With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
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.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Less than a month after would-be competitor DBV Technologies SA suffered a regulatory setback with its peanut allergy patch candidate, Aimmune Therapeutics Inc. – which at the start of the year gained FDA clearance for Palforzia in the same space – is undergoing an all-cash takeover valued at $2.6 billion by Nestle SA unit Nestle Health Science SA.
The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair.
Millendo Therapeutics Inc. in April decided to scrap work altogether with livoletide in Prader-Willi syndrome after a phase IIb study fell short of statistical significance, but hope remains alive for – among others in the space – Soleno Therapeutics Inc., another recent newsmaker with once-daily diazoxide choline controlled-release tablets in PWS.
Vancouver, British Columbia-based Sierra Oncology Inc. during its recent earnings call offered an update on momelotinib, in phase III development for myelofibrosis. Enrollment in the study won’t be finished until the fourth quarter of 2021.
Annexon Biosciences Inc.’s handsome $250 million IPO this summer verified the mounting interest in its two front-running C1q inhibitors: ANX-005, which has turned up promising phase Ib data in Guillain-Barre syndrome (GBS), with a phase II/III effort planned for next year, and ANX-007, due to enter a phase II experiment in geographic atrophy (GA) during 2021 as well.
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.
