TLDR
- Relmada Therapeutics stock surged ~31% in pre-market trading Monday after two major announcements
- Interim Phase 2 trial data for NDV-01, a bladder cancer treatment, showed a 76% 12-month complete response rate
- The company priced an oversubscribed $160 million private placement at $4.75 per share
- The PIPE includes 29.47 million common shares and pre-funded warrants for another 4.21 million shares, closing March 11
- Wall Street analysts have a Strong Buy consensus on RLMD with an average price target of $10.25
The first was interim clinical data from its Phase 2 trial of NDV-01, a treatment for high-risk non-muscle invasive bladder cancer (NMIBC). The results showed a 12-month complete response rate of 76%, with a favorable side effect profile. The drug also hit that response rate threshold in the BCG-unresponsive patient population specifically.
$RLMD reported 12-month interim Phase 2 data for NDV-01 in high-risk non-muscle invasive bladder cancer showing a 76% complete response rate at 12 months (95% at any time) and 80% CR at 12 months in BCG-unresponsive patients with no ≥Grade 3 treatment-related adverse events,… pic.twitter.com/nVX9bERNcH
— BioPharmCatalyst (@BPharmCatalyst) March 9, 2026
Raj S. Pruthi, MD, Chief Medical Officer of Oncology at Relmada, called the data “meaningful clinical validation” of the program.
Relmada Therapeutics, Inc., RLMD
The company said it plans to advance NDV-01 into a registrational Phase 3 trial called the RESCUE program, with two separate pathways: BCG-unresponsive patients and adjuvant intermediate-risk patients. That Phase 3 is expected to kick off in mid-2026.
$160 Million PIPE
Alongside the trial data, Relmada announced it had priced an oversubscribed $160 million private placement.
The deal involves selling 29,474,569 common shares at $4.75 each, plus pre-funded warrants for an additional 4,210,527 shares priced at $4.749 with a $0.001 exercise price.
Jefferies, Leerink Partners, Piper Sandler, and Mizuho are acting as placement agents. The deal is expected to close on March 11, 2026, subject to standard conditions.
Proceeds from the raise are earmarked for working capital and advancing the company’s R&D programs.
As part of the deal, investors were granted resale registration rights. Relmada committed to timely SEC filings, with liquidated damages of 1.0% per 30-day period if deadlines are missed, subject to caps.
Stock Movement
RLMD was up 31.01% in pre-market trading on Monday. The stock had already posted a slight gain on Friday.
Year-to-date, the stock is still down 7.87%. Over the past 12 months, however, it has gained 1,536%.
Trading volume surged with the news. More than 7.9 million shares changed hands on Monday, well above the three-month average daily volume of around 570,000.
That kind of volume gap — over 13x the average — shows just how much attention the two announcements drew from the market.
On Wall Street, the current analyst consensus on RLMD is Strong Buy, based on four Buy ratings issued over the past three months.
The average price target sits at $10.25, which would represent upside of around 130% from current levels.
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