Shares of Fibrogen $FGEN soared 62% after the market close on Monday as the San Francisco-based biotech gave investors a sign that its mid-stage study of pamrevlumab delivered a statistically significant result for idiopathic pulmonary fibrosis. FibroGen ended the day with a market cap of $2.3 billion, with the new mid-stage data adding more than a billion dollars to that.
At least one prominent analyst has changed his mind about this drug now, offering peak sales estimates scraping the blockbuster mark.
Next stop, according to the biotech: Phase III for IPF, with more data coming in this drug for pancreatic cancer later this year.
Some analysts following Fibrogen have seen this drug as something of a dark horse, coming in largely unnoticed behind the lead program for roxadustat for chronic kidney disease, which the biotech expects to file next year – all things going well.
And things have been going well for FibroGen, which reported near the beginning of this year that its AstraZeneca-partnered Phase III anemia studies on roxadustat in China scored promising data. FibroGen’s drug is in head-to-head competition with Akebia with a therapeutic approach that also mimics the effect of high altitudes in addressing anemia.
Leerink’s Geoffrey Porges acknowledged the sudden turnaround for a program he had zero confidence in. He noted:
We previously afforded pamrevlumab 0% probability-of-success (PoS) in our model given prior development delays and some disappointments; based on the compelling proof of concept phase II results we are increasing that to 35% PoS, which contributes $392mm in worldwide sales in 2022E growing to $892mm to 2025E (current IPF drugs Ofev and Esbriet did combined sales of ~$1.5bn in 2016 after only two years on the US market).
“We are very encouraged by the topline IPF Phase 2 clinical study results that we announced today, in which pamrevlumab-treated patients had a significantly lower rate of decline in lung function, as compared to the placebo-treated patients. In addition, pamrevlumab continued to be well tolerated as a monotherapy in this IPF study, and was well tolerated in combination with pirfenidone and nintedanib,” said Thomas B. Neff, FibroGen’s CEO. “We believe that the promising outcomes of these studies enable us to advance pamrevlumab into Phase III clinical development.”
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