A regulatory plod that began in 2023 – and met with success in many other territories – at last crossed the U.S. FDA finish line when Novo Nordisk A/S secured approval of Awiqli (insulin icodec) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin.
The debated and ultimately stock-denting March 26 news from Wave Life Sciences Inc. pushed into the spotlight other firms working with INHBE and activin E.
Apparently put off by data with a higher dose, investors in Wave Life Sciences Inc. backed away after the company rolled out data from the phase I portion of its first-in-human Inlight trial evaluating 250 mg of WVE-007, an INHBE GalNAc-siRNA prospect, in otherwise healthy overweight or obese adults.
Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD).
What one analyst called an “intriguing” overall survival signal in phase III results has Karyopharm Therapeutics Inc. planning to meet with the U.S. FDA about a would-be sNDA filing for Xpovio (selinexor) in myelofibrosis (MF).
In a competitive and still-needy space where Apogee Therapeutics Inc. CEO Michael Henderson noted that “even modestly differentiated products are quickly becoming blockbusters,” his firm’s IL-13 antibody zumilokibart (zumi, APG-777) has turned up satisfying phase II data in part A of the phase II atopic dermatitis (AD) experiment called Apex in moderate to severe disease. “We’re still digesting the data,” Henderson added, pointing out that the results proved better than Apogee expected at both time intervals tested.
Attacking attention deficit hyperactivity disorder (ADHD) from two different angles, thanks to a new asset just brought aboard, should help Collegium Pharmaceutical Inc. protect its revenue stream in the pesky and widespread condition. Stoughton, Mass.-based Collegium disclosed its pact March 19 with Corium Therapeutics Holdings LLC for the former to buy the latter’s Azstarys (serdexmethylphenidate and dexmethylphenidate).
Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in type 2 diabetes (T2D).
Awaiting the potential U.S. FDA approval of a second product this year, Protagonist Therapeutics Inc. with partner Johnson & Johnson won the go-ahead for oral peptide Icotyde (icotrokinra), an IL-23 receptor antagonist, to treat moderate to severe plaque psoriasis in adults and pediatric patients 12 and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy.
Low expectations for Rhythm Pharmaceuticals Inc.’s phase III study dubbed Emanate with Imcivree (setmelanotide) in a handful of rare genetic obesities meant hardly any share price consequence, and the stock (NASDAQ:RYTM) closed March 17 at $87.68, down $2.83. “We’re not going to file [for approval] on any of these,” CEO David Meeker said, but the latest findings together represent “a solid building block going forward,” he added.
