FibroGen Shares Are Tumbling After Another Pamrevlumab Trial Setback

FibroGen Inc FGEN shares are trading lower after the company faces another trial setback.

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 mean decline in FVC from the baseline to week 48 was 260 ml with pamrevlumab, compared to 330 ml with the placebo.

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).

Recently, FibroGen's Phase 3 LELANTOS-1 trial of pamrevlumab for non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids did not meet the primary endpoint of the Performance of the Upper Limb 2.0 score at week 52 compared to baseline.

In May, FibroGen released data from the MATTERHORN Phase 3 trial of roxadustat for anemia in patients with transfusion-dependent lower-risk myelodysplastic syndromes, showing that the 140-patient study did not meet its primary endpoint. 

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.