Innate Pharma S.A. (IPHA - Free Report) announced that the European Medicines Agency (EMA) has accepted its marketing authorization application (MAA) for its first-in-class medicine Lumoxiti. The company is seeking approval of Lumoxiti for the treatment of relapsed or refractory hairy cell leukemia (HCL) in adult patients who have received at least two prior systemic therapies including treatment with a purine nucleoside analog.
Rights to Lumoxiti were recently in-licensed by Innate from UK-based pharma giant AstraZeneca PLC (AZN - Free Report) . Upon submission of the MAA filing in Europe, Innate is entitled to pay a regulatory-based milestone fee of $15 million to AstraZeneca.
Lumoxiti is already marketed in the United States for the same indication in the given patient population. The drug was approved by the FDA in September 2018.
The regulatory filing in Europe was based on data from a pivotal phase III study of Lumoxiti. Data from the study showed that 36% of the patients treated with Lumoxiti achieved durable complete response defined as CR with a hematological remission maintained for minimum 180 days. The objective response rate (ORR) was 75% while 81% of patients with CR experienced eradication of minimal residual disease as reflected by MRD-negative status. Moreover, there was 61% probability that patients who achieved CR would maintain it even after five years
Shares of Innate rallied 13.5% following the EMA’s acceptance of the marketing application for Lumoxiti on Thursday.
If approved, Lumoxiti will become the first medicine to get the nod for relapsed/refractory HCL patients in Europe in more than 20 years. This can potentially change the standard of care for the given patient population.
We remind investors that shares of Innate started trading under the ticker symbol IPHA after the company completed its initial public offering in October 2019 on the Nasdaq stock exchange.
Per the company, AstraZeneca currently holds the biologics license application (BLA) for Lumoxiti in the United States and has been responsible for its commercialization. It was also responsible for filing the marketing application in Europe.
Zacks Rank & Stocks to Consider
Innate currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include NuCana PLC (NCNA - Free Report) and Agenus Inc. (AGEN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
NuCana’s loss per share estimates have narrowed 22.4% for 2020 over the past 60 days.
Agenus’ loss per share estimates have narrowed 13.5% for 2020 over the past 60 days. The stock has surged 36.1% in the past year.
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