Investors sorting through NGM Biopharmaceuticals Inc.'s interim results from the fourth and final cohort of the adaptive phase II trial with aldafermin in nonalcoholic steatohepatitis (NASH) may have felt let down when comparing the data to previous cohorts' outcomes. Shares of the South San Francisco-based firm (NASDAQ:NGM) closed Monday at $10.78, having sunk $2.77 or 20.4%.

WASHINGTON – While the vast majority of people infected with respiratory syncytial virus (RSV) muddle through with mild, cold-like symptoms, for infants, the associated bronchiolitis can make it extremely difficult to breathe and feed. Thousands require inpatient care for the infection each year, necessitating hospitals to be built with a winter surge of admissions in mind, driven in large part by RSV in both the very young and old.

Arm and hand prosthetics have long been the focus for researchers aiming to offer sensation as well as more precise and easily controlled movement by connecting patient nerves to sensors in the prosthetic. But now that effort has been extended to leg prosthetics as well.

WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). Shionogi & Co. Ltd., which is advancing its investigational antibiotic, cefiderocol, in the same indications, also shared new phase III data supporting its use in the high-risk population.

WASHINGTON – A little more than a year after first reporting phase IIb results showing oral TORC1 inhibitor RTB-101 reduced the number of respiratory tract infections (RTIs) in older adults, Restorbio Inc. is illuminating what may be the mechanism behind its efficacy: the up-regulation of innate antiviral immunity. The data, presented at the Infectious Disease Society of America's IDWeek 2019, put the company on track to move into two phase III data readouts next year. 

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.

A large-scale U.K. clinical trial of a portable electronic nose device has shown it is possible to distinguish bacterial from viral infection in an unselected population of patients presenting with a respiratory tract infection (RTI) symptoms, at the point of care.

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.