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Autolus Therapeutics plc (NASDAQ: AUTL) is a pioneering biopharmaceutical company dedicated to the development and commercialization of engineered T-cell immunotherapy products. These innovative therapies are designed to treat life-threatening cancers with remarkable efficacy. Autolus is at the forefront of biotechnology, focusing on both haematological and solid tumors using patient-specific T-cell therapies.
At the heart of Autolus' clinical-stage pipeline is obecabtagene autoleucel (obe-cel). Additional promising candidates include AUTO1/22, AUTO3, AUTO5, AUTO6, AUTO7, and AUTO8. These products represent the next generation of programmed T-cell therapies, offering new hope for cancer patients worldwide.
Autolus' strategic initiatives are equally impressive. The company has formed a strategic alliance with BioNTech SE, a key player in the biotech industry. This partnership is poised to enhance the development and reach of Autolus' therapies. Additionally, Autolus has successfully completed an underwritten offering, strengthening its financial foundation.
Recent financial results highlight the company's strong performance. For the full year ended December 31, 2023, Autolus reported unaudited financial results, including significant UK SME R&D Tax Credits. These credits amounted to $19.5 million and $24.6 million for the years ended December 31, 2023, and 2022, respectively, providing a substantial boost to their research and development efforts.
Looking ahead, Autolus has outlined key updates and anticipated milestones for obe-cel, along with financial results for the quarter ended March 31, 2024. These updates are critical for investors and stakeholders who are keen to track the company's progress and achievements.
In summary, Autolus Therapeutics plc is leading a transformative revolution in medicine, treating life-threatening diseases through cutting-edge T-cell therapies. The company's strategic partnerships, robust pipeline, and solid financials position it as a leader in the biopharmaceutical industry.
Autolus Therapeutics (AUTL) announced multiple presentations at the 2025 Tandem Meetings, showcasing new data for their AUCATZYL® therapy. The presentations include an updated health economic cost model comparing adverse events costs versus other CAR-T therapies, demonstrating reduced healthcare costs due to shorter duration and lower incidence of CRS and ICANS.
Key findings include: a risk-stratification model for hematotoxicity to identify patients likely to benefit from obe-cel treatment; economic advantages of obe-cel over brexu-cel due to lower Grade 3/4 adverse events; superior outcomes of obe-cel versus standard of care therapies in matched External Control Arm studies; and strong correlation between deep molecular remission and better clinical outcomes, with 84% of responders achieving MRD <10-6 leukemic cells.
Autolus Therapeutics (Nasdaq: AUTL) has provided significant business updates and an overview of its 2025 milestones. The company is actively progressing with the commercial launch of AUCATZYL® (obecabtagene autoleucel or 'obe-cel'), with 24 treatment centers fully authorized as of January 10th, 2025, and plans to reach 30 centers by the end of January 2025 and 60 by the end of the year.
Notably, the National Comprehensive Cancer Network® (NCCN) has included AUCATZYL® in its Clinical Practice Guidelines in Oncology for treating adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This endorsement follows FDA approval on November 8, 2024, and publication of the FELIX trial data in the New England Journal of Medicine.
Autolus plans to expand its clinical development program into autoimmune diseases, with initial data from the CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) expected in Q1 2025. The company will provide further updates at an R&D investor event on April 23, 2025, in New York City.
Marketing authorization submissions for obe-cel are under regulatory review in the European Union and the United Kingdom, with potential approvals expected in the second half of 2025. Other anticipated milestones include initial data from the PY01 trial in pediatric ALL and a Phase 1 SLE trial presentation at a medical conference in H2 2025.
Autolus Therapeutics (NASDAQ: AUTL) presented clinical data updates at ASH 2024, featuring one oral and three poster presentations about obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
The FELIX trial demonstrated that obe-cel treatment achieved deep molecular remission in 84% of responders, correlating with improved event-free survival and overall survival. The study showed that lower tumor burden at lymphodepletion yielded the best survival benefits.
Additional findings revealed that bridging therapies were effective with obe-cel, maintaining its expansion and persistence. The treatment showed low incidence of severe adverse events, potentially reducing healthcare resource utilization costs. A new CAR-HEMATOTOX risk score was identified as a useful tool for patient risk stratification.
