Leerink analyst Geoffrey Porges says that while Amgen did not disclose the reasons for the complete response letter it received for Parsabiv for the treatment of secondary hyperparathyroidism in patients suffering from chronic kidney disease on hemodialysis, it is likely safety-related. The analyst still expects the FDA to ultimately approve Parsabiv, but anticipates "significant" warning language, and probably a Risk Evaluation and Mitigation Strategy program regarding cardiac safety. Porges reiterates a Market Perform rating and $201 price target on the shares.

Amgen "provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE(R) in chronic obstructive pulmonary disease, or COPD, which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT. We are encouraged by the results of the COURSE Phase 2a proof-of-concept trial, which investigated tezepelumab in moderate to very severe COPD patients, across a broad range of eosinophil levels, irrespective of inflammatory drivers, emphysema, chronic bronchitis and smoking status. This study did not exclude any patients based on their baseline eosinophil count (BEC) and intentionally enrolled patients with a broad range of BECs. Overall, tezepelumab numerically reduced the annualized rate of moderate or severe COPD exacerbations versus placebo by 17% (90% CI: -6, 36; p=0.1042). Of note, more reductions were observed in a prespecified subgroup of patients with BEC greater than or equal to150 cells/muL (37% [95% CI: 7, 57]). The trend in reduction was greater in a small number of subjects with BEC greater than or equal to300 cells/microL."