FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder [Yahoo! Finance]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
Check Earnings Report
Company Research
Source: Yahoo! Finance
The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it plans to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval. If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be Applied Therapeutics' first commercial product. The company has also submitted a Marketing Authorization Application (MAA) for govorestat for Classic Galactosemia to the European Medicines Agency (EMA), which was validated in December 2023 and is under review by the EMA's Committee for Medicinal Products for Human Use. The company expects a decision by the EMA in the fourth quarter of 2024. Galactosemia is a rare genetic metabolic disease resulting in an inability to metabolize the simple
Show less
Read more
Impact Snapshot
Event Time:
APLT
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
APLT 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
APLT alerts
High impacting Applied Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
APLT
News
- Applied Therapeutics Reports First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Applied Therapeutics Reports First Quarter 2024 Financial ResultsGlobeNewswire
- Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare ConferenceGlobeNewswire
- Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer [Yahoo! Finance]Yahoo! Finance
- Applied Therapeutics Appoints Dale Hooks as Chief Commercial OfficerGlobeNewswire
APLT
Earnings
- 5/9/24 - Miss
APLT
Sec Filings
- 5/17/24 - Form 144
- 5/16/24 - Form 144
- 5/9/24 - Form 10-Q
- APLT's page on the SEC website