Biotech stocks can be volatile, a tendency that was very much in Replimune Group's (REPL 4.24%) 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.
Image source: Getty Images.
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."
NASDAQ: REPL
Key Data Points
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.
