The biopharmaceutical company FibroGen, Inc. (FGEN) has been seeing its stock’s price falling 23.81% in pre-market trading today. The decline came following sharing of an update by the company about a review of its new drug application by a committee of FDA and release of quarterly results.
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Being a biopharmaceutical company, FibroGen Inc. is dedicated to the discovery, development, and commercialization of first-in-class drugs. In addition to its pioneering expertise in the field of hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology, the Company develops treatments for unmet needs using its proprietary technologies. Roxadustat, a small molecule oral inhibitor of HIF prolyl hydroxylase activity that causes anemia associated with chronic kidney disease, is currently being developed and marketed by the Company.
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FibroGen and its partner AstraZeneca yesterday announced that the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CARDAC) will hold an advisory committee (AdCom) meeting. The committee will be assessing roxadustat’s new drug application for market entry in the U.S in that meeting. The date for the AdCom meeting has not been confirmed by the FDA yet. Based on positive results from a global Phase 3 study involving more than 8,000 patients, the companies remain confident in the efficacy and safety profile of roxadustat.
In separate news also yesterday, the company announced the quarterly results for its fourth quarter 2020 financials.
Total revenue generated by the company in the fourth quarter of 2020 increased to $65.0 million from $8.0 million generated in the same quarter a year ago.
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The net loss incurred in the quarter was -$58.6 million, or -$0.64 per share, as compared to a net loss of $98.1 million, or -$1.12 per share a year ago while analysts were estimating a net loss of -$0.29 per share.