HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.
After its momentum-building end-of-phase II meeting with the FDA, Contrafect Corp. will start a single phase III trial of exebacase to treat Staphylococcus aureus bacteremia before year-end.
Minerva Neurosciences Inc. CEO Rémy Luthringer said his firm knew about the cyberattack on a contractor helping with the roluperidone phase III trial in schizophrenia "toward the end of the summer," when "the provider was trying to solve the problem" and ultimately did. But the attack still meant an enrollment delay, and Wall Street reacted accordingly. Despite imminent, possibly transforming data in major depressive disorder (MDD), investors pushed Minerva shares (NASDAQ:NERV) down $2.04, or 26.3%, Tuesday to close at $5.71.
The Cushing's syndrome market is heating up with three second-generation drugs in late-stage development to join the two approved medications, Signifor (pasireotide, Recordati SpA) and Korlym (mifepristone, Corcept Therapeutics Inc.), as well as a couple of off-label options.
Wall Street will have to wait until the American Heart Association (AHA) meeting next month in Philadelphia for full data from Resverlogix Inc.'s phase III BETonMACE trial with apabetalone, but disclosure of the endpoint miss was enough to send investors fleeing.
Shares of Seattle Genetics Inc. (NASDAQ:SGEN) rose 12.4% to $85.40 on news that an antibody-drug conjugate (ADC) it is developing with Tokyo-based Astellas Pharma Inc., when combined with Keytruda (pembrolizumab, Merck & Co. Inc.), shrank tumors in the majority of people participating in a phase I first-line bladder cancer study.
BARCELONA, Spain – This year's theme at the European Society for Medical Oncology's (ESMO) 2019 annual meeting is "translating science into better patient care."
Aravive Inc.'s chief medical officer, Gail McIntyre, told BioWorld that a "very clever mechanism" designed by researchers at Stanford University helped lead to positive data from the first 12 patients of the ongoing phase Ib part of the phase Ib/II experiment with AVB-500 against notoriously hard-to-beat ovarian cancer.
Pfizer Inc. edged closer to Dermira Inc. in the rush for an approved treatment for atopic dermatitis (AD), a field dominated by Regeneron Pharmaceutical Inc.'s FDA-approved blockbuster, Dupixent (dupilumab), as Pfizer reported positive top-line results from a phase III trial evaluating the efficacy and safety of its oral JAK1 inhibitor, abrocitinib.
Top-line results from Enanta Pharmaceuticals Inc.'s Argon-1 phase IIa study of EDP-305 for the treatment of nonalcoholic steatohepatitis (NASH) found one of the two doses of the drug tested met the study's primary endpoint, alanine aminotransferase (ALT) reduction at week 12, contributing further evidence for the drug's mechanism of action, farnesoid X receptor (FXR) agonism. But the non-biopsy study appears to have left investors without proof for something more even more valuable: a clear case for differentiation vs. FXR first-mover Ocaliva (obeticholic acid, Intercept Pharmaceuticals Inc.). Appearing to reflect the sentiment, Enanta's shares (NASDAQ:ENTA) fell 15.1% to $60.51 on Thursday.