Today, a brief rundown of news involving executive changes at Stoke Therapeutics and the Centers of Medicare and Medicaid Services, as well as updates from Incyte, Precision BioSciences and AstraZeneca that you may have missed.
Edward Kaye, CEO of genetic medicines developer Stoke Therapeutics, will step down on Wednesday and be replaced on an interim basis by Ian Smith, a company board member and former chief financial officer at Vertex Pharmaceuticals. Board Chairman Arthur Tzianabos has been appointed to interim executive chairman. Stoke didn’t disclose a reason for the change-ups, which come on the heels of a licensing agreement with Biogen. Tzianabos did note that he thinks Smith will provide “continuity” and support as the company works toward its strategic and growth goals. Kaye, who has been Stoke’s top executive for most of the past decade, isn’t stepping back entirely. He plans to stay on as a board director. — Jacob Bell
The Centers for Medicare and Medicaid Services has signed agreements with the 12 companies whose drugs will be involved in the next round of price negotiations, the agency said Friday. The CMS will next hold a series of roundtable meetings and make initial “maximum fair price” offers to drugmakers before working to negotiate a final price by Nov. 1. Fifteen drugs are subject to negotiations in this round, including diabetes and obesity drugs Ozempic and Wegovy, cancer medications Calquence and Ibrance and depression treatment Vraylar. The new prices will take effect in 2027. — Jonathan Gardner
Shares in Incyte dropped by double digits Monday morning after clinical trial results released by the company for an experimental drug fell somewhat short of Wall Street's expectations. The drug, called povorcitinib, met its goal in two Phase 3 trials involving people with moderate-to-severe hidradenitis suppurativa, an inflammatory skin condition. According to Incyte, treatment reduced abscesses and inflammatory nodules by 50% or more in a significantly greater share of participants than did placebo. Some analysts and investors were anticipating a greater difference between study groups, however. Incyte plans to seek regulatory approval. — Ned Pagliarulo
The Food and Drug Administration has given Precision BioSciences a green light to begin enrolling people in the U.S. into a clinical trial testing its gene editing treatment for chronic hepatitis B infection. Already underway in Moldova, Hong Kong and New Zealand, the trial is testing ascending doses of Precision's therapy, which uses a nuclease called ARCUS to cut DNA. Precision released initial data last month from the first cohort of patients treated in the study, and the company intends to release more results later this year. — Ned Pagliarulo
AstraZeneca on Tuesday tapped South Korea-based biotech Alteogen for help manufacturing subcutaneous versions of its cancer drugs. AstraZeneca’s therapies Enhertu, Imfinzi and Imjudo are all delivered intravenously, and developing subcutaneous versions could be more convenient for patients while extending their market exclusivity. Alteogen has already cut a deal with AstraZeneca’s partner Daiichi Sankyo to develop a subcutaneous Enhertu, and previously collaborated with Merck & Co. on an under-the-skin Keytruda shot. — Jonathan Gardner
