Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®
Calliditas Therapeutics AB - American Depositary Shares (CALT)
Company Research
Source: PR Newswire
STOCKHOLM, March 6, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, TARPEYO® (budesonide) is indicated 'to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression'. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN."We are delighted to have seven years of market exclusivity expiring in December 2030 for TARPEYO in the US, reflecting the new indication based on the long-term data genera
Show less
Read more
Impact Snapshot
Event Time:
CALT
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
CALT 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
CALT alerts
High impacting Calliditas Therapeutics AB - American Depositary Shares news events
Weekly update
A roundup of the hottest topics
CALT
News
- Calliditas Therapeutics' 2023 Annual Report PublishedPR Newswire
- Calliditas Therapeutics' 2023 Annual Report Published [Yahoo! Finance]Yahoo! Finance
- Calliditas Therapeutics' 2023 Annual Report PublishedPR Newswire
- Calliditas Announces Positive NefIgArd Open Label Extension Results [Yahoo! Finance]Yahoo! Finance
- Calliditas Announces Positive NefIgArd Open Label Extension ResultsPR Newswire
CALT
Analyst Actions
- 2/22/24 - HC Wainwright
CALT
Sec Filings
- 4/25/24 - Form 6-K
- 4/24/24 - Form 20-F
- 3/6/24 - Form 6-K
- CALT's page on the SEC website