Backed by the phase 2b/3 EPICS-III trial, saroglitazar demonstrated a significant 56.7% biochemical response rate compared with 9.8% for placebo, while showing favorable safety data.

The 3-month extension follows a major amendment to the NDA for the intrathecal cyclodextrin-based therapy, which has shown a 71% reduction in mortality risk in clinical trials.

The combination regimen significantly improved progression-free survival and objective response rates in patients who were intolerant to or failed prior imatinib therapy ...