PERTH, Australia – Certa Therapeutics Pty Ltd. founder and CEO Darren Kelly knows a thing or two about launching biotech companies. He spun out Fibrotech Therapeutics in 2006 from the University of Melbourne, which was one of the Medical Research Commercialization Fund’s first investments.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analysis of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors.
Strive Health LLC has raised $140 million in a series B funding round led by Capitaig, Alphabet’s independent growth fund. The round also includes Redpoint Ventures, and current investors NEA, Town Hall Ventures, Ascension Ventures, and Echo Ventures. This funding round brings the Denver-based kidney care company’s total funding to $223.5 million.
The Institute for Clinical and Economic Review (ICER) took Fibrogen Inc., of San Francisco, to task for not disclosing data from completed roxadustat trials.
A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it.
Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.
In terms of cellular diversity, it may not be the brain, but the kidney boasts more cell types than most other organs. Now, researchers have used single-cell RNA sequencing to identify further subtypes of cells in the kidney, and gain new insights into the molecular mechanisms of chronic kidney disease.
Shares of Tricida Inc. (NASDAQ:TCDA) fell 47.2% to $4.37 on Oct. 29 after the company said the FDA would require data on how veverimer, its investigational therapy for metabolic acidosis in patients with chronic kidney disease (CKD), impacts CKD progression to support an accelerated approval. The news followed a complete response letter that met the NDA in August.
Akebia Therapeutics Inc. CEO John Butler said “a clear path forward” exists for vadadustat in chronic kidney disease (CKD) despite negative phase III safety findings, and the company plans to file for approval as early as next year in the U.S. and Europe.
