Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third quarter:
In May, Apellis Pharmaceuticals (APLS) secured U.S. approval for a drug called Empaveli to treat patients with a rare blood condition. The company is now looking to expand the use of the medicine to help people with geographic atrophy, an age-related condition that leads to the breakdown of the macula — an important part of a person’s retina. Results from twin Phase 3 clinical trials of Empaveli in patients with geographic atrophy are coming this quarter. With nearly 1 million people diagnosed with the eye disease, analysts predict the drug could bring in more than $1 billion in revenue annually for Apellis, if it wins an expanded label.
The Food and Drug Administration is convening an advisory panel on July 15, at which independent experts will be reviewing clinical data on roxadustat, an oral treatment for anemia developed by FibroGen (FGEN). The focus of the meeting is expected to fall mostly on roxadustat’s safety profile given FibroGen’s recent acknowledgment that certain cardiovascular safety analyses were altered.
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