FibroGen (NASDAQ:FGEN) stock is falling hard on Friday after the company received the results of a review for one of its drugs.
Those results come in the form of a vote from the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee. This group voted to not recommend roxadustat for approval by the FDA.
Roxadustat is FibroGen’s oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anemia due to chronic kidney disease (CKD) in adult patients. The FDA doesn’t have to follow the committee’s recommendation but typically does.
The Cardiovascular and Renal Drugs Advisory Committee came to its decision after reviewing data from a Phase 3 clinical trial with 8,000 patients. The decision to not recommend comes despite the drug being approved in China, Japan, Chile, and South Korea.
Enrique Conterno, CEO of FibroGen, said the following about the news sending FGEN stock lower today.
“While we are disappointed with today’s outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat.”
FGEN stock is seeing heavy trading today following the FDA news. As of this writing, more than 7 million shares of the stock have changed hands. That’s a heft increase compared to the company’s daily average trading volume of 1 million shares.
FGEN stock was down 44.3% as of Friday morning and is down 63.2% since the start of the year.
There’s other medical news that investors will want to know about today.
Fortunately, InvestorPlace has it all in one place for traders to access easily. That includes what to know about Moderna (NASDAQ:MRNA) as it prepares to join the S&P 500, why Biogen (NASDAQ:BIIB) was falling yesterday, and more. You can learn all about these topics by following the links below!
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.