Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®
Calliditas Therapeutics AB - American Depositary Shares (CALT)
Company Research
Source: PR Newswire
SHANGHAI, March 11, 2024 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.Following full approval in December 2023, Nefecon® 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 congratulate our partner for receiving seven more years of market exclusivity for Nefecon® i
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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