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 […]
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated […]
2023 was an exciting year for Optimum’s clients who overcame many of the market challenges to make significant strides forward with their vital life sciences research. Here are some of the highlights from what has been an exceptionally busy and successful year. M&A & deals Synaffix continued to build momentum – Lonza acquired the […]
Filing for full approval of TARPEYO FINANCIAL SUMMARY FOR THE GROUP Key Figures April 1 – June 30, 2023 Net sales amounted to SEK 269.4 million, of which TARPEYO® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted […]
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon® (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over […]
