由于试验设计问题,FDA停止批准新的黑素瘤治疗RP1,导致Replimune的库存急剧下降。 FDA halts approval of new melanoma treatment RP1 due to trial design issues, causing Replimune’s stock to plummet.

美国食品和药物管理局已向Replimune发布完整回应信,停止批准他们的黑色素瘤治疗,RP1,与nivolumab结合,理由是IGNYTE试验的设计和患者多样性存在问题. The FDA has issued a Complete Response Letter to Replimune, halting the approval of their melanoma treatment, RP1, combined with nivolumab, citing issues with the IGNYTE trial's design and patient diversity. 尽管反应率为33.6%且副作用很少,但FDA认为试验的控制不充分. Despite a 33.6% response rate and low adverse effects, the FDA deemed the trial inadequately controlled. 消息传出后，Replimune 的股价下跌了 76% 以上，该公司计划与 FDA 会面以获得潜在的加速批准。 Replimune's stock dropped over 76% following the news, and the company plans to meet with the FDA for potential accelerated approval.