During Friday’s pre-market trading hours, FibroGen Inc. (FGEN) declined -36.03% to $15.89. The FibroGen stock gained 1.02% to close at $24.84 in last trading session. There was a price range between $24.65 and $25.36 for FGEN stock. The FGEN stock traded 2.15 million shares for the day, exceeding its 100-day average of 1.45 million shares. Shares of FGEN fell -0.84% over the last five days, while they fell -3.80% over the past month. FGEN stock fell after its therapy was recommended to be not approved bya committee at the US Food and Drug Administration (FDA).
Which FGEN drug is not approved by the FDA?
FibroGen The aim of FibroGen is to discover, develop, and commercialize new, first-in-class therapeutics. As a leader in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology, FGEN develops innovative medicines to treat unmet medical needs. FGEN is currently developing and marketing roxadustat for anemia of chronic kidney disease (CKD), which is an oral small molecule inhibitor of HIF prolyl hydroxylase activity. Additionally, Roxadustat is being tested for anemias associated with myelodysplastic syndromes (MDS) and chemotherapy-induced anemias (CIAs).
FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has recommended against the approval of roxadustat, according to FibroGen in a press release today.
- In making its recommendation, the Committee referred to data from more than 8,000 patients in a global Phase 3 program.
- FDA is not obligated to follow a committee’s vote, but it does consider the Committee’s recommendations when deciding what to approve.
- Roxadustat is approved to treat anemia of chronic kidney disease in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients in China, Japan, Chile, and South Korea.
- This product was also recommended as a positive medicine by the human medicine committee at the Committee for Medicinal Products for Human Use (CHMP) as well as by the EMA’s human medicine committee.
- The FDA has approved Roxadustat for review for anemia with chronic kidney disease.
- Treatment for anemia in chronic kidney disease patients could be transformed by Roxadustat .
- In response to the recommendation, FGEN expressed disappointment.
FGEN’s strategy going forward:
Upon Roxadustat’s submission of the New Drug Application, FGEN will work with the scientific evidence to support FDA approval. Also, FibroGen (FGEN) has appointed John Hunter, Ph.D., Chief Scientific Officer this week. As a global biopharmaceutical leader with more than 20 years of experience, Dr. Hunter will oversee FGEN’s research activities.
