reports
Autolus Therapeutics to Report Second Quarter 2025 Financial Results a...
Autolus Therapeutics to Report Second Quarter 2025 Financial Results and Host Conference Call on August 12, 2025 LONDON and GAITHERSBURG, Md., July 24, 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 second quarter 2025 financial results and operational highlights before open of U.S. markets on Tuesday, August 12, 2025. Management will host a conference call and webcast at 8:30am EDT/13:30pm BS...
- Hilde Van Boxstael
- Livio Luyten
- Lynn Hautekeete
- Michiel Declercq
- Wim Hoste
- Michiel Declercq
Autolus Aucatzyl gains EC approval in r/r adult ALL
Autolus announced that the European Commission (EC) has granted marketing authorization for Aucatzyl (obe-cel, CD19 CAR-T) for the treatment of adults aged 26+ years with r/r B-ALL. Autolus will now evaluate market entry opportunities in the EU, which we expect to take place on a country-by-country basis – the company has previously indicated that the initial focus in the EU will be on Germany. More broadly, the US commercial launch in r/r adult ALL began in early 2025, and the first quarter of ...
Autolus Therapeutics’ CAR T Therapy AUCATZYL® (Obecabtagene Autoleucel...
Autolus Therapeutics’ CAR T Therapy AUCATZYL® (Obecabtagene Autoleucel) Granted European Marketing Authorization for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) Approval is based on FELIX clinical trial of obecabtagene autoleucel (obe-cel) in adult patients with r/r B-ALL, demonstrating high and durable response rates and low toxicityEC approval follows positive CHMP opinion, MHRA conditional marketing authorization and FDA approval LONDON and GAITHERSBURG, Md., July 21, 2025 (GLOBE NEWSWIRE) -- Autolus Therape...
Autolus Therapeutics Announces Inducement Grants Under Nasdaq Listing ...
Autolus Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) LONDON & GAITHERSBURG, Md., July 15, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, today announced that the compensation committee of the Company's Board of Directors granted stock option awards to purchase an aggregate of 360,550 shares of its common stock to 60 employees pursuant to the Company’s 2025 Inducement Plan. The stock opti...
- Jacob Mekhael
Autolus Longer follow up at EHA maintains Aucatzyl's benefit in r/r ad...
Autolus announced updated long term data (approx. 3 years of follow up) from the phase 2 (FELIX) study of Aucatzyl (CD19 CAR-T) in r/r adult ALL to be presented at the European Hematology Association (EHA) conference, being held 12-15 June. The updated results demonstrate that Aucatzyl has maintained its benefit without the need for additional therapy with an additional 11 months of follow up as 38.4% of responders are in ongoing remission (vs. 40% at 21.5 months median follow up). We believe th...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Vranken
- Wim Lewi
Autolus Therapeutics Presents Long-Term Follow Up from the FELIX Study...
Autolus Therapeutics Presents Long-Term Follow Up from the FELIX Study Demonstrating Obe-Cel's Potential for Long-Term Remission in R/R B-ALL at the 2025 European Hematology Association (EHA) Congress Median duration of response in FELIX study now 42.6 months after an additional 11 months of follow upMore than half of patients still in remission at 24 months38% of ongoing responders did not receive any subsequent therapy by month 33 Results suggest a proportion of patients with r/r B-ALL may not need further therapy following treatment with obe-cel LONDON, June 12, 2025 (GLOBE NEWSWIRE...
Autolus Therapeutics to Participate in Upcoming Investor Conferences
Autolus Therapeutics to Participate in Upcoming Investor Conferences LONDON, May 29, 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 upcoming investor conferences. William Blair 45th Annual Growth Stock ConferenceManagement to host investor meetingsDate: June 3, 2025Location: Chicago, IL Jefferies Global Healthcare ConferenceFireside Chat PresentationDate and time: June 5, 2025; 3:10pm E...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Autolus Receives positive CHMP opinion for Aucatzyl in r/r adult ALL i...
Friday during trading hours, Autolus announced the EMA's CHMP issued a positive opinion for Aucatzyl (CD19 CAR-T) in r/r adult ALL. The European Commission is expected to make a decision on marketing approval in the EU within approx. 2 months, and usually follows the CHMP opinion. Commercial launch in Europe is expected to be on a country by country basis, and the company has previously indicated that the initial focus in Europe will be on Germany and the UK. With initial US sales showing solid ...
Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene ...
Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) Positive CHMP opinion based on FELIX clinical trial of obecabtagene autoleucel (obe-cel) in adult patients with r/r B-ALL, demonstrating high and durable response rates and low toxicityOpinion follows FDA approval and MHRA conditional marketing authorisationEuropean Commission (EC) decision on conditional marketing authorization application (MAA) expected within approximately two months L...
- Jacob Mekhael
EHA abstracts Autolus, Galapagos, MaaT
The abstracts for presentations at EHA (12-15 June) 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 (long-term findings and predictors of sustained remission for Aucatzyl in r/r adult ALL, as well as age stratified outcomes), Galapagos (more data and follow up from its decentralised CAR-T program) and MaaT (additional data from ...
Autolus Therapeutics Presents Clinical Data Updates at the 2025 Europe...
Autolus Therapeutics Presents Clinical Data Updates at the 2025 European Hematology Association (EHA) Congress LONDON, May 14, 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 the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 12-15, 2025, Milan, Italy. Autolus will have two oral and one poster presentation, which includes updated follow up from the FELIX ...
- Jacob Mekhael
Autolus 1Q25 shows higher than expected Aucatzyl sales in r/r adult AL...
Yesterday before US market open, Autolus reported 1Q25 results with the highlight being the first Aucatzyl (CD19 CAR-T) sales in r/r adult ALL in the US ($ 9m), coming in above our expectations (1Q25 KBCSe $ 5m) and sending the stock up +10%. We see the stronger than expected initial demand as a good sign for the remainder of the launch. Seasonality remains to be seen, but if this momentum continues for the rest of FY25, our sales estimate of $ 43m will be within reach (BBG CSS $ 37m). We reiter...
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
- Thomas Vranken
- Wim Hoste
- Wim Lewi
Autolus Therapeutics Reports First Quarter 2025 Financial Results and ...
Autolus Therapeutics Reports First Quarter 2025 Financial Results and Business Updates Company reports Q1 2025 AUCATZYL® net product revenue of $9.0 millionU.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL® for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)Encouraging preliminary data reported in Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE); planned Phase 2 pivotal clinical trial in lupus nephritis (LN) and Phase 1 clinical trial in pr...
- 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 ...
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