The company recently released topline results from its Phase 3 ZEPHYRUS-1 trial evaluating pamrevlumab's safety and efficacy in patients with idiopathic pulmonary fibrosis (IPF).
The trial failed to meet the primary endpoint of change in forced vital capacity (FVC) at week 48.
The secondary endpoint of time to disease progression was also not met.
Pamrevlumab was generally safe and well tolerated, with most treatment-emergent adverse events being mild or moderate.
Serious adverse events were observed in 28.2% of patients in the pamrevlumab group and 34.3% in the placebo group.
Due to these results, the second Phase 3 trial, ZEPHYRUS-2, will be discontinued.
FibroGen anticipates reporting topline data from Phase 3 studies for the treatment of ambulatory DMD patients (LELANTOS-2) in Q3 2023, locally advanced pancreatic cancer (LAPIS) in H1 2024, and metastatic pancreatic cancer (Precision Promise).
FibroGen plans to implement a significant cost-reduction effort to extend the cash runway into 2026.
"FibroGen's focus will be on reporting the additional pamrevlumab studies, advancing our pipeline, and continuing commercialization of roxadustat in China and in countries where approved," said Enrique Conterno, CEO, FibroGen.
As of March 31, 2023, the company's cash was $373.6 million.
Price Action: FGEN shares are down 76.1% at $3.84 during the premarket session on the last check Monday.
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