reports
- Jacob Mekhael
Autolus FIRST LOOK: 3Q24 update focusses on Aucatzyl's launch in r/r a...
Yesterday before US market opens, Autolus reported 3Q24 results with a cash position of $657.1m (YE23: $239.9m), sufficient to drive Aucatzyl's (obe-cel, CD19 CAR-T) launch in r/r adult ALL, and advance the company's pipeline towards pivotal autoimmune data (KBCSe 2028). The focus of the 3Q24 update was Aucatzyl's upcoming launch, and we expect the large safety differentiation vs. Tecartus to be a key factor for adoption. In parallel, we look forward to initial autoimmune data in 1Q25, which has...
- Jacob Mekhael
- Michiel Declercq
- Thibault Leneeuw
- Thomas Couvreur
- Wim Lewi
Autolus Therapeutics Reports Third Quarter 2024 Financial Results and ...
Autolus Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates AUCATZYL® (obecabtagene autoleucel) approved by US FDA on November 8, ahead of target PDUFA date of November 16; US commercial launch initiatedBLA approval triggers $30m milestone payment to Autolus from Blackstone Marketing authorizations for obe-cel under review with both the MHRA EMAMatthias Will M.D. appointed as Chief Development Officer, effective September 30, 2024Conference call to be held today at 08:30 am EDT/13:30 pm BST: conference call participants should pre-register using the link at the bo...
- Jacob Mekhael
Autolus Christmas came early! CAR-T hits the road with FDA approval in...
Our life sciences top pick Autolus secured FDA approval for Aucatzyl (obe-cel, CD19 CAR-T) in r/r adult B-ALL ahead of the scheduled PDUFA date of 16 November. In our view Aucatzyl has a best in class safety profile, and the absence of a requirement for a REMS program from the FDA provides further validation of its differentiated safety. Based on KOL feedback, Aucatzyl's safety profile will be a key driver for adoption, and we think no REMS will give this a further boost! We look forward to the ...
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene...
Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy)Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALLConference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOB...
- Jacob Mekhael
ASH abstracts Autolus, Galapagos, MaaT
The abstracts for presentations at ASH (7-10 December) became available yesterday during the day (here). While we may have to wait until the actual conference for the latest datasets, here in this note are some key takeaways for our coverage including updates from Autolus (digging deeper into the obe-cel dataset), Galapagos (more CAR-T data and pre-clinical data on TCR-T) and MaaT (early access program in aGvHD):
Autolus Therapeutics to Present Clinical Data Updates at the American ...
Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2024 in One Oral Presentation and Three Poster Presentations LONDON, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces the online publication of four abstracts submitted to the American Society of Hematology (ASH) Annual Meeting, to be held from December 7-10, 2024, in San Diego. “The FELIX study’s rich data set continues to provide importan...
Autolus Therapeutics to Report Third Quarter 2024 Financial Results an...
Autolus Therapeutics to Report Third Quarter 2024 Financial Results and Host Conference Call on November 12, 2024 LONDON, Oct. 28, 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 third quarter 2024 financial results and operational highlights before open of US markets on Tuesday, November 12, 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 g...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Wim Lewi
Autolus Therapeutics Presents Clinical Data Update at the 2024 Lymphom...
Autolus Therapeutics Presents Clinical Data Update at the 2024 Lymphoma, Leukemia & Myeloma Congress Findings suggest the potential for obe-cel treatment without the need for consolidative SCTObe-cel given as a sole treatment to patients with lower tumor burden at lymphodepletion was associated with better outcomes LONDON, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announces a poster presentation at the 2024 Lymphoma, Leukemia & Myeloma Congress being held ...
- Jacob Mekhael
- Michiel Declercq
- Thomas Vranken
Life Sciences Conference 26.09.2024
This conference booklet is your guide to our Life Sciences Conference set to take place on Thursday, 26 September 2024 at our historic building at Grand Place in Brussels. This event offers the possibility to have one-on-one meetings and/or join pitch sessions with the following companies and their top management: Public: AUTOLUS | GALAPAGOS | HYLORIS | INVENTIVA | MAAT PHARMA | ONWARD MEDICAL | SEQUANA MEDICAL | UCB | ZEALAND PHARMA Private: CONFO TX | MRM HEALTH | PANTERA | SKYLINE DX
Autolus Therapeutics announces appointment of Matthias Will, M.D. as C...
