Following the disclosure of positive data from a phase 2 trial of its idiopathic pulmonary fibrosis (IPF) drug pamrevlumab, FibroGen (NASDAQ:FGEN) saw its stock skyrocket on Monday (August 7) and Tuesday (August 8).
At market close on Tuesday, the company’s shares had soared 48.2 percent over the one-day period to $49.50. After hours trading saw FibroGen’s share price dip slightly to $49.45 as of 6:08 p.m. EST.
The main aspect of the trial saw 103 patients getting a dose of the company’s pamrevlumab or placebo in a randomized fashion for a total of 48 weeks.
FibroGen to meet with the FDA for Phase 3 models and present more data at upcoming conference
“Pamrevlumab met the primary efficacy endpoint of change of forced vital capacity percent predicted, a measure of change in lung volume, from baseline to week 48 of the study,” the company said in the announcement.
FibroGen will meet with the US Food and Drug Administration regarding the next steps for pamrevlumab. CEO Tom Neff told investors the company hadn’t yet decided on a phase 3 model and was currently “considering two or three different trial designs.”
More information on the trial is set to be presented by FibroGen at an upcoming European Respiratory Society conference.
As part of this trial, 57 patients in total were also randomized in their treatments. With 36 patients receiving a dose of pirfenidone with pamrevlumab or placebo and 21 patients got doses of nintedanib and pamrevlumab or placebo. Both groups were evaluated for 24 weeks.
Dr. Peony Yu, the company’s chief medical officer, said in the company’s press release that FibroGen is evaluating more tests and will report more data in the future.
“We believe these results support a Phase 3 program in patients suffering from this debilitating and deadly disease,” Dr. Yu added.
In a report to investors, Stifel (NYSE:SF) analyst Dr. Thomas Shrader, who covers FibroGen, increased the raised company target price from $38 to $80 based on these results.
“Based on previous IPF trials this result seems more than could have been hoped for,” the report indicated. “We are adding IPF to our model with a 50% probability of success, yearly cost of about $80,000 (slightly lower than existing drugs) and a penetration of 15% (two currently marketed drugs).”
CNBC reported as part of the company’s second quarter financial results, FibroGen announced a 33.2 million loss which caused an EPS (earnings per share) loss of 48 cents per share, “slightly missing Wall Street’s expectations of a loss of 47 cents per share.”
In June, following a top pick selection from Citigroup (NYSE:C), the company saw a substantial increase in its stock, which prompted Joel Beatty, a biotech analyst with City, to say their anemia candidate rozadustat has the potential to become a top drug for the treatment of the condition.
FibroGen has seen a consistent upstream in its trading since 2017 began, FGEN is currently enjoying a 153.51 percent raise over a year-to-date period.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.