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.
Dimerix Ltd. has out-licensed lead candidate DMX-200 to Advanz Pharma Corp. for focal segmental glomerulosclerosis (FSGS) in a carve-out deal that grants commercialization rights to Advanz in the European Union, the U.K., Switzerland, Canada, Australia and New Zealand.
Dimerix Ltd. has out-licensed lead candidate DMX-200 to Advanz Pharma Corp. for focal segmental glomerulosclerosis (FSGS) in a carve-out deal that grants commercialization rights to Advanz in the European Union, the U.K., Switzerland, Canada, Australia and New Zealand.
Three months after Intercept Pharmaceuticals Inc. received its second complete response letter for obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis, causing a mass layoff and the decision to drop development for the indication, Bologna, Italy-based Alfasigma SpA agreed to acquire the company for $19 per share in cash, or about $793.8 million.
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.
Zevra Therapeutics Inc. will acquire Acer Therapeutics Inc. in a $91 million deal that combines two companies with expertise in rare diseases. Acer has struggled since its hot flash drug, ACER-801 (osanetant), failed to hit statistical significance in a phase IIa proof-of-concept study in March 2023. The stumble came amidst the launch of Acer’s Olpruva, a sodium phenylbutyrate for oral suspension therapy approved by the U.S. FDA in late December 2022 for treating urea cycle disorders. The day before the Zevra merger was announced, Acer reacquired the worldwide development, commercialization and economic rights to Olpruva from its development partner, Relief Therapeutics Inc.
RSS
