Investment research firm Leerink Partners recently revised its rating on Relmada Therapeutics Inc (NASDAQ:RLMD) shares, elevating the stock from Market Perform to Outperform, and increasing the price target from $1.00 to $8.00. This reassessment is strongly influenced by the anticipated prospects of the company’s bladder cancer treatment pipeline, specifically the drug candidate NDV-01. The stock has exhibited robust gains over the last twelve months with a 942% increase, although it has experienced an 18% decline since the start of the current year, according to data from InvestingPro.
This upgrade reflects Relmada’s significant strategic shift, following its decision to halt the development of REL-1017, a therapy aimed at depression, and the licensing agreement completed with Trigone in March 2025 involving NDV-01—a sustained-release intravesical gemcitabine/docetaxel formulation. Under this partnership, Trigone is entitled to a 3% royalty on net sales alongside up to $200 million in milestone payments. Currently, Relmada is unprofitable, reporting a diluted earnings per share of negative $1.77 over the past twelve months.
NDV-01 is being developed for two distinct therapeutic indications: treatment of second-line Bacillus Calmette-Guérin (BCG) unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) featuring carcinoma in situ, and as an adjuvant therapy following transurethral resection of bladder tumor (TURBT) in intermediate-risk NMIBC cases.
This drug candidate presents notable benefits over conventional gemcitabine/docetaxel therapies, including a significantly reduced administration duration—from approximately four hours down to five minutes—and sustained drug release spanning about ten days. Additionally, NDV-01 is provided in pre-filled syringes, potentially expanding its accessibility beyond specialized academic centers to broader community healthcare settings.
Market analysis by Leerink estimates the combined peak sales potential of these two indications to be around $2.3 billion in unadjusted terms, yielding a net present value close to $1.3 billion. These figures stand in marked contrast to Relmada’s current market capitalization, which rests near $290 million. Analyst target prices vary broadly between $1 and $10 per share, with the present trading price at $3.96 categorized as Fair Value per InvestingPro. The company exhibits a strong liquidity position, with a current ratio of 2.86 indicating that liquid assets comfortably cover short-term liabilities.
For investors seeking deeper insights, InvestingPro’s comprehensive Research Report offers detailed analysis and multiple ProTips on Relmada among more than 1,400 US-listed equities.
Further supporting optimism around Relmada’s oncology program, recent Phase 2 clinical data for NDV-01 revealed an impressive 92% complete response rate at nine months. Regulatory progress is also favorable; the FDA has provided constructive feedback endorsing a single-arm, open-label clinical trial design as appropriate for NDV-01’s registrational development pathway.
Additional buoying analyst sentiment, Mizuho recently upgraded Relmada to Outperform, assigning a $10.00 price target, while Jefferies initiated coverage with a Buy rating, noting the company’s focused transition towards oncology and neurology sectors. Executive changes have accompanied this strategic pivot, with updated contracts increasing salaries for key officers from January 1, 2026, reflecting management’s alignment with the company’s evolving priorities.
Overall, Relmada Therapeutics illustrates an ongoing transformation trajectory centered on its oncology pipeline, a strategy that has attracted growing analyst interest amid promising clinical and commercial prospects.