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Autolus Therapeutics plc reports news on its commercial-stage biopharmaceutical business developing, manufacturing and delivering next-generation programmed T cell therapies. Updates center on AUCATZYL (obecabtagene autoleucel, or obe-cel), product revenue, manufacturing capacity, gross margin plans and the company’s acute lymphoblastic leukemia business.
Company announcements also cover clinical programs using obe-cel and related T cell therapy candidates in pediatric relapsed/refractory acute lymphoblastic leukemia, lupus nephritis and progressive multiple sclerosis. Other recurring items include financial results, operational efficiency actions, investor presentations, Nasdaq inducement equity grants and ADR-related public-company disclosures.
Autolus (Nasdaq: AUTL) announced five abstracts for presentation at the ASH Annual Meeting (Dec 6-9, 2025) detailing clinical updates for obe-cel (obecabtagene autoleucel) across autoimmune and hematologic indications.
Key points: Phase I CARLYSLE data in severe refractory SLE show pronounced CAR T expansion, deep B-cell depletion and clinical benefit; pediatric CATULUS trial reports ORR 95% and ~90% ongoing remissions at cutoff; drug-product phenotypes (higher Tcm) correlated with improved OS; Month 3 CAR T persistence predicts longer EFS/OS; commercially available reagents can track obe-cel but CD19-based reagents are unsuitable.
Autolus Therapeutics (Nasdaq: AUTL) will release its third quarter 2025 financial results and operational highlights before U.S. market open on Wednesday, November 12, 2025. Management will host a conference call and webcast at 8:30 AM EST / 1:30 PM GMT to discuss results and provide a business update. Participants must pre-register to receive dial-in numbers and a personal PIN required for access. A simultaneous audio webcast and a replay will be available from the events section of Autolus’ investor website.
Autolus Therapeutics (NASDAQ: AUTL)/b) presented follow-up data from the Phase 1 CARLYSLE study of obe-cel in severe refractory systemic lupus erythematosus (srSLE) on Oct 27, 2025. As of Aug 21, 2025, six patients received the target dose of (±20%) with median follow-up of 8.9 months (range 6.0–13.8).
Key findings: no DLTs, no ICANS, no Grade ≥2 CRS; remission by DORIS in 83.3% (5/6); complete renal response in 50% (3/6); all patients tapered steroids to ≤5 mg/day; deep B-cell depletion followed by naïve B-cell reconstitution. Company expects to dose first Phase 2 LN patient before year-end 2025 and reports alignment with the FDA on trial design.
Autolus Therapeutics (Nasdaq: AUTL) announced dosing of the first patient in the Phase 1 BOBCAT trial of obecabtagene autoleucel (obe-cel) for progressive multiple sclerosis (PMS) on Oct 20, 2025. The trial, led at University College London Hospitals, will enroll up to 18 adults with refractory progressive MS to evaluate safety, tolerability and collect preliminary efficacy and biological-effect data using change-from-baseline standard measures. Autolus highlights obe-cel’s fast-off rate CAR design and notes the therapy has been studied in more than 400 patients to date and is approved in certain regions for adult relapsed/refractory B-ALL.
This dosing marks an early clinical milestone as the company explores a one-time CAR T approach for an unmet need in PMS.
Autolus Therapeutics (Nasdaq: AUTL) announced inducement stock option awards under its 2025 Inducement Plan on October 15, 2025.
The Compensation Committee granted options to purchase an aggregate of 1,093,300 shares to 65 employees. Options carry an exercise price of $1.49, equal to the closing price on October 7, 2025, have a 10-year term, and vest over four years (25% at one year, then 36 equal monthly installments), subject to continued service. Grants were made as inducements pursuant to Nasdaq Listing Rule 5635(c)(4).
Autolus Therapeutics (Nasdaq: AUTL) has announced it will present updated clinical data from its CARLYSLE study at the upcoming American College of Rheumatology (ACR) Convergence 2025, scheduled for October 24-29 in Chicago.
The presentation will focus on obecabtagene autoleucel (obe-cel), a CD19-targeting CAR T-cell therapy, in treating patients with severe refractory systemic lupus erythematosus (srSLE). Initial findings demonstrate a favorable safety profile with no dose limiting toxicities, no ICANS, and no Grade ≥2 cytokine release syndrome. The study showed SLEDAI-2K score improvements and clinical benefits across all patients, with three patients achieving complete renal response.
Autolus Therapeutics (NASDAQ:AUTL) reported Q2 2025 financial results, highlighting $20.9 million in AUCATZYL® net product revenue and $29.9 million for H1 2025. The company received conditional marketing authorizations from both UK MHRA and European Commission for AUCATZYL®. Key developments include 46 activated U.S. centers and coverage for >90% of U.S. medical lives.
Updated FELIX trial data showed promising 42.5-month median duration of response for obe-cel in r/r B-ALL, with 38.4% of responders maintaining remission. The company plans to initiate Phase 2 pivotal trial in lupus nephritis and Phase 1 trial in progressive MS by year-end 2025.
Financial position remains strong with $454.3 million in cash and equivalents. Q2 2025 net loss was $47.9 million ($0.18 per share), compared to $58.3 million ($0.22 per share) in Q2 2024.
["Q2 2025 AUCATZYL® net product revenue reached $20.9 million", "Coverage secured for over 90% of U.S. medical lives", "Strong cash position of $454.3 million", "Received EU and UK conditional marketing authorizations", "Promising 42.5-month median duration of response in FELIX trial", "46 fully activated centers in U.S.", "Net loss decreased to $47.9M from $58.3M year-over-year"]Autolus Therapeutics (Nasdaq: AUTL), a biopharmaceutical company focused on next-generation programmed T cell therapies, has scheduled its second quarter 2025 financial results announcement for August 12, 2025, before U.S. markets open.
The company will host a conference call and webcast at 8:30 AM EDT/1:30 PM BST featuring management's discussion of financial results and a business update. Participants must pre-register to receive dial-in details and a personal PIN for the call. A simultaneous audio webcast and replay will be available on the company's website events section.
Autolus Therapeutics (Nasdaq: AUTL) has received European Commission (EC) marketing authorization for AUCATZYL® (obecabtagene autoleucel) to treat adult patients aged 26 and older with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
The approval is based on the FELIX clinical trial results, where the therapy demonstrated a 76.6% complete response rate in the pivotal cohort (n=94). The median response duration was 21.2 months, with median event-free survival of 11.9 months. Key safety data showed cytokine release syndrome in 68.5% of patients (2.4% grade 3+) and neurotoxicity in 22.8% of patients (7% grade 3+).
This EC authorization follows previous approvals from the FDA and MHRA, covering all 27 EU Member States, Iceland, Norway, and Liechtenstein. In Europe, approximately 6,000 new ALL cases are diagnosed annually, with up to 50% of adult B-ALL patients ultimately relapsing after frontline treatment.
Autolus Therapeutics (Nasdaq: AUTL), a biopharmaceutical company focused on programmed T cell therapies, has granted stock options to 60 employees under its 2025 Inducement Plan. The compensation committee approved options to purchase 360,550 shares at an exercise price of $2.47 per share, matching the July 9, 2025 closing price.
The options have a 10-year term with a four-year vesting schedule: 25% vests after one year, followed by monthly vesting over 36 months. These grants were made as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4).