US Stock Market Move | After being rejected by the FDA twice, Replimune (REPL.US) skin cancer drug sees a turnaround with its stock price skyrocketing over 77%.

On Friday, Replimune (REPL.US) stock price surged, rising over 77% to reach $8.27 as of the time of writing. In terms of news, Replimune stated in a release that it has reached an agreement with the Food and Drug Administration (FDA) on the path forward, and will resubmit its application for the approval of its late-stage melanoma treatment drug. The FDA has pledged to review this submission as an "urgent matter". In April of this year, the FDA rejected Replimune's combination therapy for late-stage melanoma for the second time, which combined the company's proprietary immunotherapy with another cancer drug. In recent weeks, there have been major changes in leadership at the FDA, with the most notable being the resignation of director Matti Makari. The FDA's decision to reconsider Replimune's application is widely seen as a signal that the agency's tough stance on drug reviews may be softening. As of the close of trading on Thursday, Replimune's stock price had fallen by 52% for the year. Following the opening of the New York market on Friday, the stock price rebounded significantly, reaching a high increase of 82%. BMO Capital Markets analyst Evan Seigerman noted in a research report that the FDA's "reversal may reflect its desire to correct some of the unpopular decisions made during Makari's tenure". However, he remains cautious about Replimune's application, as "besides the change in leadership at the FDA, we are not sure what actual changes have taken place". The fate of Replimune's melanoma therapy has been closely watched by investors in the biotechnology sector. The recent rejections of multiple drug applications by the FDA have raised concerns in the industry. It is worth noting that another company, UniQure NV (QURE.US), which has controversial gene therapy for Huntington's disease, also saw a 19% increase in its stock price after the market opened on Friday.