Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
In a recent study led by Soman Abraham from Duke University, investigators observed that an increase in nociceptive sensory nerves in urinary tract biopsies from patients with recurrent urinary tract infections (rUTIs) was linked to elevated nerve growth factor (NGF) from monocytes and mast cells. This overgrowth of nerve cells appeared to cause lingering symptoms after rUTIs. These findings, appearing in the March 1, 2024, online edition of Science Immunology, have the potential to provide a new approach to managing symptoms of rUTIs that would reduce unnecessary antibiotic usage.
Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld. “We’re looking for a breakthrough in rare diseases – to develop new treatments for [niche] markets with large unmet demand.”
Wall Street got what it wanted from Vera Therapeutics Inc. with atacicept in IgA nephropathy (IgAN) and rewarded shares of the Brisbane, Calif.-based firm (NASDAQ:VERA), pushing them to close Jan. 25 at $25.31, up $8.29, or 49%.
Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect.
Kanna Health Ltd. has received clearances by the FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its IND application and clinical trial application (CTA), respectively, to initiate a first-in-human phase I trial of KH-001 besylate (KH-001) for premature ejaculation.
Otsuka Pharmaceutical Co. Ltd.’s sibeprenlimab (VIS-649) met the primary efficacy endpoint in a phase II trial for treating immunoglobulin A nephropathy (IgAN), demonstrating that 12 months of treatment resulted in significant reductions in proteinuria compared to placebo.
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
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.
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
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