Omeros Corp.’s phase III stumble in the busy immunoglobulin A nephropathy (IgAN) space put a sizeable dent in the stock (NASDAQ:OMER) and caused the Seattle-based firm to end the experiment with narsoplimab. Shares closed Oct. 16 at $1.54, down 73 cents, or 32%, after Omeros reported the interim analysis outcome of the trial called Artemis-IgAN.
Travere Therapeutics Inc.’s narrow phase III miss in the study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) had Wall Street speculating about the fate of the compound, which is available for the indication by way of accelerated approval in the U.S., having been given the nod in February.
The paper published June 19 in Nature Genetics that described a genome-wide analysis to narrow down the implicated pathogenic signaling pathways and “prioritize drug targets for IgA nephropathy [IgAN]” no doubt proved of great interest to developers, plenty of which are busy in the space.
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
San Diego-based Travere Therapeutics Inc. gained U.S. FDA accelerated approval for its dual endothelin angiotensin receptor antagonist, Filspari (sparsentan), to reduce proteinuria in adults with primary IgA nephropathy, or Berger’s disease.
Vera Therapeutics Inc.’s latest results from the phase IIb Origin trial with atacicept in patients with IgA nephropathy (IgAN) provided cause for optimism with regard to the phase III experiment targeted for the first half of this year – which should yield 36-week data in the first half of 2025 – and the company is budgeting to make the later-stage effort happen.
After Vera Therapeutics Inc.’s disappointing 24-week data from the Origin phase IIb study with atacicept in immunoglobulin A nephropathy (IgAN), Wall Street is looking forward to more results at 36 weeks, due later this year.
Calliditas Therapeutics AB expects its oral version of budesonide to be available early in the first quarter of 2022, following FDA approval for treating patients with progressive kidney disease primary immunoglobulin A nephropathy (IgAN). Branded Tarpeyo, the delayed-release capsules were cleared for use in reducing proteinuria in adults with primary IgAN at risk of rapid disease progression, usually determined as a protein-to-creatinine ration (UPCR) of 1.5 g/g or less.
Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other.
It’s all systems “go” for Travere Therapeutics Inc. and its sparsentan after meetings with the FDA paved the way for filings and potential accelerated approvals in the rare kidney disease IgA nephropathy and the kidney scarring condition focal segmental glomerulosclerosis.
