Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…

ByRidhi RastogiNovember 26, 2025

Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)

Shots: The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026) sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind…

ByRidhi RastogiMay 16, 2025

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

Shots: Dimerix has granted Amicus exclusive US rights to develop & market DMX-200 for all indications, incl. focal segmental glomerulosclerosis (FSGS), with Amicus handling regulatory filings, dossier maintenance, & marketing in the US Dimerix will get $30M cash upfront, ~$75M on FDA approval, $35M on 1st sale, ~$40M for future indications & ~$410M in sales…

ByRidhi RastogiMay 1, 2025

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Travere Therapeutics Reports the US FDA’s sNDA Acceptance of Filspari for Focal Segmental Glomerulosclerosis (FSGS)

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

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