Your email has been successfully added to our mailing list.

×
0.00141643059490082 0.00424929178470258 0.00424929178470258 0.0113314447592068 -0.00424929178470258 -0.0056657223796034 -0.0056657223796034 -0.0056657223796034
Stock impact report

Autolus secures FDA approval for CAR-T cell therapy use in ALL [Yahoo! Finance]

Autolus Therapeutics plc - American Depositary Shares (AUTL) 
Last autolus therapeutics plc - american depositary shares earnings: 11/7 07:06 am Check Earnings Report
US:NASDAQ Investor Relations: autolus.com/investor-relations
Company Research Source: Yahoo! Finance
receptor (CAR)-T cell therapy for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (B-ALL). The approval follows a heightened regulatory focus on CAR-T cell therapy safety this year. In April, the FDA mandated boxed warnings for these therapies due to rare cases of T cell malignancies. Aucatzyl's labelling includes these standard warnings for risks associated with cytokine release syndrome (CRS) and neurologic toxicities. The FDA's approval decision was based on data from the FELIX trial (NCT04404660), which evaluated the therapy in adult patients with relapsed or refractory B-ALL. In a subgroup of 65 patients with morphological disease and over 5% bone marrow blasts, Aucatzyl demonstrated a 63% overall complete remission (CR). The main efficacy outcome — CR within three months — was achieved in 42% of patients, with a median duration of remission of 14.1 months. Aucatzyl showed a relatively low incidence of severe adverse events in the F Show less Read more
Impact Snapshot
Event Time:
AUTL
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison Updated
Event Day
Stock performance from the time of news release until the following 4pm ET market close
Last price at news event
Since Event
Multi-day stock performance from the time of the news release
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST
PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
Last Price
VWAP
High:
Max Up
High:
Low:
Max Down
Low:
%
Post news range
%
Price change

Price Change Percentage


S&P 500
(SPX)

%

Volume ratio
%

Volume
Ticks

Avg transaction size

Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Opt-in for
AUTL alerts

from News Quantified
Opt-in for
AUTL alerts

from News Quantified