FibroGen Inc. (FGEN) stock prices were up 4.53% shortly after market trading commenced on August 20th, 2021. This brought the price per share up to USD$11.99 early on in the trading day.
FGEN Stock’s Denial by FDA
July 2021 saw the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S Food and Drug Administration deny submissions of roxadustat. Both AstraZeneca and FibroGen were denied applications for the approval of Roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD). The denial applies to both non-dialysis-dependent (NDD) patients, as well as dialysis-dependent (DD) patients.
FGEN Stock’s Partnership with AstraZeneca
FGEN stock is collaborating with AstraZeneca to develop and commercialize Roxadustat for the treatment of anemia related to CKD. The partnership is targeting markets in the United States, Australia and New Zealand, China, and Southeast Asia. Concurrently, the company is partnering with Astellas Pharma to develop and commercialize Roxadustat for the treatment of CKD-related anemia in Japan, Europe, the Middle East, and South Africa.
Chinese Approval of Roxadustat
With FGEN stock taking steps to facilitate the approval of Roxadustat by the FDA, the company is highly dependent on the eventual commercialization of the treatment. The company has been bolstered by the CRDAC’s request for another clinical trial, giving it reason to remain optimistic. The treatment has been approved by China’s National Medical Products Administration (NMPA). Resultingly, it has been marketed for the treatment of anemia in CKD patients as of August 2019. Hospital listings at the end of the second quarter of fiscal 2021 reported covering 81% of the CKD anemia market opportunity in China. This is comparable to the 74% reported in the prior quarter.
Scope of Market
This marks the continued growth of the treatment in China, the market penetration of which generated USD$92 million for AstraZeneca in the first half of 2021. Roxadustat is increasingly being adopted by healthcare providers in China, with Research and Markets expecting the CKD anemia market to grow by 3.4% annually. Forecasts predict global sales to reach USD$6.6 billion by 2029.
Future Outlook for FGEN Stock
The company reported a strong quarter and is poised to recover from the blow of the FDA’s denial of its submission for Roxadustat. FGEN stock is keen to accelerate the approval and eventual commercialization of its flagship treatment in the United States. Investors are hopeful that this will translate into strong organic growth over the long term.
