Why Is RLMD Stock Surging Premarket? NDV-01 Trial Update and $160M PIPE Deal

Shares of Relmada Therapeutics, Inc. (NASDAQ: RLMD) are surging in premarket trading on Monday, March 9, 2026, following a pair of major announcements from the clinical-stage biotechnology company. The stock jumped roughly 80% in premarket after Relmada reported compelling 12-month interim data from its Phase 2 trial of NDV-01 in high-risk non-muscle invasive bladder cancer (NMIBC) and simultaneously announced an oversubscribed $160 million private placement financing.

The dual catalysts have drawn significant investor attention, with the company’s market cap sitting at approximately $326 million heading into the session. Together, these developments mark a pivotal inflection point for Relmada as it charts a path toward Phase 3 registration studies.

Phase 2 NDV-01 Trial Shows Strong Results in Bladder Cancer Patients

Relmada’s Phase 2 trial of NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel, delivered standout results in patients with high-risk non-muscle invasive bladder cancer. The trial demonstrated a 12-month complete response rate of 76% across the overall patient population, with 95% of patients achieving a complete response at any point during the study.

In the BCG-unresponsive subgroup, results were even stronger, with the 12-month CR rate reaching 80% and 94% achieving CR at any time. Critically, no patients in the trial experienced progression to muscle-invasive disease, and none required radical cystectomy, a significant outcome given the severity of this cancer type.

The safety profile was equally encouraging, with no Grade 3 or higher treatment-related adverse events and no treatment-related discontinuations reported. Among the 48 patients who received at least one dose, 63% experienced a treatment-related adverse event, with dysuria being the most common at 54%, followed by asymptomatic positive urine culture and hematuria, each at 8%.

Based on these results, Relmada plans to advance NDV-01 into the Phase 3 RESCUE registrational program beginning in mid-2026. The program will target two pathways: second-line BCG-unresponsive NMIBC and adjuvant intermediate-risk NMIBC. The company estimates the intermediate-risk market affects approximately 75,000 patients annually in the U.S., while BCG-unresponsive NMIBC with carcinoma in situ impacts around 5,000 patients per year — representing a meaningful commercial opportunity if Phase 3 results hold.

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$160M Private Placement and RLMD Stock Brief

Alongside the clinical data, Relmada announced an oversubscribed private investment in public equity financing expected to generate gross proceeds of approximately $160 million. The company is selling 29,474,569 shares of common stock at $4.75 per share, along with pre-funded warrants to purchase an additional 4,210,527 shares at $4.749 per warrant.

The financing is expected to close on or about March 11, 2026, with Jefferies, Leerink Partners, Piper Sandler, and Mizuho acting as placement agents. Proceeds are earmarked for working capital, general corporate purposes, and advancement of the company’s R&D pipeline, with the capital raise expected to extend the company’s runway into 2028.

As of premarket trading on March 9, 2026 at approximately 8:09 AM EDT, RLMD shares were quoted at $8.02, up $3.57 or roughly 80% from the prior close of $4.45. The stock’s 52-week range spans from $0.24 to $5.12, meaning today’s premarket move would push shares to new 52-week highs. Average daily trading volume stands at approximately 676,000 shares, and the company carries a market cap of roughly $326 million based on Friday’s close.

The 1-year analyst price target average sits at $10.75, with the high target at $14.00, both now within closer reach following today’s catalysts. From a broader performance perspective, RLMD has delivered a remarkable 1-year return of over 1,530% as of March 6, 2026, dramatically outpacing the S&P 500’s roughly 17% gain over the same period.

The most recent analyst action came from Lucid Capital Markets, which initiated coverage on March 2, 2026 with a Buy rating and a $14.00 price target. While the company currently generates no revenue and carries ongoing losses, with a trailing EPS of -$1.78, the strong NDV-01 data and fresh capital infusion provide a clearer runway toward potential commercialization and continued clinical milestones.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.