Autolus Therapeutics published data from the FELIX study of obe-cel in The New England Journal of Medicine, showing promising results for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia treatment. The study demonstrated a 76.6% overall response rate in the pivotal cohort, with a median follow-up of 20.3 months. The treatment showed low immune-related toxicity, with Grade ≥3 CRS and ICANS observed in only 2.4% and 7.1% of patients respectively. The 12-month event-free survival rate was 49.5%. Obe-cel was recently approved by the FDA as AUCATZYL® and is under review by EU and UK regulators.
Autolus Therapeutics announces FDA approval of AUCATZYL® (obecabtagene autoleucel) for adult B-cell Acute Lymphoblastic Leukemia treatment, ahead of the target PDUFA date. The approval triggers a $30 million milestone payment from Blackstone. Q3 2024 financial results show cash position of $657.1 million, with operating expenses of $67.9 million and net loss of $82.1 million. Marketing authorizations are under review with MHRA and EMA. The company appointed Matthias Will as Chief Development Officer and expects initial data from SLE Phase 1 study in Q1 2025.
Autolus Therapeutics announces FDA approval of AUCATZYL® for treating adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The approval is based on the FELIX clinical trial, where 63% of evaluable patients achieved overall complete remission, with 42% achieving complete remission within 3 months. The median duration of remission was 14.1 months. Notably, AUCATZYL is the first CAR T therapy approved without requiring a REMS program, showing low levels of Cytokine Release Syndrome (3% Grade 3) and manageable ICANS (7% Grade ≥3). The therapy will be manufactured at Autolus' Nucleus facility in Stevenage, UK, with Cardinal Health handling U.S. distribution.
Autolus Therapeutics (AUTL) will present four abstracts at the ASH Annual Meeting 2024 in San Diego, featuring updates on obecabtagene autoleucel (obe-cel) for adult r/r B-ALL treatment. Key findings include: 84% of responders achieved MRD <10-6 leukemic cells, associated with better survival rates; bridging therapy with Inotuzumab ozogamicin (INO) effectively reduced disease burden; analysis of healthcare resource utilization for managing CRS and ICANS events; and correlation between CAR-HEMATOTOX scores and patient outcomes.
Autolus Therapeutics (Nasdaq: AUTL), a clinical-stage biopharmaceutical company focused on programmed T cell therapies, will release its third quarter 2024 financial results before US markets open on November 12, 2024. The company will host a conference call and webcast at 8:30 am EDT/1:30 pm BST, where management will discuss financial results and provide a business update. Participants must pre-register to receive dial-in details and a personal PIN for the call.
Autolus Therapeutics presented clinical data at the 2024 Lymphoma, Leukemia & Myeloma Congress, focusing on obecabtagene autoleucel (obe-cel) for relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). Key findings suggest:
1. Comparable outcomes for patients regardless of stem cell transplant (SCT) timing pre or post obe-cel, indicating no additional benefit from consolidative transplant.
2. Better outcomes when obe-cel was given as sole treatment to patients with lower tumor burden at lymphodepletion.
3. 78% of obe-cel infused patients achieved CR/CRi.
4. At median 21.5 months follow-up, 49% of responders without SCT were alive and in remission, compared to 28% of those who underwent SCT.
5. Lower tumor burden at lymphodepletion was associated with improved event-free survival in patients without SCT.
These results suggest potential for obe-cel treatment without consolidative SCT in a large subgroup of patients and highlight the importance of reducing tumor burden prior to lymphodepletion for improved outcomes.
Autolus Therapeutics plc (Nasdaq: AUTL) has appointed Dr. Matthias Will as Chief Development Officer, effective September 30, 2024. Dr. Will, joining from Dren Bio, Inc., brings extensive experience in pharmaceutical product development and regulatory milestones. CEO Dr. Christian Itin highlighted Dr. Will's track record and leadership skills as valuable assets for expanding the obe-cel opportunity in oncology and autoimmune diseases.
Dr. Will expressed excitement about joining Autolus as it prepares to commercialize obe-cel for relapsed/refractory adult B-ALL. His previous roles include leadership positions at CRISPR Therapeutics, CytomX Therapeutics, Gilead Sciences, and Novartis Oncology. Dr. Will's appointment aims to strengthen Autolus' development organization and advance its innovative portfolio in oncology.
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