June 20 Quick Takes: FDA approves argenx’s subcutaneous Vyvgart
Plus: Clozel provides Idorsia cash lifeline, a clinical hold for Arcellx and updates from Vera, Denali, Delve Bio and Turbine
argenx SE (Euronext:ARGX; NASDAQ:ARGX) said it expects to launch Vyvgart Hytrulo next month, after FDA approved the subcutaneous version of myasthenia gravis drug Vyvgart efgartigimod alfa-fcab. The company is counting on Vyvgart Hytrulo to further drive uptake of an FCRN antibody that has helped lift the biotech’s valuation north of $22 billion. Vyvgart Hytrulo incorporates Enhanze delivery technology from Halozyme Therapeutics Inc. (NASDAQ:HALO). A competing anti-FCRN antibody, rozanolixizumab from UCB S.A. (Euronext:UCB), is under priority review by FDA.
CEO Jean-Paul Clozel is providing Idorsia Ltd. (SIX:IDIA) with a $75 million credit facility that will extend the biotech’s cash runway through July. The company said this month it has entered exclusive negotiations with an undisclosed party for a strategic transaction around its Asia-Pacific business, worth up to CHF400 million ($447.4 million). Idorsia markets Pivlaz clazosentan in Japan to treat vasospasm associated with aneurysmal subarachnoid hemorrhage; it markets Quviviq daridorexant in the U.S. and Europe to treat insomnia, and plans to seek its approval in Japan. The biotech was spun out of Actelion Ltd. when Johnson & Johnson (NYSE:JNJ) acquired it...