Why Replimune Stock Was Soaring Today
Key Points
The biotech received the good news it was hoping for from a top national regulator.
This concerned RP1, its advanced melanoma drug.
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Biotech stocks can be volatile, a tendency that was very much in Replimune Group's (NASDAQ: REPL) favor on Monday. The biotech's stock had more than doubled in late-session action, thanks to some very positive news on the regulatory front. Its rise was easily eclipsing the S&P 500 index, which at that point was up by 1.1%.
A new try
Well before market open, Replimune announced that the U.S. Food and Drug Administration (FDA) accepted the resubmission of a crucial Biologics License Application (BLA). This was made for its RP1, an investigational drug that in combination with Bristol Myers Squibb's Opdivo targets advanced melanoma in certain patients.
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The FDA has set April 10, 2026 as its deadline for making a decision on the drug's approval.
Of the combination therapy, Replimune quoted its CEO Suhil Patel as saying that it "offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy."
It's good to talk
Replimune bulls charged back into the stock because this news erased the one factor hanging over the company's stock -- the FDA's complete response letter (essentially, notification that a drug application won't be approved as submitted).
The letter was sent in June, and was followed up by a mid-September meeting between the company and the FDA that, at first, appeared to be inconclusive. The regulator's acceptance Monday was a dramatic development in this saga, and a very positive one for the company.
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Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Bristol Myers Squibb. The Motley Fool recommends Replimune Group. The Motley Fool has a disclosure policy.
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