reports
Abstract for longer-term follow-up and additional data analysis of Piv...
Abstract for longer-term follow-up and additional data analysis of Pivotal Phase 2 FELIX study of obe-cel for adult r/r B-ALL selected for an oral presentation at ASCO LONDON, April 24, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the abstract for longer-term follow-up and additional data analysis from the pivotal Phase 2 FELIX study of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) was ...
Autolus Therapeutics to Report First Quarter 2024 Financial Results an...
Autolus Therapeutics to Report First Quarter 2024 Financial Results and Host Conference Call on May 14, 2024 LONDON, April 23, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced that it will release its first quarter 2024 financial results and operational highlights before open of US markets on Tuesday, May 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the company’s financial results and provide a general bu...
- Jacob Mekhael
- Thomas Vranken
Autolus FIRST LOOK: European dossier acceptance for obe-cel
The EMA has accepted the marketing authorisation application for review of obe-cel for r/r B-ALL, following the earlier acceptance by the FDA in January 2024. Looking ahead, Autolus is set for an eventful year with the FDA decision on obe-cel (PDUFA 16 November), as well as multiple data readouts including initial data from the phase 1 SLE trial by YE24, which we think could position obe-cel to become a pipeline in a product. We reiterate our BUY rating and $11 TP.
Autolus Therapeutics announces acceptance of Marketing Authorization A...
Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obecabtagene autoleucel (obe-cel) for Patients with Relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (B-ALL) Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALLThe US marketing application is under review with a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024 LONDON, April 02, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceu...
Autolus Therapeutics Announces Changes to its Board of Directors
Autolus Therapeutics Announces Changes to its Board of Directors LONDON, April 01, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director. John H. Johnson advised the Board of his decision to step down from his role as Chairman of the Board and Non-Executive Director. These changes are effective as of today, April 1, 2024. “On behalf of the Board and Managemen...
- Jacob Mekhael
Autolus FIRST LOOK: Uneventful FY23 results, obe-cel's PDUFA in r/r AL...
Autolus reported uneventful FY23 results, with approx. $ 240m in cash (plus $ 600m from the strategic collaboration with BioNTech and public equity raise in February 2024) – enough to fully support the commercialisation of obe-cel in r/r adult ALL, as well as support obe-cel's pipeline expansion towards pivotal data in autoimmunity. Looking ahead, Autolus is set for an eventful year with an FDA decision on obe-cel in r/r adult ALL (PDUFA 16 November), as well as multiple data readouts including ...
Autolus Therapeutics Reports Full Year 2023 Financial Results and Busi...
Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates Announced strategic collaboration and equity investment from BioNTech for aggregate proceeds of $250 million upfront, plus underwritten offering of ADSs for $350 million, for gross proceeds of $600 million received in February 2024Submitted a Biologics License Application (BLA) for obecabtagene autoleucel (obe-cel), a potentially transformational treatment for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), to the US Food & Drug Administration (FDA); Prescription Drug User Fee Act (...
- Jacob Mekhael
- Thomas Vranken
Autolus FIRST LOOK: MHRA certification for manufacturing site
Autolus' manufacturing site, the Nucleus, has obtained MIA and GMP certification from the MHRA, enabling production of global commercial and clinical product supply. We estimate the site to have a capacity of 2,000+ batches per year, sufficient to cover the company's launch in r/r ALL and beyond, while targeting a vein-to-delivery time of 16 days at launch. With ample capacity at launch, we do not expect Autolus to run into the manufacturing or supply issues experienced by other companies during...
Autolus Therapeutics receives Medicines and Healthcare products Regula...
Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site LONDON, March 12, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus’ Nucleus manufacturing facility in Stevenage has obtained a Manufacturer’s Importation Authorisation (MIA) together with the accompanying GMP certificate. This authori...
Autolus Therapeutics announces publication in Blood Cancer Journal
Autolus Therapeutics announces publication in Blood Cancer Journal 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 Mayo Clin...
Autolus Therapeutics to Report Full Year 2023 Financial Results and Bu...
