June 26 Quick Takes: Fibrogen sinks on IPF discontinuation

Shares of FibroGen Inc. (NASDAQ:FGEN) now reflect almost zero pipeline value after falling 83% to $2.71 Monday on news the company’s pamrevlumab failed to meet the primary endpoint of change from baseline in forced vital capacity (FVC) at week 48 (p=0.29) in ZEPHYRUS-1, the first of two Phase III trials to treat idiopathic pulmonary fibrosis (IPF). The secondary endpoint, FVC percent-predicted decline of ≥10% or death, was also not met. Consequently, FibroGen said it would discontinue ZEPHYRUS-2, its second Phase III study. The miss follows a major blow to FibroGen in 2021 when FDA issued a complete response letter for Evrenzo roxadustat to treat anemia in chronic kidney disease. The company aims to extend its cash runway into 2026 by cutting costs.

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said that both Type I diabetes patients with at least one year of follow-up in its Phase I/II trial of islet cell therapy VX-880 are now insulin independent with HbA1c values of 5.3% and 6.0%, respectively. Among six patients dosed, all demonstrated endogenous insulin secretion, improved HbA1c and time-in-range on continuous glucose monitoring, as well as reduction or elimination of exogenous insulin use. Vertex will now advance VX-880 to Part C of the trial, which allows for concurrent dosing of patients at the full target dose. ...