Advertisement. Remove ads.
Nasdaq-listed shares of Autolus Therapeutics PLC (AUTL) were in the spotlight on Friday after the company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) approve its Obe-cel therapy for the treatment of a particular type of blood cancer.
Obe-cel is short for Obecabtagene Autoleucel. The CHMP has recommended that the European Commission approve it for the treatment of adult patients over the age of 26 with relapsed or refractory B-cell precursor acute Lymphoblastic Leukemia, an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs.
According to Autolus, there are about 6,000 new cases of acute Lymphoblastic Leukemia diagnosed every year in Europe.
The committee’s recommendation was based on the results of the company’s open-label, multiple-centre study and will serve as the basis for the commission’s final decision on Autolus’ marketing authorization application.
The European Commission's decision will apply to all 27 European Union Member States, Iceland, Norway, and Liechtenstein.
Obe-cel received approval from the U.S. Food and Drug Administration in November 2024 and conditional marketing authorization from the U.K.’s Medicines and Healthcare Products Regulatory Agency in April.
On Stocktwits, retail sentiment around AUTL improved from ‘bearish’ to ‘neutral’ territory over the past 24 hours while message volume remained at ‘neutral’ levels.
A Stocktwits user expressed optimism about the therapy receiving approval in the EU.
AUTL stock is down by about 42% this year and 61% over the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.