Autolus Therapeutics to Report Full Year 2023 Financial Results and Business Updates on March 14, 2024 LONDON, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that it will release its fourth quarter and full year 2023 results and operational highlights on Thursday March 14, 2024. Management will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT to discuss the company’s financial results and provide a general business update. Conference...
Autolus Therapeutics announces publication in Nature Communications
Autolus Therapeutics announces publication in Nature Communications LONDON, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces a publication in Nature Communications entitled: ‘Structure-Guided Engineering of Immunotherapies Targeting TRBC1 and TRBC2 in T Cell Malignancies.’1 In contrast to B cell lymphomas, T cell lymphomas have not benefited from immunotherapies such as therapeutic antibodies or CAR T cell therapies. This is because suitable surf...
- Jacob Mekhael
Autolus Gains $600m through BioNTech deal and equity raise to develop ...
Autolus announced a strategic collaboration with BioNTech, which involves an equity investment of $200m ($6 per ADS), and a license and option agreement for a $50m cash up front. In addition, the company raised $350m via a public offering of 58m shares at a price of $6 per ADS (approx. 5% discount to previous close). While management did not provide concrete guidance on cash runway, Autolus has gained a significant amount of resources with a total of $600m in additional cash. This will enable th...
Autolus Announces Pricing of Underwritten Offering
Autolus Announces Pricing of Underwritten Offering 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 the net proceeds from this off...
BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaborati...
BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs 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 authorizationBioNTech 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+ tumorsBioNTech to support launch and expansion of development program of Autolus’ lead cell therapy...
- Maria Vara
- Oscar Haffen Lamm
End of coverage
From 5th February, we will no longer include in our research universe:Adaptimmune, ALK, argenx, Autolus, Cellectis, Galapagos, Hansa Biopharma, Heidelberg Pharma, Immatics, Immunocore, Ipsen, Moonlake Immunotherapeutics, Pharvaris, UCB, Vivoryon Therapeutics, Zealand Pharma, Nicox, GenSight Biologi
CLLS CELLECTIS ADS
ADAP ADAPTIMMUNE THERAPEUTICS ADS
ANZ AUSTRALIA AND NEW ZEALAND BANKING GROUP LIMITED
HPHA HEIDELBERG PHARMA AG
COX NICOX SA
UCB UCB S.A.
HNSA HANSA BIOPHARMA AB
SIGHT GENSIGHT BIOLOGICS SA
ALSEN SENSORION SAS
ALKb ALK-ABELLO
ARGX ARGEN-X SE
AUTL AUTOLUS THERAPEUTICS ADS
IMCR IMMUNOCORE HOLDINGS ADS
PHVS PHARVARIS NV
MLTX MOONLAKE IMMUNOTHERAPEUTICS
IMTX IMMATICS
GLG GALAPAGOS
VVY VIVORYON THERAPEUTICS
- Jacob Mekhael
Autolus Initiation: Setting the benchmark for auto CAR-Ts
Autolus is a UK biotech developing next gen CAR-Ts in oncology and autoimmunity. Lead candidate obe-cel (CD19 CAR-T) has demonstrated a best in class profile on safety and durability in r/r adult ALL and FDA approval is expected in 4Q24, while potential expansion into autoimmune indications could make obe-cel a pipeline in a product. Beyond obe-cel, next gen CAR-Ts in MM, PTCL and paediatric ALL have shown early but solid data, and more follow up in 2024 could serve as validation for those candi...
Autolus Therapeutics announces publication in ACS Chemical Biology
Autolus Therapeutics announces publication in ACS Chemical Biology 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, cell therapies h...
Autolus Therapeutics announces acceptance of Biologics License Applica...
Autolus Therapeutics announces acceptance of Biologics License Application for obecabtagene autoleucel (obe-cel) as a potential treatment for relapsed/refractory Adult B-cell Acute Lymphoblastic Leukemia (ALL) 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 a...
Autolus Therapeutics announces the appointment of Robert W. Azelby to ...
Autolus Therapeutics announces the appointment of Robert W. Azelby to its Board of Directors LONDON, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced the appointment of Robert W. Azelby to the Board of Directors. Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’s Board. “The Autolus Board and Management Team would like to welcome Bob Azelby to the Board of Directors. Bob brings with him a weal...
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