reports
- Jacob Mekhael
Autolus Aucatzyl secures UK MHRA approval in r/r adult ALL, all eyes o...
Last Friday evening, Autolus announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for Aucatzyl (CD19 CAR-T) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), in line with the expected timeline. Looking ahead, Autolus will report its 1Q25 results on 8 May, where the first quarter US sales of Aucatzyl will be reported and will give us a quantitative view on the launch momentum – note that ...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
Autolus Therapeutics Announces License of AUCATZYL® (obecabtagene auto...
Autolus Therapeutics Announces License of AUCATZYL® (obecabtagene autoleucel) Issued by UK MHRA for Adult Patients (≥ 18 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)(1) UK Medicines and Healthcare products Regulatory Agency (MHRA) authorisation based on FELIX clinical trial of obecabtagene autoleucel in adult patients with r/r B-ALL1AUCATZYL® licensed from MHRA under ‘conditional marketing authorisation’, meaning that the MHRA will review new efficacy and safety information at least once every year1 Investors, US and UK National, Medical and ...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Livio Luyten
- Michiel Declercq
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
Autolus R&D day outlines SLE data and path to market, MS up next
Yesterday, Autolus hosted an R&D day where it shared initial data from the phase 1 trial of obe-cel (CD19 CAR-T) in r/r SLE which showed that 3/6 patients achieved complete renal response (CRR). The company has aligned with the FDA on the route to market, and plans to initiate a pivotal phase 2 trial by YE25. In addition, Autolus announced its plan to evaluate obe-cel in progressive MS with a dose escalation trial due to begin by YE25. We reiterate our $ 10 TP and Buy rating.
Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D I...
Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D Investor Event Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advance...
Autolus Therapeutics to Report First Quarter 2025 Financial Results an...
Autolus Therapeutics to Report First Quarter 2025 Financial Results and Host Conference Call on May 8, 2025 LONDON, April 22, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces that it will release its first quarter 2025 financial results and operational highlights before open of US markets on Thursday, May 8, 2025. Management will host a conference call and webcast at 8:30 am EDT/13:30 pm BST to discuss the company’s fin...
- Guy Sips
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
US Tariffs Navigating the impact on Benelux equities
Trumps reciprocal tariffs caused a massive blow to equity markets, following a pressured period of escalating trade wars. Retaliatory measures can further heavily damage market confidence, as seen Friday when China announced their 34% tarrif of US goods. International trade policies have never moved this erratic and untransparant, with uncertainty and volatility being the baseline for now. In this report we highlight the key stocks in our coverage relevant to this discussion.
EURN EURONAV NV
ABN ABN AMRO BANK NV DEPOSITARY RECEIPTS
FAGR FAGRON SA
EVS EVS BROADCAST EQUIPMENT SA
XIOR XIOR STUDENT HOUSING N.V.
SOLB SOLVAY SA
UCB UCB S.A.
COFB COFINIMMO SA
DIE D'IETEREN SA
AGFB AGFA-GEVAERT NV
IBAB ION BEAM APPLICATIONS SA
AALB AALBERTS N.V.
ONTEX ONTEX GROUP N.V.
MELE MELEXIS NV
CSM CORBION NV
ABI ANHEUSER-BUSCH INBEV SA/NV
EXO EXOR N.V.
ASML ASML HOLDING NV
ARGX ARGEN-X SE
BESI BE SEMICONDUCTOR INDUSTRIES N.V.
ADYEN ADYEN NV
AUTL AUTOLUS THERAPEUTICS ADS
BAR BARCO NV
DEME DEME GROUP NV
FLOW FLOW TRADERS LTD
SYENS SYENSQO
Autolus Therapeutics to Participate in the 24th Annual Needham Virtual...
Autolus Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference LONDON, April 02, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the 24th Annual Needham Virtual Healthcare Conference. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Wednesday, April 9, 2025 at 9:30am EDT / 14:30pm BST. A webcast of the fireside chat will ...
