Earlier today, FibroGen Inc FGEN said its Phase 3 ZEPHYRUS-1 trial of pamrevlumab in idiopathic pulmonary fibrosis (IPF) did not meet the primary endpoint of change in forced vital capacity (FVC) from baseline at week 48 or the secondary endpoint of a decline in FVC percent predicted of at least 10% or death.
Wiliam Blair has downgraded the stock to Market Perform.
The says FibroGen’s choice to discontinue the ZEPHYRUS-2 trial in IPF likely indicates a lack of any observed activity from pamrevlumab.
Regarding upcoming data readouts, the Phase 3 LAPIS trial in locally advanced pancreatic cancer (LAPC) is supported by limited data, and given that there was a previous interim look at event-free survival that prompted the trial to continue to the overall survival primary endpoint, the analyst writes that the investors do not have confidence in the trial.
For the Phase 3 LELANTOS-2 trial of pamrevlumab in ambulatory Duchenne muscular dystrophy, but given the recent trial failure in non-ambulatory patients with Duchenne Muscular Dystrophy, the analyst has low expectations for success in this indication.
Price Action: FGEN shares are down 82.5% at $2.80 on the last check Monday.
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