Randy Osborne

Otsuka Pharmaceutical Co. Ltd. will likely look next to expand the label of Simtriyo (centanafadine) into patients with comorbid anxiety, having won the U.S. FDA's green light as a once-daily extended-release capsule for attention deficit hyperactivity disorder (ADHD) in adults plus pediatrics age 6 years and older who weigh at least 20 kg (about 44 lbs.).

Altimmune Inc. and Wall Street are mulling the size and scope of a phase III trial after positive top-line results were made public from the Reclaim phase II trial with pemvidutide (pemvi), a balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder (AUD). CEO Jerry Durso called the Reclaim data “the most robust we've seen” in the condition.

The saga of Capricor Therapeutics Inc.'s allogeneic cell therapy deramiocel for cardiomyopathy in Duchenne muscular dystrophy (DMD) added another bleak chapter as the U.S. FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted on the question of whether the available data provide “substantial evidence” that the drug works. Balloting turned out 9 no, 3 yes.

The hot in vivo CAR T therapy space bubbled with news again as Johnson & Johnson (J&J) apparently forsook partner Legend Biotech Corp. and tapped

Bad news from the Novo Nordisk A/S phase III trial called Zeus with IL-6 inhibitor ziltivekimab struck a blow to some drug developers' theory about heart disease – and to their stocks. An update on the Zeus trial weighing the safety and efficacy of monoclonal antibody ziltivekimab nicked shares of Bagsvaerd, Denmark-based Novo (NYSE:NVO), which closed July 31 at $47.08, down $4.54.

“Highly complementary” pipelines could mean a merger deal would benefit Astrazeneca plc as well as Bristol Myers Squibb Co. (BMS), Leerink analyst David Risinger said in a report. The potential setup had Wall Street abuzz as published rumors made the rounds. Both firms were keeping mum.

J.P. Morgan analyst Jessica Fye said officials at Vertex Pharmaceuticals Inc. were “unfazed” by Otsuka Pharmaceutical Co. Ltd.'s new data from the phase III, 605-patient Visionary trial showing that Voyxact (sibeprenlimab), the groundbreaking A proliferation inducing ligand (APRIL) blocker cleared by the U.S. FDA last year for proteinuria in IgA nephropathy (IgAN), stabilizes estimated glomerular filtration rate and returns declined kidney function to the baseline physiologic rate over a two-year period.

Attovia Therapeutics Inc. became the latest to join what's become the year's IPO parade, pricing its upsized sale of 17 million shares at $17 each for $289 million in proceeds. The San Carlos, Calif.-based company came out of the gate strong, closing Aug. 5 (NASDAQ:ATTO) at $21.90, up $4.90, or 28.8%.

Moderna Inc. scored U.S. FDA clearance for Mflusiva (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 and older.

With Moderna Inc.'s U.S. FDA clearance of new mRNA influenza vaccine Mflusiva (mRNA-1010) in the rearview, Wall Street is eagerly anticipating phase