Replimune Looks to ASCO for a Rebound After FDA Setback

Replimune aims to rebuild investor confidence at ASCO with key survival data, after a second FDA rejection wiped out 64% of its stock value.

The biotech space is no stranger to dramatic reversals of fortune, and Replimune has lived through one of the most brutal in recent memory. Two months after a second FDA rejection wiped out nearly two-thirds of its market value in a single day, the company is betting that a strong showing at the American Society of Clinical Oncology (ASCO) annual meeting can begin the long process of rebuilding investor confidence.

A Pipeline on Display

Replimune has secured six presentations at the ASCO conference in Chicago, including two coveted oral slots. The centerpiece arrives on May 30, when the company will unveil three-year overall survival data from the IGNYTE study. That trial evaluates RP1 (Vusolimogene Oderparepvec) in combination with Bristol Myers Squibb's Nivolumab for melanoma patients who have failed to respond to anti-PD-1 therapies. In this difficult-to-treat population, durable long-term survival figures carry particular weight.

The following day, the final Phase 1 results for RP2 will be presented, covering safety, efficacy, and biomarker data from the first-in-human study, both as a monotherapy and in combination with Nivolumab. Four additional poster presentations round out the program, spanning studies in hepatocellular carcinoma, bile duct cancer, and other solid tumors, as well as data on intratumoral injection feasibility and randomized RP2 trials.

The Scale of the Damage

The stock has been trading in the $2.40 range, a far cry from its highs earlier in the year. The trigger was April 10, when the FDA issued a second Complete Response Letter for Replimune's marketing application for RP1 plus Nivolumab in melanoma, deeming the IGNYTE study insufficient to establish efficacy. The shares cratered roughly 64 percent in a single session.

The fallout was swift and severe. The company announced it would scale back its US operations, and a wave of analyst downgrades followed from H.C. Wainwright, JPMorgan, Jefferies, and others, with many price targets settling in the $2 to $4 range. Monday's 11 percent bounce to $2.69 on the ASCO announcement offered some relief, but it barely dented the losses from the FDA shock.

Cash Position Offers a Cushion

Despite the clinical and regulatory headwinds, Replimune's balance sheet provides a measure of breathing room. As of December 31, 2025, the company held approximately $124.7 million in cash, with short-term investments bringing total liquidity to roughly $269 million. Total liabilities stood at $123 million, giving the company a current ratio of 5.6.

The quarterly net loss came in at nearly $71 million, with operating cash burn of about $66 million. Based on current operating plans, management expects funding to carry operations into the first quarter of 2027.

The Pivot Begins

With the FDA door for RP1 in melanoma effectively closed for now, Replimune is repositioning its broader pipeline as the primary value driver. The ASCO presentations represent the first major clinical update since the regulatory blow, and the data disclosed on May 30 and 31 will go a long way toward determining whether the company can convince the oncology community — and its battered shareholder base — that there is still a viable path forward.