Pharmaceutical Industry Roundup: Executive Changes, Drug Pricing Negotiations, and Clinical Trial Updates

Stoke Therapeutics Announces Leadership Transition

Stoke Therapeutics, a genetic medicines developer, is undergoing a significant leadership change. Edward Kaye, the company's longtime CEO, will step down on Wednesday. Ian Smith, a board member and former chief financial officer at Vertex Pharmaceuticals, will take over as interim CEO. Additionally, Board Chairman Arthur Tzianabos has been appointed interim executive chairman.

This transition comes on the heels of a recent licensing agreement with Biogen. Tzianabos expressed confidence that Smith would provide continuity and support as the company pursues its strategic and growth objectives. Kaye, who has led Stoke for most of the past decade, will remain on the board of directors.

Medicare Drug Price Negotiations Advance

The Centers for Medicare and Medicaid Services (CMS) has made significant progress in its drug pricing initiative. All 12 pharmaceutical companies targeted for the second round of Medicare price negotiations have agreed to participate. The CMS has signed agreements with these companies, whose drugs will be subject to price talks.

The negotiation process will include a series of roundtable meetings, followed by initial "maximum fair price" offers from CMS to the drugmakers. The goal is to finalize negotiated prices by November 1. Fifteen drugs are involved in this round, including popular medications such as Ozempic and Wegovy for diabetes and obesity, Calquence and Ibrance for cancer, and Vraylar for depression. The new prices resulting from these negotiations will take effect in 2027.

Clinical Trial Results and Regulatory Updates

Incyte faced a setback as its shares dropped following the release of clinical trial results for povorcitinib, an experimental drug for hidradenitis suppurativa. While the drug met its primary goal in two Phase 3 trials, the efficacy fell short of some analysts' expectations. Despite this, Incyte plans to seek regulatory approval for the treatment.

In other regulatory news, Precision BioSciences received FDA clearance to begin enrolling U.S. patients in a clinical trial for its gene editing treatment targeting chronic hepatitis B infection. The trial, which uses the ARCUS nuclease technology, is already underway in Moldova, Hong Kong, and New Zealand. Precision BioSciences plans to release additional data from the study later this year.

AstraZeneca Pursues Subcutaneous Drug Formulations

AstraZeneca is partnering with South Korean biotech firm Alteogen to develop subcutaneous versions of its cancer drugs. This collaboration aims to create more convenient formulations of AstraZeneca's intravenous therapies, including Enhertu, Imfinzi, and Imjudo. The move could not only improve patient experience but also potentially extend market exclusivity for these drugs.

Alteogen has previously worked with AstraZeneca's partner Daiichi Sankyo on a subcutaneous version of Enhertu and has collaborated with Merck & Co. on an under-the-skin formulation of Keytruda. This latest partnership underscores the growing trend in the pharmaceutical industry towards developing more patient-friendly drug delivery methods.