Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
Orchard Therapeutics plc - American Depositary Shares (ORTX)
Last orchard therapeutics plc - american depositary shares earnings: 2/27 07:00 am
Check Earnings Report
Company Research
Source: GlobeNewswire
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and cognitive development BOSTON and LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of March 18, 2024. “Today is another significant step forward for patients and families in the U.S. impacted by this devastating and cruel disease who for too long have dealt with the unimaginable burden of going through the diagnostic odyssey, being told there were no treatments beyond supportive care, and then having to wat
Show less
Read more
Impact Snapshot
Event Time:
ORTX
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
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
ORTX alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
ORTX alerts
High impacting Orchard Therapeutics plc - American Depositary Shares news events
Weekly update
A roundup of the hottest topics
ORTX
News
- Oxford Biomedica Plc - INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2023GlobeNewswire
- Orchard Therapeutics stock jumps 13% as FDA accepts BLA for OTL-200 [Seeking Alpha]Seeking Alpha
- FONDAZIONE TELETHON AND ORCHARD THERAPEUTICS COMPLETE TRANSFER OF MARKETING AUTHORIZATION OF STRIMVELIS FOR ADA-SCID IN EUROPEPR Newswire
- FONDAZIONE TELETHON AND ORCHARD THERAPEUTICS COMPLETE TRANSFER OF MARKETING AUTHORIZATION OF STRIMVELIS FOR ADA-SCID IN EUROPEPR Newswire
- Orchard Therapeutics Announces Presentation of Data Comprising the Clinical Package for the OTL-200 BLA in MLD at the SSIEM Annual Symposium 2023 [Yahoo! Finance]Yahoo! Finance
ORTX
Sec Filings
- 9/18/23 - Form 8-K
- 8/22/23 - Form EFFECT
- 8/21/23 - Form 424B3
- ORTX's page on the SEC website