Replimune’s RP1 is being developed in combination with Bristol Myers Squibb’s Opdivo for advanced melanoma. The FDA had previously declined to approve the therapy, mainly due to concerns around the evidence package, including reliance on a single-arm study without a control group.

Now, Replimune says the FDA has agreed to treat the resubmission as an urgent matter and prioritise the review once received.

For traders, the key point is simple: when a biotech company gets a second or third chance with the FDA, the stock can reprice quickly because the market is no longer valuing only the failure scenario.

But this also brings risk. Biotech stocks often move on regulatory language, trial design, analyst interpretation and FDA timing. A positive pathway can create momentum, but it does not guarantee approval.