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 has announced a strategic collaboration with Blackstone Life Sciences, securing up to $250 million in financing to advance its investigational therapy, obe-cel, for adult acute lymphoblastic leukemia (ALL). The investment includes $150 million in product financing, with $50 million available at closing. Blackstone will also acquire $100 million in Autolus' American Depositary Shares. This funding aims to support clinical development and initial commercialization activities for obe-cel, which has shown potential as a curative treatment in a last-line setting.
Autolus Therapeutics plc (Nasdaq: AUTL) announced progress in its CAR T cell therapies, specifically obe-cel (AUTO1), at the 63rd ASH Annual Meeting in December 2021. The company will present an oral session on the industrialization of its Miltenyi Prodigy-Based manufacturing process and poster presentations on its AUTO1 programs for adult and pediatric Acute Lymphocytic Leukemia. A conference call is scheduled for December 14, 2021, to discuss ASH data. Autolus aims to enhance safety and efficacy through its innovative therapies designed to target cancer cells effectively.
Autolus Therapeutics (Nasdaq: AUTL) reported operational and financial results for Q3 2021, highlighting continued progress in clinical evaluations, particularly for obe-cel in the FELIX study. The expected delivery of primary endpoint data is slated for mid-2022. Cash at the end of Q3 totaled $173.1 million, down from $216.4 million in Q2 2021. The net loss attributable to ordinary shareholders was $34.0 million, an improvement from $37.3 million in 2020. The company anticipates key data presentations at the 63rd ASH Meeting in December 2021.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its plan to release third quarter 2021 financial results on November 3, 2021, before U.S. markets open. The company’s management will host a conference call at 8:30 am ET to discuss the financial results and provide a business update. Interested parties can access the webcast through the company’s events section on its website. The call can also be dialed in using provided numbers for U.S. and international callers with a reference conference ID of 6984737.
Autolus Therapeutics has received planning approval to construct a new manufacturing facility in Stevenage, UK, aimed at enhancing global commercial launch capacity for obe-cel (AUTO1). The 70,000 square foot facility will allow for GMP production of approximately 2,000 batches annually, with potential for expansion. The company anticipates pivotal data from the FELIX study in 2022 for treating adult patients with acute lymphoblastic leukemia (ALL). This new facility positions Autolus to secure its place in Europe's growing biotechnology sector.
Autolus Therapeutics (Nasdaq: AUTL) announced the appointment of John H. Johnson as non-executive chairman of its Board of Directors, effective September 15, 2021. Johnson, with over 30 years in the life sciences sector, previously held executive roles at Strongbridge Biopharma and major firms like Eli Lilly and Pfizer. The company is preparing for pivotal data on obe-cel, a CD19 CAR T cell therapy aimed at treating adult acute lymphoblastic leukemia, expected in 2022. This leadership change is seen as pivotal for advancing Autolus' clinical programs.
Novaremed AG has acquired Metys Pharmaceuticals AG in an all-share transaction, expanding its pipeline of non-opioid treatments for chronic pain. The acquisition includes two new development projects, allowing Novaremed to target neuropathic pain, including chemotherapy-induced peripheral neuropathy (CIPN). This move aligns with Novaremed's strategy to lead in non-opioid pain management. Additionally, Andrew J. Oakley has been appointed to the Board of Directors, enhancing the leadership team. Key objectives include advancing clinical studies and seeking further capital for development.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced its participation in three upcoming virtual investor conferences. These events include the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, the Wells Fargo Healthcare Conference on September 10 at 7:30 am ET, and the H.C. Wainwright & Co 23rd Annual Global Investment Conference on September 13 at 7:00 am ET. Audiences can access live audio webcasts of the presentations through the company's website, with archived versions available for a limited time.
Autolus is focused on developing innovative T cell therapies to treat various cancers.
Autolus Therapeutics has reported promising results from the Phase 1 ALLCAR19 clinical trial of its CD19 CAR-T therapy, obe-cel, published in the Journal of Clinical Oncology. The therapy is designed to minimize toxicity while enhancing patient response rates in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Notably, 85% of participants achieved minimal residual disease negative complete responses at one month, and no patients experienced severe cytokine release syndrome. The company plans to advance obe-cel into the pivotal FELIX study to further evaluate its efficacy.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, obe-cel, has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This designation acknowledges obe-cel's potential to significantly benefit adult patients with relapsed/refractory B-cell Acute Lymphocytic Leukemia (ALL). The ongoing FELIX Phase 1b/2 study is exploring its efficacy and safety, with promising implications for early access to treatment for patients with high unmet medical needs.