Calliditas Therapeutics(US:CALT)2024-05-23 16:51TARPEYO/Kinpeygo Commercial Performance - Q1 2024 saw record enrolments, a 27% increase over Q4, following a 51% increase over Q3[5] - Q1 2024 net sales of TARPEYO were $26.8 million[5, 24] - Preliminary net sales of TARPEYO in Q2 2024 to date are approximately $25.5 million[5, 26] - Total revenue guidance for 2024 remains unchanged at $150 - $180 million[42] - Q1 2024 total revenues were SEK 295.5 million compared to SEK 191.4 million in Q1 2023[34, 39] representing a growth of 50%[39] Setanaxib Clinical Data - Phase 2 data for Setanaxib in Head and Neck cancer showed statistically significant improvements in Progression-Free Survival (PFS) and Overall Survival (OS)[6, 17, 18] - At 6 months, OS was 92% in the Setanaxib group versus 68% in the placebo group, and at 9 months, OS was 88% versus 58% respectively (Hazard ratio=0.45)[17] - Median PFS was 5 months in the Setanaxib group versus 2.9 months in the placebo group (Hazard ratio=0.58)[20] Other Key Updates - A new patent was issued covering TARPEYO, with product protection expiring in 2043[4] - TARPEYO received seven years of orphan protection from the FDA, expiring in December 2030[4] - Commercial launch in China took place in mid-May[5, 6]