Calliditas Therapeutics: NDA Filing – Check
Research Note
2021-03-15
09:43
Redeye is undoubtedly positive about the New Drug Application (NDA) submission to the FDA for Nefecon in patients with IgA Nephropathy. While the filing was an expected event, it nevertheless relieves some timeline risk and should help boost investor sentiment, we judge. Calliditas has applied for accelerated approval, and the FDA will now have up to 60 days to accept the NDA submission and to decide whether Nefecon will receive a priority review. If a priority review is granted, we believe that an accelerated approval could occur in November (2+6 months from now). We reiterate our Base case of SEK 280 per share.
LS
Ludvig Svensson
Disclosures and disclaimers