Shares in Ardelyx Inc. have crashed after its tenapanor, under FDA review for managing phosphate levels in chronic kidney disease (CKD), ran into trouble with the regulator. The company said that the FDA has identified “deficiencies” in the data package, which prevent discussions about labeling and postmarketing commitments.
Despite assembling the largest body of data the FDA said it may ever see for a drug intended to treat anemia due to chronic kidney disease, Fibrogen Inc. will have to get even more trial data to push roxadustat over the finish line in the U.S. – if the FDA follows the advice of its Cardiovascular and Renal Drugs Advisory Committee.
Following a priority review, the FDA approved Bayer AG’s Kerendia (finerenone) for chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A non-steroidal mineralocorticoid receptor antagonist, Kerendia targets a key driver in CKD and has proven positive as well with regard to cardiovascular outcomes – risked especially by patients with loss of kidney function.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.
TORONTO – Femtherapeutics Inc. is combining artificial intelligence-driven machine learning and 3D design to manufacture a device for relieving urinary incontinence and discomfort in women suffering pelvic organ prolapse. The custom-made pessary is intended to support vaginal tissues displaced because of the condition, replacing conventional pessaries that company officials said can result in irritation and penetrate soft tissues causing bleeding.
TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.
LONDON – Alentis Therapeutics SA is now equipped to deliver initial proof of concept for its universal approach to treating fibrosis, after raising $67 million in an oversubscribed series B.
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