Welcome to our dedicated page for AUTOLUS THERAPEUTICS PLC news (Ticker: AUTL), a resource for investors and traders seeking the latest updates and insights on AUTOLUS THERAPEUTICS PLC stock.
Autolus Therapeutics plc (Nasdaq: AUTL) generates frequent news as an early commercial-stage biopharmaceutical company focused on next-generation programmed T cell therapies for cancer and autoimmune disease. News coverage for AUTL often centers on AUCATZYL® (obecabtagene autoleucel; obe-cel), the company’s CD19-directed CAR T cell therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), and on the clinical and commercial progress of this product.
Investors and healthcare observers following Autolus news will see updates on AUCATZYL net product revenue, treatment center activation, and reimbursement developments such as NICE recommendations and conditional marketing authorizations in the UK and EU. Press releases also describe real-world data from consortia like ROCCA, which evaluate safety and response rates for AUCATZYL in clinical practice, alongside analyses from the FELIX study that explore CAR T-cell persistence and product cell phenotypes as potential predictors of long-term outcomes.
Autolus regularly reports clinical data from its broader pipeline, including the CATULUS trial in pediatric relapsed or refractory B-ALL, the CARLYSLE Phase 1 study in severe refractory systemic lupus erythematosus, the LUMINA Phase 2 trial in lupus nephritis and the BOBCAT trial in progressive multiple sclerosis. These updates typically highlight remission rates, safety profiles, B-cell depletion and immune reset signals in autoimmune indications. Additional news items cover collaborations, such as the evaluation of Cellares’ automated Cell Shuttle platform to support high-throughput CAR T manufacturing, and corporate developments including leadership appointments and participation in healthcare conferences.
This news page allows readers to track Autolus’ ongoing clinical milestones, regulatory and reimbursement decisions, manufacturing initiatives and financial disclosures related to its T cell therapy programs. For those monitoring AUTL, the flow of updates provides context on how AUCATZYL and pipeline candidates are progressing across hematologic malignancies, solid tumors and autoimmune diseases.
Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies, has announced its plans to release second quarter 2024 financial results and operational highlights. The release is scheduled for Thursday, August 8, 2024, before US markets open. Following the release, the company will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the financial results and provide a general business update. Interested participants are advised to pre-register for the conference call to receive dial-in numbers and a personal PIN. An audio webcast and replay will also be available on the events section of Autolus' website.
Autolus Therapeutics (Nasdaq: AUTL) will present three clinical updates on the therapy obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) at the European Hematology Association (EHA) Congress from June 13-16, 2024. Key data from the FELIX study indicate a 78% overall response rate (ORR) with median follow-up of 21.5 months, stabilizing long-term survival rates around 40%. Additional findings suggest the effectiveness of INO-containing bridging therapy and the sensitivity of ddPCR in monitoring CAR T persistence.
The median event-free survival (EFS) was 11.9 months and overall survival (OS) was 23.8 months, with 12-month EFS and OS rates at 49.5% and 61.1%, respectively. INO-containing therapies showed reduced bone marrow disease and minimized risks without increasing liver toxicity, while ddPCR proved more sensitive in monitoring CAR T-cell levels compared to flow cytometry.
Autolus Therapeutics announced longer-term follow-up and additional data from the pivotal Phase 1b/2 FELIX study of obe-cel for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). Presented at ASCO 2024, the data revealed that 40% of patients remain in remission without further therapy, showing potential long-term survival benefits. Median overall survival (OS) was 23.8 months, and median event-free survival (EFS) was 11.9 months. The FDA BLA submission has a target action date of November 16, 2024. The results support obe-cel as a standalone therapy with CAR T persistence linked to improved outcomes.
Autolus Therapeutics (NASDAQ: AUTL) reported its Q1 2024 financial results, highlighting key developments and financial metrics. The company is progressing with its regulatory review processes for obe-cel in relapsed/refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) with the FDA and European Medicines Agency (EMA). Key milestones include longer follow-up data from the FELIX Phase 2 trial, initial data from the CARLYSLE Phase 1 trial for Systemic Lupus Erythematosus (SLE) expected by late 2024, and the strategic CAR T cell therapy collaboration with BioNTech. Financially, the company reported cash and cash equivalents totaling $758.5 million as of March 31, 2024. Operating expenses were $38.8 million, with a net loss of $52.7 million for the quarter.
Autolus Therapeutics (Nasdaq: AUTL) announced the publication of three abstracts for the upcoming 2024 European Hematology Association (EHA) Congress, set for June 13-16, 2024. The studies focus on obecabtagene autoleucel (obe-cel) for treating relapsed/refractory B-Cell acute lymphoblastic leukemia. Key presentations include:
- An oral presentation by Dr. Claire Roddie on survival rates and CAR-T cell persistence in the FELIX study.
- A poster by Dr. Jae H. Park discussing the effects of inotuzumab-containing bridging therapy.
- Another poster by Dr. Claire Roddie on the sensitivity of droplet digital PCR and flow cytometry in measuring CAR-T cell kinetics.
Autolus Therapeutics plc, a biopharmaceutical company, has delayed its first quarter 2024 earnings release and conference call. The company will file a Form 12b-25 for an extension to file its Quarterly Report on Form 10-Q. The earnings release and call scheduled for May 14, 2024, are canceled, with the Q1 2024 10-Q expected to be filed by May 20, 2024. The conference call is rescheduled to May 17, 2024, for discussing financial results.
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