The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II study called Willow, testing INS-1007 once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE).
BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor, remdesivir, which was originally developed for Ebola, four days after a U.S. patient was said to have recovered by using the drug candidate.
Eli Lilly and Co. and Incyte Corp. are working on atopic dermatitis (AD) from several angles and finding success. The most recent example is the positive top-line results from their collaborative phase III trial of baricitinib in treating adults with moderate to severe atopic dermatitis that show the oral selective JAK inhibitor met the study’s primary and secondary endpoints.
Bayer AG and Merck & Co. Inc. took Wall Street by surprise in November with their phase III success testing vericiguat in heart failure (HF), such that the guanylate cyclase stimulator’s odds not only have improved significantly but also in a different way than imagined before.
GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52.
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections.
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class.
Expectations that a phase III trial of Ipsen SA's palovarotene will miss its primary endpoint of reducing abnormal bone growth among people with a rare bone disorder led the company to pause dosing in that study and another as it evaluates next steps.