Welcome to our dedicated page for Autolus Therapeutics news (Ticker: AUTL), a resource for investors and traders seeking the latest updates and insights on Autolus Therapeutics stock.
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 Therapeutics (NASDAQ: AUTL) has received conditional marketing authorization from the UK MHRA for AUCATZYL® (obecabtagene autoleucel) to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).
The authorization is based on the FELIX study results, where 127 patients received the treatment. Key findings include:
- 76.6% Complete Response rate in the pivotal cohort
- 21.2 months median response duration
- 11.9 months median event-free survival
- 65.4% and 49.5% event-free survival rates at 6 and 12 months respectively
Safety data showed cytokine release syndrome in 68.5% of patients (2.4% grade 3 or higher) and immune effector cell-associated neurotoxicity in 22.8% of patients (7% grade 3 or higher). The company is currently working with NICE for potential NHS access in England.
Autolus Therapeutics (Nasdaq: AUTL) presented updates on its development pipeline and expansion plans in autoimmune diseases at an R&D investor event. The company highlighted the potential of obe-cel across multiple B cell driven malignancies and autoimmune diseases.
Key developments include:
- Preliminary data from Phase 1 CARLYSLE trial in six SLE patients showed promising results, with three patients achieving complete renal response by month three
- Plans to initiate Phase 2 pivotal study in lupus nephritis by year-end 2025
- Expansion into progressive multiple sclerosis (MS) with first patient dosing in Phase 1 trial expected by year-end 2025
- AUCATZYL US launch progressing with 38 centers fully activated
- Regulatory reviews ongoing in EU and UK, with MHRA decision expected in Q2 2025 and EMA in H2 2025
Autolus Therapeutics (Nasdaq: AUTL), an early commercial stage biopharmaceutical company focused on programmed T cell therapies, has scheduled its Q1 2025 financial results announcement for May 8, 2025, before US markets open. The company will host a conference call and webcast at 8:30 am EDT/13:30 pm BST to discuss financial performance and provide a business update. Participants must pre-register to receive dial-in details and a personal PIN for the conference call. A simultaneous audio webcast and replay will be available on the company's website events section.
Innate Pharma (Nasdaq: IPHA) has announced plans to transform its corporate governance structure, proposing to shift from an executive board/supervisory board model to a CEO/board of directors structure at its Annual General Meeting on May 22, 2025.
Under the proposed changes, Irina Staatz-Granzer, current Supervisory board Chairwoman, would become Chairwoman of the board of Directors, while Jonathan Dickinson, current Executive board Chairman, would be appointed CEO. The new board would include eight members, with two new additions: Christian Itin, CEO of Autolus, and Marty J. Duvall, a veteran biotech executive.
Three current board members, including co-founder Hervé Brailly, Gilles Brisson, and Jean-Yves Blay, will not join the new board. This transformation aims to simplify governance and align with international standards, reflecting the company's response to investor feedback.
Autolus Therapeutics (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company focused on programmed T cell therapies, has announced its participation in the 24th Annual Needham Virtual Healthcare Conference.
The company's CEO, Dr. Christian Itin, will engage in a Fireside Chat scheduled for Wednesday, April 9, 2025, at 9:30am EDT / 14:30pm BST. The presentation will be accessible via webcast on the company's website under the 'Events' page in the 'Investor Relations & Media' section. Interested parties can access the replay for 90 days following the presentation.
Autolus Therapeutics (Nasdaq: AUTL) has announced an upcoming R&D Investor Event scheduled for Wednesday, April 23, 2025, at 8:30am EDT / 13:30pm BST in New York City. The event will feature key updates on:
- Clinical pipeline programs and expansion plans for obe-cel
- Initial data from six patients in the CARLYSLE Phase 1 trial for systemic lupus erythematosus (SLE)
- Development plans for expansion in autoimmune diseases
- Progress update on the commercial launch of AUCATZYL®
The presentation will be accessible via webcast on the company's website, with a 90-day replay period available. Interested parties can inquire about in-person attendance through the provided contact.
Autolus Therapeutics (Nasdaq: AUTL) reported its Q4 and full year 2024 results, highlighting the successful US commercial launch of AUCATZYL® following FDA approval on November 8, 2024. The company has authorized 33 treatment centers as of March 19, 2025, covering approximately 60% of target US patients, with over 85% of US medical lives securing coverage.
Financial highlights include cash position of $588.0 million as of December 31, 2024, up from $239.6 million in 2023. The company reported a net loss of $220.7 million for 2024, with loss per share of $(0.86). Operating expenses increased with R&D at $138.4 million and SG&A at $101.1 million.
Key developments include MHRA and EMA marketing authorization decisions expected in H2 2025, initial dosing of six patients in Phase 1 SLE trial, and the company's manufacturing facility now FDA and MHRA licensed for commercial supply with 2,000+ batch capacity per year.
Autolus Therapeutics (Nasdaq: AUTL), an early commercial stage biopharmaceutical company focused on programmed T cell therapies, has scheduled its Q4 and full year 2024 financial results announcement for March 20, 2025, before US markets open.
The company will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT where management will present financial results and provide a business update. Participants must pre-register to receive dial-in numbers and a personal PIN for the conference call. A simultaneous audio webcast and replay will be available on the company's website events section.
Autolus Therapeutics (Nasdaq: AUTL), a commercial-stage biopharmaceutical company focused on programmed T cell therapies, has announced its participation in two upcoming investor conferences in Miami, FL.
The company will attend the Jefferies Biotech on the Beach Summit on March 11, 2025, where management will host investor meetings. Additionally, CEO Dr. Christian Itin will deliver a fireside chat presentation at the Leerink Global Biopharma Conference on March 12, 2025, at 8:40am EDT / 12:40pm GMT.
A webcast of the fireside chat will be accessible through the company's website's 'Events' page, with a replay available for 90 days post-presentation.