Shares of small-cap biotech Innate Pharma (NASDAQ: IPHA) are advancing strongly after the oncology-focused French biotech said the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application for Lumoxiti.
Lumoxiti is a CD22-directed immunotoxin and a first-in-class medicine, which has been approved in the U.S. for treating adult patients with relapsed or refractory hairy cell leukemia, who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.
The company had licensed Lumoxiti from AstraZeneca plc (NYSE: AZN).
The EMA filing is based on the final analysis of data from the pivotal Phase 3 trial of Lumoxiti, which was presented at ASH 2019.
"If approved by the EMA, Lumoxiti will be the first treatment available in Europe for relapsed or refractory hairy cell leukemia patients in more than twenty years, potentially changing the standard of care for these patients," said Pierre Dodion, EVP and Chief Medical Officer of Innate Pharma.
The FDA approved Lumoxiti in September 2018.
Innate Pharma shares traded higher by 22.75% to $7.89 at time of publication.