Travere Therapeutics

FDA grants full approval to FILSPARI (sparsentan) for IgA nephropathy (IgAN), based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI is an oral, non-immunosuppressive, once-daily treatment targeting glomerular injury, with a durable benefit on proteinuria and kidney function over two years.

The FDA granted full approval to Travere Therapeutics’ sparsentan (Filspari) for proteinuria reduction in adults with IgA nephropathy (IgAN) at risk of rapid disease progression, based on 2-year results from the phase 3 PROTECT study. This makes sparsentan the second therapeutic to receive full approval for IgAN, following Calliditas Therapeutics’ budesonide. The PROTECT study demonstrated long-term kidney function preservation with sparsentan, showing a clinically meaningful difference in eGFR slope versus irbesartan.

FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.

FDA grants full approval to FILSPARI for IgA nephropathy, based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI, an oral, non-immunosuppressive treatment, targets glomerular injury and reduces proteinuria, positioning it as foundational care for IgAN.

Travere Therapeutics announces FDA full approval of Filspari (sparsentan) to slow kidney function decline in IgA nephropathy, based on PROTECT Study results showing significant benefit over irbesartan.

Phase III trials for Aravive’s batiraxcept in ovarian cancer and Travere’s Filspari in FSGS failed, reducing their LoA. VYNE’s VYN201 showed positive Phase Ib results in vitiligo. Moderna’s MEDI1191, Drug Farm’s DF-006, and Alexion’s ALXN-2220 completed Phase I trials, increasing their PTSR in solid tumors, hepatitis B, and ATTR-CM, respectively.

Travere Therapeutics' drug Filspari, for IgA nephropathy, showed slower kidney function decline over 24 months compared to irbesartan but narrowly missed statistical significance (P=0.058).

Biocom California announced new board members including Enoch Kariuki, Bernard Parker, Eric Dube, and Sabrina Martucci Johnson, alongside Natalie Hosea joining the board of governors. These additions aim to strengthen the organization's leadership in the life science industry, reflecting California's significant contributions and ensuring Biocom's continued support for its members.