Reata Pharmaceuticals Inc.’s hopes, as well as those of many people living with Alport syndrome, were dashed Dec. 8 when the FDA’s 13-member Cardiovascular and Renal Drugs Advisory Committee voted unanimously that the available evidence doesn’t show that the benefits of bardoxolone methyl outweighed its risks in treating the rare genetic condition.
The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas.
DUBLIN – Sanifit Therapeutics SA has found a taker for its phase III calcification inhibitor for kidney dialysis patients, SNF-472, in the shape of Vifor Pharma AG, which is acquiring the Spanish company outright for €205 million (US$231 million) up front, up to €170 million in potential clinical development, regulatory and market access milestones, as well as undisclosed commercial milestones.
Just months after completion of its spinout from Merck & Co. Inc., Organon & Co. has revealed plans to fold in a second acquisition: the Finnish firm Forendo Pharma Ltd., which is advancing an early stage candidate for endometriosis. The deal includes $75 million up front and as much as $870 million in potential milestone payments for Forendo owner Karolinska Development AB, which said the buyout is one of the largest biotech transactions in the Nordic region. Earlier deals rounding out the company's recent story include a Merck-facilitated acquisition of Alydia Health Inc. and a July deal with Obseva SA.
In a recent study, a team of researchers at the University of Washington and Seattle Children's Research Institute have discovered that spiny mice can regenerate severely damaged internal organs that, in other mice, would lead to fatal organ failure.
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.
Results from two pivotal phase III trials testing Glaxosmithkline plc's daprodustat against anemia due to chronic kidney disease (CKD) found the oral hypoxia-inducible factor prolyl hydroxylase inhibitor helped both non-dialysis and dialysis patients improve or maintain hemoglobin levels without increased cardiovascular risk vs. standard-of-care erythropoietin stimulating agents. Though already approved in Japan as Duvroq, what future the drug might face in the U.S., where the same-class drug roxadustat garnered an FDA complete response letter, remained an open question.
Allara Health Inc. officially launched its diagnostic test for polycystic ovary syndrome (PCOS) this week, but word of mouth has already established a waitlist of more than 10,000 women. The diagnostic tool evaluates a full panel of hormonal and metabolic markers, which are used with patient-reported symptoms, to diagnose the increasingly common condition.
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.
Shares of Angion Biomedica Corp. tumbled more than 50% Oct. 27 on disappointing top-line data from its phase III study testing ANG-3777’s ability to improve organ function in patients receiving deceased donor kidney transplants. The company’s management, however, remained cautiously optimistic that the safety results and signals of biological activity could bode well for an exploratory phase II study testing the drug in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, which is expected to read out later this quarter.
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