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 (AUTL) will present four abstracts at the ASH Annual Meeting 2024 in San Diego, featuring updates on obecabtagene autoleucel (obe-cel) for adult r/r B-ALL treatment. Key findings include: 84% of responders achieved MRD <10-6 leukemic cells, associated with better survival rates; bridging therapy with Inotuzumab ozogamicin (INO) effectively reduced disease burden; analysis of healthcare resource utilization for managing CRS and ICANS events; and correlation between CAR-HEMATOTOX scores and patient outcomes.
Autolus Therapeutics (Nasdaq: AUTL), a clinical-stage biopharmaceutical company focused on programmed T cell therapies, will release its third quarter 2024 financial results before US markets open on November 12, 2024. The company will host a conference call and webcast at 8:30 am EDT/1:30 pm BST, where management will discuss financial results and provide a business update. Participants must pre-register to receive dial-in details and a personal PIN for the call.
Autolus Therapeutics presented clinical data at the 2024 Lymphoma, Leukemia & Myeloma Congress, focusing on obecabtagene autoleucel (obe-cel) for relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). Key findings suggest:
1. Comparable outcomes for patients regardless of stem cell transplant (SCT) timing pre or post obe-cel, indicating no additional benefit from consolidative transplant.
2. Better outcomes when obe-cel was given as sole treatment to patients with lower tumor burden at lymphodepletion.
3. 78% of obe-cel infused patients achieved CR/CRi.
4. At median 21.5 months follow-up, 49% of responders without SCT were alive and in remission, compared to 28% of those who underwent SCT.
5. Lower tumor burden at lymphodepletion was associated with improved event-free survival in patients without SCT.
These results suggest potential for obe-cel treatment without consolidative SCT in a large subgroup of patients and highlight the importance of reducing tumor burden prior to lymphodepletion for improved outcomes.
Autolus Therapeutics plc (Nasdaq: AUTL) has appointed Dr. Matthias Will as Chief Development Officer, effective September 30, 2024. Dr. Will, joining from Dren Bio, Inc., brings extensive experience in pharmaceutical product development and regulatory milestones. CEO Dr. Christian Itin highlighted Dr. Will's track record and leadership skills as valuable assets for expanding the obe-cel opportunity in oncology and autoimmune diseases.
Dr. Will expressed excitement about joining Autolus as it prepares to commercialize obe-cel for relapsed/refractory adult B-ALL. His previous roles include leadership positions at CRISPR Therapeutics, CytomX Therapeutics, Gilead Sciences, and Novartis Oncology. Dr. Will's appointment aims to strengthen Autolus' development organization and advance its innovative portfolio in oncology.
Autolus Therapeutics (Nasdaq: AUTL) presented clinical data on obecabtagene autoleucel (obe-cel) for relapsed/refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL) at the SOHO Annual Meeting 2024. The FELIX Phase Ib/II study utilized a tumor burden (TB)-guided dosing strategy, resulting in high CAR T-cell expansion and manageable adverse events.
Key findings:
- 94% of patients received two planned doses
- Overall remission rates: 90% (low TB) and 75% (high TB)
- Peak expansion reached after Dose 2 in both groups
- 50% TB increase associated with 1.754-fold Cmax increase and 2.068-fold AUC0-28days increase
The data support the TB-guided dosing approach in adult r/r B-ALL, highlighting obe-cel's differentiation based on its unique binding properties.
Autolus Therapeutics (NASDAQ: AUTL) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. On track for potential US commercial launch of obe-cel with FDA PDUFA date of November 16, 2024.
2. MAA submitted to MHRA in UK for obe-cel in r/r adult B-ALL.
3. FELIX Phase 2 data showed durable responses, with 40% of patients in ongoing remission without subsequent stem cell transplant.
4. Cash position of $705.9 million as of June 30, 2024.
5. Total operating expenses increased to $58.9 million in Q2 2024 from $44.4 million in Q2 2023.
6. Net loss of $58.3 million for Q2 2024, compared to $45.6 million in Q2 2023.
7. Basic and diluted net loss per share of $0.22 for Q2 2024.
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.