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Autolus Therapeutics plc (AUTL) operates in the clinical-stage biopharmaceutical sector, where news catalysts often center on clinical trial data readouts, regulatory decisions, and development milestone achievements. For companies developing CAR T-cell therapies, investor attention focuses on patient enrollment updates, efficacy and safety results from ongoing studies, manufacturing progress, and regulatory interactions with health authorities.
This news feed tracks Autolus-specific developments across several categories relevant to cell therapy companies. Clinical data presentations at medical conferences provide insights into how the company's investigational therapies perform in patient populations, including response rates and safety profiles. Regulatory announcements such as health technology assessment recommendations, regulatory authority opinions, and approval decisions directly impact commercialization timelines and market access potential.
Corporate developments including executive appointments, partnership announcements, and capital market activities also appear in this feed. For clinical-stage biotechnology companies, personnel changes in key roles such as research leadership or commercial functions can signal strategic shifts, while financing activities provide visibility into the company's capital position and runway for funding ongoing development programs.
The news coverage includes quarterly financial reports that disclose clinical progress updates, cash positions, and operational developments. These reports often contain forward-looking guidance on trial timelines, regulatory submission plans, and manufacturing readiness. Patient dosing announcements and trial initiation updates provide visibility into the pace of clinical development across the company's pipeline.
Autolus (NASDAQ: AUTL) reported preliminary unaudited AUCATZYL® (obe-cel) net product revenue of approximately $24M for Q4 2025 and $75M for full-year 2025, and issued 2026 revenue guidance of $120M–$135M. Independent ROCCA real-world data confirmed strong clinical activity and a favorable safety profile. Key clinical updates include a 95.5% ORR in pediatric r/r B-ALL (CATULUS Phase 1) and selection of 50M cells as the Phase 2 dose in lupus nephritis (LUMINA). The company expects positive gross margin in 2026 and sufficient cash to fund operations into Q4 2027.
Autolus (NASDAQ: AUTL) will evaluate Cellares’ fully automated Cell Shuttle platform to complement commercial manufacturing of AUCATZYL® (obe-cel) at its Nucleus facility in Stevenage, UK.
The Cell Shuttle integrates CAR T unit operations in a single-use cartridge and can process up to 16 patient batches in parallel, with an architecture Cellares says can deliver up to 10-fold higher throughput versus conventional facilities. Cellares pairs this with Cell Q for automated, high-throughput QC and holds the FDA AMT designation.
Autolus (NASDAQ: AUTL) presented updated Phase 1 CARLYSLE data for obe-cel in severe refractory systemic lupus erythematosus (srSLE) at ASH on Dec 8, 2025.
Nine adults were infused (six at 50×10^6 cells, three at 100×10^6). At 50M, CRR 50% (3/6) and DORIS 83% (5/6) were reported with median DORIS onset 5.1 months and median follow-up 12 months. All patients showed deep B-cell depletion; median CAR T-cell persistence was 3.0 months and peak expansion at a median of 10 days. Safety: no DLTs at 50M, no ICANS, Grade 1 CRS in three patients at 50M and three at 100M; one transient Grade 3 liver toxicity in 100M cohort; hypertension observed in five patients at 50M.
50M chosen as recommended Phase 2 dose; LUMINA Phase 2 in lupus nephritis with registrational intent is now enrolling and aligned with FDA.
Autolus (NASDAQ: AUTL) presented clinical and real-world data on obecabtagene autoleucel (obe-cel) at ASH 2025 showing high remission rates and a favorable safety profile. In pediatric CATULUS data (n=21) the overall response rate was 95.5% with 90.9% CR, and high‑grade CRS and ICANS each occurred in 8.7% of patients; median follow-up was 8.8 months. FELIX post-hoc analyses found CAR T persistence at Month 3 (75.9%) associated with longer EFS and OS. Product cell phenotype (higher Tcm %) correlated with better outcomes. Real-world ROCCA data during the US launch mirrored low rates of high‑grade CRS and ICANS.
Autolus Therapeutics (Nasdaq: AUTL) announced the appointment of Ryan Richardson to its Board of Directors effective Dec 1, 2025.
Mr. Richardson brings more than 20 years of strategy and corporate development experience, including service as Chief Strategy Officer and management board member at BioNTech from Sept 2018 to Sept 2025. The company said his background in corporate development, capital markets, IPOs, financings and M&A will support Autolus' transition as a commercial-stage company and advance commercial launch and expansion efforts for obe-cel.
His prior roles include Executive Director at J.P. Morgan Global Healthcare Investment Banking (2011–2018) and chairmanship at Instadeep following BioNTech's 2023 acquisition.
Autolus Therapeutics (Nasdaq: AUTL) announced that NICE published draft guidance recommending AUCATZYL® (obecabtagene autoleucel) as a treatment option for adult patients aged ≥26 years with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (r/r B‑ALL).
AUCATZYL will be available through routine commissioning by the NHS in England and Wales and Autolus intends to launch imminently while pursuing Scottish access. The MHRA granted conditional marketing authorisation in April 2025, based on the FELIX study published in the New England Journal of Medicine in November 2024.
Autolus Therapeutics (Nasdaq: AUTL) will participate in the Jefferies Global Healthcare Conference in London. CEO Dr. Christian Itin will appear in a fireside chat on Tuesday, November 18, 2025 at 7:30 AM EST / 12:30 PM GMT. A live webcast will be available on the company’s Events page and a replay will be archived on the website for 90 days after the presentation.
The presentation covers company updates and investor engagement; webcast access is via the company investor relations site.
Autolus Therapeutics (Nasdaq: AUTL) reported Q3 2025 results and operational updates on Nov 12, 2025. Key commercial metrics: Q3 net product revenue $21.1M, deferred revenue $7.6M, and 60 U.S. treatment centers activated as of Nov 12, 2025. Cash and marketable securities totaled $367.4M at Sept 30, 2025.
Clinical highlights include rmAT designation for obe-cel in pediatric r/r B-ALL, CARLYSLE Phase 1 data in severe refractory SLE showing DORIS remission in 83% (5/6) and CRR in 50% (3/6), and first patient dosed in a progressive MS Phase 1 trial. Management additions announced to support commercialization and manufacturing.
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.
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