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LONDON - Autolus Therapeutics plc (Nasdaq:AUTL) reported second quarter 2025 net product revenue of $20.9 million for its AUCATZYL therapy, with total revenue reaching $29.9 million for the first six months of the year, according to a press release statement.
The company recently secured conditional marketing authorization for AUCATZYL from both the UK Medicines and Healthcare products Regulatory Agency and the European Commission for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
Autolus reported having 46 fully activated treatment centers in the U.S. as of August 12, with patient access coverage secured for more than 90% of total U.S. medical lives.
The company presented updated long-term data from its FELIX trial at the 2025 European Hematology Association Congress, showing a median duration of response of 42.5 months for patients who responded to treatment. At a median follow-up of 32.8 months, 38.4% of responders remained in ongoing remission without requiring stem cell therapy or other treatments.
Autolus plans to initiate a Phase 2 pivotal clinical trial in lupus nephritis and a Phase 1 clinical trial in progressive forms of multiple sclerosis by the end of 2025.
Financial results showed a loss from operations of $61.2 million for the quarter ended June 30, 2025, compared to $58.9 million for the same period in 2024. The company’s cash, cash equivalents and marketable securities totaled $454.3 million as of June 30, 2025, down from $588.0 million at the end of 2024.
Autolus stated it is well capitalized to drive the launch and commercialization of obe-cel in r/r B-ALL and to obtain data in its planned lupus nephritis and multiple sclerosis trials.
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