Replimune Faces Setback in Skin Cancer Trial

Shares of Replimune Group Inc. (NASDAQ: REPL) plummeted more than 40% in premarket trading on Tuesday following disappointing results from a clinical trial for an investigational cancer therapy. The therapy, known as RP1, was tested in combination with cemiplimab, a monoclonal antibody marketed as Libtayo by Regeneron Pharmaceuticals Inc. (NASDAQ: REGN).

Although the combination therapy showed promising improvements in both response rate and duration for patients with cutaneous squamous cell carcinoma, it fell short of achieving the study's statistical significance threshold for complete response rate. Despite this setback, Replimune remains committed to continuing the trial to evaluate overall survival and other important factors.

In light of this development, Replimune has made the decision to discontinue the development of its investigational RP2 and RP3 therapies for both squamous cell carcinoma of the head and neck and colorectal cancer. The company believes that this strategic reallocation of resources will extend its cash runway to early 2026, leveraging its current financial strength. As of September 30th, Replimune reported cash and investments totaling $496.8 million.

While Replimune shares have experienced a decline of 55% year-to-date, it's worth noting that the broader S&P 500 index has witnessed a gain of 19% during the same period.

This setback underscores the challenging nature of clinical trials and the inherent risks involved in developing innovative therapies for cancer treatment. Replimune remains dedicated to advancing its pipeline and exploring new possibilities to address unmet medical needs in oncology.