FibroGen (NASDAQ:FGEN) shares are down a massive 77% at the time of writing today after it announced topline results from a Phase 3 trial evaluating pamrevlumab for the treatment of idiopathic pulmonary fibrosis.
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While the drug was observed to be generally safe and well tolerated, the trial failed to achieve its primary endpoint of change in forced vital capacity (FVC) from baseline at week 48. At week 48, the placebo leg of the study had a mean decline in FVC of 330ml as compared to 260ml in the pamrevlumab leg.
Further, the trial also failed to achieve its secondary endpoint of time to disease progression. Consequently, FibroGen is discontinuing the Phase 3 trial and will focus on additional pamrevlumab studies and the commercialization of roxadustat. It expects Phase 3 data for pamrevlumab in ambulatory DMD patients in the third quarter of 2023, in locally advanced pancreatic cancer in the first half of 2024, and in metastatic pancreatic cancer.
Next, the company is looking to undertake a substantial cost decrease in the U.S. in a bid to extend its cash runway into 2026.
Today’s price erosion comes after a nearly 37% surge in FibroGen shares over the past year. Short interest in the stock currently stands at about 6.7%.
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