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FibroGen (FGEN) Meets Main Goal in Chemo-Induced Anemia Study

FibroGen (FGEN) announces positive top-line data from the study of its investigational candidate roxadustat, which is being evaluated to treat chemoth...

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FibroGen FGEN announced positive top-line data from the phase II WHITNEY study, which is evaluating roxadustat for the treatment of chemotherapy-induced anemia (CIA). The company partnered with AstraZeneca AZN for the development and commercialization of roxadustat across the United States.

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The study met its primary efficacy endpoint. Treatment with roxadustat demonstrated a maximum change in hemoglobin during the 16-week regimen from the baseline without red blood cell transfusion.

Despite this positive news, shares of the company declined 1.9% on Aug 25. In fact, the stock has plunged 68% so far this year compared with the industry’s decline of 11.7%.

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The WHITNEY study (n=92) evaluated the efficacy and safety of roxadustat for the treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies (solid tumors) and having a hemoglobin level at or below 10 g/dL. During the treatment period of 16 weeks, the patients received a dose of 2.0 mg/kg or 2.5 mg/kg of the drug, thrice a week. The company will announce the full data from the study at a medical meeting in the latter part of 2021.

CIA is one of the most common side effects of chemotherapy. Frequently undertreated, the anemia deteriorates both quality of life and efficacy of chemotherapy treatment. Moreover, the incidence and severity of CIA depends on a variety of factors including the type of cancer and the treatment, the type of chemotherapy, schedule and the intensity of therapy.

Per the press release, an estimated 30-90% of cancer patients is receiving chemotherapy develop anemia. In the United States, approximately 650,000 cancer patients undergo chemotherapy every year. It is anticipated that a potential approval and the commercialization of the drug for the given indication will generate impressive revenues for the company. FibroGen is also evaluating roxadustat to treat anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS).

We remind investors that last week, the company announced the European Commission’s approval of roxadustat to treat adult patients with symptomatic anemia associated with CKD. The drug will be sold in Europe under the brand name Evrenzo. The same also received a regulatory nod in China, Japan, Chile and South Korea for a similar indication.

Zacks Rank& Stocks to Consider

FibroGen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Regeneron Pharmaceuticals REGN and Vertex Pharmaceuticals VRTX, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see  the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.96 to $54.15 in the past 30 days. The same for 2022 has risen from $40.91 to $44.11 over the same period. The stock has rallied 38.5% in the year so far.

Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.24 to $13.13 over the same period.

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