Results from the first trial testing the oral autotaxin inhibitor ziritaxestat in adults with diffuse cutaneous systemic sclerosis have encouraged its originator, Galapagos NV, to explore next steps for the program, it said on Sept. 11.
A pivotal test of Satsuma Pharmaceuticals Inc.'s dry powder acute migraine candidate, STS-101, found neither of two doses evaluated met the co-primary endpoints, freeing people from pain or their most bothersome symptom two hours post-administration.
Shares of Intra-Cellular Therapies Inc. (NASDAQ:ITCI) climbed 72.8% to $31.86 on Sept. 9 following news that its FDA-approved schizophrenia drug, Caplyta (lumateperone), could also help improve bipolar depression.
A phase III trial of AZD-1222, an experimental coronavirus vaccine developed by Astrazeneca plc and Oxford University, has been paused due to an unexplained illness that occurred in the U.K., the company said on Sept. 8.
Good news from a pivotal phase III trial of Albireo Pharma Inc.'s odevixibat has moved the world one step closer to going from no treatments for the rare genetic liver disease PFIC to possibly having two: Albireo's entrant and another candidate, maralixibat from Mirum Pharmaceuticals Inc.
Lixte Biotechnology Holdings Inc., a small OTC-listed company developing inhibitors of protein phosphatases to be used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers for treating cancer, has filed to raise $10.7 million in a public offering of shares on Nasdaq.
Rain Therapeutics Inc., a California company developing targeted cancer therapies with a biomarker-based strategy, has raised a $63 million series B round led by Boxer Capital to support its development of the small-molecule MDM2 inhibitor RAIN-32 (milademetan) for the potential treatment for liposarcoma and other cancers.
The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing.
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo.