Autolus Therapeutics announces appointment of Matthias Will, M.D. as Chief Development Officer LONDON, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announced the appointment of Matthias Will, M.D., as Chief Development Officer. Dr. Will is joining Autolus’ executive team and will lead the company's development organization effective September 30, 2024. “Matthias has a proven track record of success in pharmaceutical product development, achieving many key ...
Autolus Therapeutics Presents Clinical Data Update at the Society of H...
Autolus Therapeutics Presents Clinical Data Update at the Society of Hematologic Oncology (SOHO) Annual Meeting 2024 Tumor Burden (TB)-guided dosing strategy, together with the unique fast off-rate binder of obe-cel, resulted in substantial response and low incidence of Grade ≥3 immunotoxicityTB-guided dosing of obe-cel in the FELIX Phase Ib/II study demonstrated high CAR T-cell expansionPeak expansion was reached after Dose 2 in both low and high TB groups, demonstrating the positive effect from both doses of obe-cel, irrespective of TB at lymphodepletion LONDON, Aug. 27, 2024 (GLOB...
- Jacob Mekhael
Autolus 2Q24 update holds no surprises, obe-cel r/r ALL PDUFA in 4Q24
Autolus reported 2Q24 results in line with expectations, with 2H24 set to be an eventful period for the company. We look forward to FDA decision on obe-cel (CD19 CAR-T) in r/r adult ALL in 4Q24 (PDUFA 16 November) and believe the odds of approval are solid based on the dataset to date. Beyond oncology, initial data from the phase 1 study of obe-cel in SLE will be one to watch, and if positive, could position obe-cel as a pipeline in a product. We reiterate our $11 TP and BUY rating. Autolus rema...
Autolus Therapeutics Reports Second Quarter 2024 Financial Results and...
Autolus Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates On track for potential US commercial launch of obe-cel; PDUFA date November 16, 2024Longer follow up and subset analyses from pivotal FELIX Phase 2 data presented at ASCO and EHA; majority of responders showed durable responses; 40% of patients in ongoing remission without subsequent stem cell transplant (SCT) or other intervention A Market Authorization Application (MAA) for obe-cel in relapsed/refractory r/r adult B-cell Acute Lymphoblastic Leukemia (B-ALL) was submitted to the Medicine and Healthcare ...
Autolus Therapeutics to Report Second Quarter 2024 Financial Results a...
Autolus Therapeutics to Report Second Quarter 2024 Financial Results and Host Conference Call on August 8, 2024 LONDON, July 26, 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 second quarter 2024 financial results and operational highlights before open of US markets on Thursday, August 8, 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 gene...
- Jacob Mekhael
Autolus FIRST LOOK: Presents additional obe-cel analysis in r/r ALL at...
Autolus presented additional analysis for obe-cel in r/r adult ALL at the European Hematology Association (EHA) congress, which included previously presented durability data for obe-cel showing that 40% of patients were in ongoing remission without subsequent therapies at 21.5 months follow up. The new presentations included i) the impact of inotuzumab (INO)-containing bridging therapy on treatment outcomes, and ii) droplet digital PCR and flow cytometry sensitivity for measuring CAR T-cell kine...
Autolus Therapeutics to Present Three Clinical Data Updates on obecabt...
Autolus Therapeutics to Present Three Clinical Data Updates on obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) B-Cell acute lymphoblastic leukemia (ALL) patients at the 2024 European Hematology Association (EHA) Congress LONDON, June 14, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces three abstracts to be presented at the European Hematology Association (EHA) Congress, June 13-16, 2024. “We are looking forward to presenting longer-term dat...
- Jacob Mekhael
- Thomas Vranken
- Jacob Mekhael
ASCO24 CAR-T round-up @ ASCO24
This year's CAR-T updates at ASCO24 mostly featured longer follow up and subgroup analyses from existing trials. Most noteworthy was the longer follow up from one of our life sciences top picks Autolus, which led to excitement in the room and an approx. 9% stock move. The company presented a 40% ongoing remission rate without subsequent therapy at median follow up of 21 months for obe-cel (CD19 CAR-T) in r/r adult ALL. On top of the well-established safety profile, we think this efficacy outcome...
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