UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 14, 2024 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane Lon ...

Core Insights - Autolus Therapeutics plc has received Manufacturer's Importation Authorisation (MIA) and a GMP certificate for its Nucleus manufacturing facility, enabling global commercial and clinical product supply starting March 18, 2024 [1][2] - The MHRA inspection found no major or critical observations, indicating a successful certification process for both clinical and commercial manufacturing [1][2] Company Overview - Autolus is a clinical-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [3] - The company has a pipeline targeting hematological malignancies, solid tumors, and autoimmune diseases [3] Product Development - Obe-cel, an investigational CD19 CAR T cell therapy, has received multiple designations including Orphan Drug Designation from the FDA and EMA, and RMAT designation from the FDA for adult relapsed/refractory B-ALL [2][4] - Clinical trials for obe-cel have shown a "fast off-rate" profile that reduces toxicity and T cell exhaustion, leading to improved persistence and durable remissions in patients [4] Clinical Trials - The Phase Ib/II clinical trial of obe-cel enrolled over 100 patients across 30 leading centers in the US, UK, and Europe, focusing on overall response rate and safety [5]

LONDON, March 11, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a publication in Blood Cancer Journal entitled ‘Dual T-cell constant β chain (TRBC)1 and TRBC2 staining for the identification of T-cell neoplasms by flow cytometry.' 1 Diagnosing leukemic T-cell malignancies poses challenges due to their resemblance to reactive T-cells. In the paper published by Pedro Horna of M ...

Autolus Therapeutics PLC Sponsored ADR (AUTL) shares soared 6.3% in the last trading session to close at $6.38. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 17.7% loss over the past four weeks.The sudden surge in the stock price can be attributed to the positive investor mindset regarding Autolus’ CAR T cell pipeline. The company is also currently looking to advance and expand the same through strategic initiatives. Last week, ...

LONDON, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the pricing of an underwritten offering in the United States of 58,333,336 American Depositary Shares ("ADSs") representing 58,333,336 ordinary shares at a public offering price of $6.00 per ADS, for total gross proceeds of $350 million. All ADSs sold in the offering were offered by Autolus. Autolus intends to use ...

Strategic alliance leverages manufacturing and commercial infrastructure as well as technology with the aim to advance both companies' autologous CAR-T programs towards market, pending market authorization BioNTech secures the right to utilize Autolus' manufacturing capacity in a cost-efficient set-up to accelerate the development of BNT211 into pivotal trials in CLDN6+ tumors BioNTech to support launch and expansion of development program of Autolus' lead cell therapy candidate obe-cel and will receive a r ...

Fly View Productions My initial coverage of Autolus Therapeutics (NASDAQ:AUTL), now a $1 billion market cap clinical-stage biopharmaceutical company, rated it a Strong Buy for numerous positive catalysts for 2023. Investors who heeded this tip were rewarded, as the stock has skyrocketed nearly 150% to a 52-week high of $7.45 since publication. Shares have dipped about 20% after the FDA required black box warnings (“BBW”) for certain cell therapies to reflect a risk of T-cell malignancies. Most of Autolu ...

LONDON, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced a publication in ACS Chemical Biology1 entitled: ‘Designer small molecule control system based on Minocycline induced disruption of protein-protein interaction.' 1 Cell-based therapies have become increasingly complex and are being used to treat a wide range of diseases such as cancer and autoimmunity. However, ce ...

PDUFA Goal date is November 16, 2024Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel) for patie ...

Table of contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number 001-38547 AUTOLUS THERAPEUTICS PLC (Exact name of registrant as specified in its charter ...