activity in the difficult-to-treat BCG-unresponsive population. In this subgroup, NDV-01 achieved a 12-month CR rate of 80%. Interim data further indicated that none of the treated patients experienced progression to muscle-invasive disease or required radical cystectomy, supporting continued development of NDV-01. Based on these results, Relmada Therapeutics plans to advance the candidate into the phase III RESCUE registrational program targeting both second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC settings.
Additionally, NDV-01 demonstrated a favorable safety profile in the phase II study. Treatment-related adverse events were mostly mild to moderate in severity and no discontinuations due to adverse events were reported. These findings suggest that NDV-01 was generally well tolerated in the treated population.
In the past six months, Relmada Therapeutics shares have skyrocketed 278.4% against the industry’s 6.4% decline.
Image Source: Zacks Investment Research
RLMD's Next Steps in the Bladder Cancer Program
Earlier this year, Relmada Therapeutics reported gaining FDA alignment on two potential registrational pathways for NDV-01, paving the way for the phase III RESCUE program. The company plans to pursue development across two distinct NMIBC settings, targeting both intermediate-risk patients following tumor removal and those with BCG-unresponsive disease who have limited treatment options. The encouraging phase II results further support the potential best-in-class profile of NDV-01 and support its advancement into late-stage development for both indications.
The first registrational pathway will evaluate NDV-01 as an adjuvant therapy for intermediate-risk NMIBC patients after transurethral resection of bladder tumor. This study will compare NDV-01 with observation, with disease-free survival as the primary endpoint. Secondary endpoints will include high-grade recurrence-free survival (RFS), progression-free survival (PFS) and quality-of-life measures. Relmada Therapeutics estimates that roughly 75,000 patients annually, in the United States, fall into this intermediate-risk category, where no approved adjuvant therapies currently exist.
The second pathway will focus on a single-arm study in second-line BCG-unresponsive NMIBC patients with carcinoma in situ who have failed prior therapies and often face radical cystectomy as the only remaining option. The primary endpoint for this study will be CR rate at any time, with secondary measures including duration of response, PFS and RFS among responders. RLMD expects to initiate the phase III RESCUE program in mid-2026, with initial three-month data from the second-line BCG-unresponsive study anticipated by year-end 2026.
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Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.82. CPRX shares have soared 23.5% over the past six months.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ALX Oncology Holdings’ 2026 loss per share have narrowed from $1.21 to 90 cents. ALXO shares have rallied 104.7% over the past six months.
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RLMD Stock Surges 42% in a Week: Here's What You Should Know
Key Takeaways
Shares of Relmada Therapeutics (RLMD - Free Report) rallied 42% in a week after the company announced positive 12-month interim data from its ongoing mid-stage study evaluating NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC). RLMD’s NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel.
Per the data readout, the phase II study of the candidate demonstrated a 12-month complete response (CR) rate of 76%. Response rates remained relatively durable over time, with CR rates of 87% at three months, 86% at six months and 85% at nine months. Over 12 months, 95% of evaluable patients achieved a complete response at some point during treatment.
The therapy also showed promising activity in the difficult-to-treat BCG-unresponsive population. In this subgroup, NDV-01 achieved a 12-month CR rate of 80%. Interim data further indicated that none of the treated patients experienced progression to muscle-invasive disease or required radical cystectomy, supporting continued development of NDV-01. Based on these results, Relmada Therapeutics plans to advance the candidate into the phase III RESCUE registrational program targeting both second-line BCG-unresponsive and adjuvant intermediate-risk NMIBC settings.
Additionally, NDV-01 demonstrated a favorable safety profile in the phase II study. Treatment-related adverse events were mostly mild to moderate in severity and no discontinuations due to adverse events were reported. These findings suggest that NDV-01 was generally well tolerated in the treated population.
In the past six months, Relmada Therapeutics shares have skyrocketed 278.4% against the industry’s 6.4% decline.
Image Source: Zacks Investment Research
RLMD's Next Steps in the Bladder Cancer Program
Earlier this year, Relmada Therapeutics reported gaining FDA alignment on two potential registrational pathways for NDV-01, paving the way for the phase III RESCUE program. The company plans to pursue development across two distinct NMIBC settings, targeting both intermediate-risk patients following tumor removal and those with BCG-unresponsive disease who have limited treatment options. The encouraging phase II results further support the potential best-in-class profile of NDV-01 and support its advancement into late-stage development for both indications.
The first registrational pathway will evaluate NDV-01 as an adjuvant therapy for intermediate-risk NMIBC patients after transurethral resection of bladder tumor. This study will compare NDV-01 with observation, with disease-free survival as the primary endpoint. Secondary endpoints will include high-grade recurrence-free survival (RFS), progression-free survival (PFS) and quality-of-life measures. Relmada Therapeutics estimates that roughly 75,000 patients annually, in the United States, fall into this intermediate-risk category, where no approved adjuvant therapies currently exist.
The second pathway will focus on a single-arm study in second-line BCG-unresponsive NMIBC patients with carcinoma in situ who have failed prior therapies and often face radical cystectomy as the only remaining option. The primary endpoint for this study will be CR rate at any time, with secondary measures including duration of response, PFS and RFS among responders. RLMD expects to initiate the phase III RESCUE program in mid-2026, with initial three-month data from the second-line BCG-unresponsive study anticipated by year-end 2026.
Relmada Therapeutics, Inc. Price and Consensus
Relmada Therapeutics, Inc. price-consensus-chart | Relmada Therapeutics, Inc. Quote
RLMD’s Zacks Rank & Stocks to Consider
Relmada Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are USANA Health Sciences (USNA - Free Report) , Catalyst Pharmaceuticals (CPRX - Free Report) and ALX Oncology Holdings (ALXO - Free Report) . While USNA and CPRX sport a Zacks Rank #1 (Strong Buy) each, ALXO carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for USANA Health Sciences’ 2026 earnings per share (EPS) have risen from $1.90 to $2.00. USNA shares have lost 41.1% over the past six months.
USANA Health Sciences’ earnings beat estimates in three of the trailing four quarters and matched once, with the average surprise being 21.92%.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.82. CPRX shares have soared 23.5% over the past six months.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ALX Oncology Holdings’ 2026 loss per share have narrowed from $1.21 to 90 cents. ALXO shares have rallied 104.7% over the past six months.
ALX Oncology Holdings’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 12.82%.