Autolus Therapeutics to Host R&D Investor Event on Wednesday, April 23...
Autolus Therapeutics to Host R&D Investor Event on Wednesday, April 23, 2025 LONDON, April 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announced that the Company will host an R&D investor event on Wednesday, April 23, 2025 at 8:30am EDT / 13:30pm BST. Autolus will present an update on clinical pipeline programs, including plans to expand the obe-cel opportunity. The Company expects to report initial data in six patients from...
- Jacob Mekhael
Autolus FIRST LOOK: FY24 results hold no surprises, upcoming R&D day
Yesterday before US market opens, Autolus reported unsurprising FY24 results with a cash position of $ 588m (YE23: $ 239.6m), 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. While the company did not share sales figures/patients dosed with Aucatzyl in the US (1Q25 sales figures to be communicated during the quarterly update), management confirmed that the launch is tracking well compared to their ex...
- Hilde Van Boxstael
- Jacob Mekhael
- Sharad Kumar S.P
- Thomas Couvreur
- Wim Lewi
Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financi...
Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch progressing on track with 33 authorized treatment centers as of March 19, 2025, following US FDA approval on November 8, 2024Obe-cel MHRA and EMA marketing authorizations expected in H2 2025Initial six patients dosed in Phase 1 dose confirmation trial in Systemic Lupus Erythematosus (SLE) Company to provide clinical development program updates, including plans for expansion in autoimmune diseases, at R&D investor event to be held on...
Autolus Therapeutics to Report Fourth Quarter 2024 Financial Results a...
Autolus Therapeutics to Report Fourth Quarter 2024 Financial Results and Host Conference Call on March 20, 2025 LONDON, March 06, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced that it will release its fourth quarter and full year 2024 financial results and operational highlights before open of US markets on Thursday, March 20, 2025. Management will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT to dis...
Autolus Therapeutics to Participate in Upcoming Investor Conferences
Autolus Therapeutics to Participate in Upcoming Investor Conferences LONDON, March 05, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in two upcoming investor conferences. Jefferies Biotech on the Beach SummitManagement to host investor meetingsDate: March 11, 2025Location: Miami, FL Leerink Global Biopharma ConferenceFireside Chat PresentationDate and time: March 12, 2025; 8:40am EDT / 12:40pm G...
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Autolus PREVIEW: Aucatzyl US launch in r/r ALL could re-rate stock
Autolus' lead CAR-T Aucatzyl secured FDA approval in r/r adult ALL in 4Q24, and its differentiated safety profile vs. Tecartus is viewed favourably by KOLs. While the company is not planning to announce the first sale, we learned from management that they have product in production as we speak. We preview Aucatzyl's US launch and point out that reliable production will be key to secure prescriber confidence and sales, and view Autolus as well prepared to execute on that front. We lay out multipl...
Autolus Therapeutics Presents Clinical Data Updates at the 2025 Tandem...
Autolus Therapeutics Presents Clinical Data Updates at the 2025 Tandem Meetings LONDON, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces an oral presentation and three poster presentations accepted to the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held from February 12-15, 2025, in Hawai'i Convention Center, Honolulu, HI. “Building on our data presented at ASH in December, ...
- Guy Sips
- Jacob Mekhael
- Michiel Declercq
- Sharad Kumar S.P
- Thomas Vranken
- Jacob Mekhael
Autolus Aucatzyl US launch on track, upcoming R&D day to focus on grow...
Yesterday before US market opens, Autolus provided a business update and an overview of 2025 milestones, where the US commercial launch of Aucatzyl in r/r ALL is progressing in line with previously guided timelines. With 24 centres already authorised (targeting 30 by end Jan'25), the first commercial sales of Aucatzyl could come anytime now. We believe initial positive experience with the product will be key to drive adoption in FY25, and Autolus' manufacturing process has been stress tested to ...
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