Shares of Innate Pharma (NASDAQ:IPHA) were soaring 19.5% higher as of 11:10 a.m. EST on Thursday. The big gain came after the company announced earlier in the day that the European Medicines Agency (EMA) has accepted the regulatory filing for Lumoxiti, a drug to treat hairy-cell leukemia (HCL).
Lumoxiti won Food and Drug Administration approval in September 2018 as a treatment for relapsed or refractory HCL. The EMA's acceptance of the Marketing Authorization Application for the drug is a major step for Innate in potentially expanding the global market for its flagship product. If it wins EMA approval, Lumoxiti would become the first new relapsed or refractory HCL treatment in more than two decades.
The news marked yet another milestone for Innate in recent months. In September 2019, the drugmaker and its big partner AstraZeneca (AZN -0.19%) announced plans to advance experimental drug monalizumab in combination with Erbitux to a late-stage clinical study targeting the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Innate also conducted an initial public offering (IPO) on the Nasdaq exchange in October.
Innate now must wait to see if Lumoxiti wins EMA approval. The company will also have to secure reimbursement for the drug (assuming it obtains approval) on a country-by-country basis in Europe.
Investors in biotech stocks are always looking for what's next. For Innate, the primary thing to watch other than what happens with Lumoxiti is the initiation of the late-stage study of monalizumab and Erbitux. Innate and AstraZeneca expect the clinical trial to begin this year.