Amgen's Dazodalibep Hits Primary Goal in Sjogren's Trial, No Approved Treatments Exist
AMGN sits 46% above its 52-week low of $269.77.
Summary
Amgen's dazodalibep met its primary endpoint in a Phase 3 trial for Sjogren's disease, showing statistically significant and clinically meaningful improvement in disease activity at week 48. The disease affects about 1% of the global population and has no approved treatments in the US, making this a potential first-in-class opportunity. Safety was manageable, with most adverse events mild to moderate and few discontinuations. This positive readout comes after a rough stretch for Amgen—the Tavneos withdrawal proposal, a cybersecurity breach, and a 9% share drop on Novartis's pelacarsen failure. Detailed data will be presented at an upcoming medical meeting, and the trial is expected to complete in Q4 2026. Regulatory filing is contingent on the OASIZ 303 study, expected to read out in Q4 2026; William Blair says two positive Phase 3 trials will be required for FDA approval. Amgen shares rose 3.54%. Johnson & Johnson and Novartis are also developing Sjogren's drugs, so competitive positioning matters.
Updated with a Benzinga report · What changed
Updates
· Benzinga — Regulatory filing is contingent on the OASIZ 303 study, expected to read out in Q4 2026; William Blair says two positive Phase 3 trials will be required for FDA approval. Amgen shares rose 3.54%.
At the time of this announcement, AMGN was trading at $394.53 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $212.6B. The 52-week trading range was $269.77 to $447.03. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.