Autolus Therapeutics

Obe-cel (Aucatzyl) CAR T-cell therapy demonstrated durable remissions in 77% of patients with relapsed or refractory B-cell ALL in the FELIX trial, with 55% achieving complete remission. Median event-free survival was 11.9 months, and overall survival was 15.6 months. Obe-cel showed low severe toxicity, supporting its safety and efficacy.

Terumo BCT launches Global Therapy Innovations unit to enhance patient access to advanced therapies. FDA approves PTC Therapeutics' gene therapy KEBILIDI for AADC deficiency, the first brain-administered gene therapy in the US. Autolus Therapeutics' CAR-T cell therapy AUCATZYL receives FDA approval for relapsed/refractory B-cell acute lymphoblastic leukemia in adults.

FDA approves Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) in adults, based on FELIX study results showing 40% complete response within 3 months and 60% overall. Aucatzyl targets CD19 on B cells, designed to reduce side effects, and does not require a REMS.

Autolus Therapeutics, a UCL spinout, received FDA approval for Obecabtagene autoleucel (obe-cel), a CAR-T cell therapy for adults with aggressive blood cancer, r/r B-ALL. Developed by UCL scientists led by Dr Martin Pule, obe-cel showed 63% overall complete remission in the FELIX trial, with a median duration of remission of 14.1 months. The therapy aims to overcome limitations of first-generation CAR-T therapies.

The FDA approved Autolus Therapeutics’ Aucatzyl (obe-cel) for adult r/r B-ALL, based on the FELIX trial results showing 63% overall complete remission. The therapy demonstrated favorable safety with low severe cytokine release syndrome rates and a 7% incidence of grade ≥ 3 immune effector cell-associated neurotoxicity syndrome.

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Autolus Therapeutics announces FDA approval of AUCATZYL® for adult B-cell Acute Lymphoblastic Leukemia, triggering a $30 million milestone payment from Blackstone. Q3 2024 financials show a cash position of $657.1 million, operating expenses of $67.9 million, and a net loss of $82.1 million. Marketing authorizations are under review with MHRA and EMA. Matthias Will appointed as Chief Development Officer; initial SLE Phase 1 study data expected in Q1 2025.

Syncona's Autolus Therapeutics received FDA approval for AUCATZYL® (obe-cel) for adult B-cell acute lymphoblastic leukemia treatment, triggering a $30M payment from Blackstone. Obe-cel is under EU and UK review, with Autolus advancing therapies through new data and management appointments.

FDA approves AUCATZYL, the first CAR T therapy without a REMS program, for adult r/r B-ALL based on FELIX trial results, showing 63% OCR and 42% CR within 3 months. AUCATZYL has low CRS and no Grade 4 or 5 events, with a boxed warning for CRS, neurologic toxicities, and secondary hematological malignancies.