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Biotech Stocks Facing FDA Decision In July 2021

FibroGen
FibroGen

A panel of outside experts on July 15, will recommend to the FDA whether or not to approve FibroGen Inc.(FGEN)/AstraZeneca Inc.’s (AZN) Roxadustat.

The companies are seeking approval of Roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.

Roxadustat, an oral medicine, is the first in a new class of medicines called HIF-PH inhibitors that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

Roxadustat is approved and launched in China and Japan for the treatment of anemia of CKD in patients on dialysis and not on dialysis.
The current stand-of-care erythropoiesis-stimulating agents such as Amgen's Epogen and Johnson & Johnson's (JNJ) Procrit are administered as injection. In 2020, the annual sales of Epogen were $598 million and that of Procrit were $552 million.

If approved in the U.S., Roxadustat could achieve peak sales of $719 million in 2025, according to SVB Leerink analyst Geoffrey Porges.

AstraZeneca and FibroGen are collaborating on the development and commercialization of Roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas, and in Australia and New Zealand, as well as Southeast Asia.

FGEN closed Wednesday’s (Jun.23, 2021) trading at $28.80, up 4.16%