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FibroGen's (FGEN) NDA for Roxadustat Accepted by the FDA

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FibroGen, Inc. FGEN announced that the FDA has accepted its new drug application (NDA) for roxadustat. The company is seeking approval of roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The application will be considered filed on Feb 18, 2020. The FDA has set an action date of Dec 20, 2020 for the same. 

Shares of the company have decreased 22.4% compared with the industry’s 0.3% decline in the past year.

We note that roxadustat has already been approved in China for treating anemiain CKD patients who are dialysis-dependent and NDD patients. It has also been approved in Japan for the treatment of dialysis patients with anemia of CKD.

Roxadustat — a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor — is being jointly developed by AstraZeneca Plc (AZN - Free Report) and FibroGen in the United States,China, and other markets in the Americas, Australia/New Zealand, as well as Southeast Asia.The drug is also jointly developed by FibroGen and Astellas in Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa. Astellas also plans to file a marketing authorization application with the European Medicines Agency in first-half 2020.

The NDA was supported by positive results from a phase III study including more than 8,000 patients. The filing of the roxadustat NDA has triggered a $50-million milestone payment from AstraZeneca to FibroGen.

Roxadustat is also in a phase II/III development in China for anemia associated with myelodysplastic syndromes (MDS), and phase II study for the treatment of chemotherapy-induced anemia in the United States.

Zacks Rank and Other Stocks to Consider

FibroGen currently has a Zacks Rank #2 (Buy).

Other top-ranked stocks from the healthcare space include Pacira Pharmaceuticals Inc. PCRX and KalVista Pharmaceuticals Inc. KALV, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pacira’s earnings per share estimates have increased from $1.53 to $1.55 for 2019 and from $2.11 to $2.19 for 2020 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 35.4%, on average.

KalVista’s loss per share estimates have narrowed from $1.83 to $1.63 for 2020 and from $2.78 to $2.74 for 2021 in the past 60 days. The company delivered a four-quarter positive earnings surprise of 30.02%, on average.

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