GILD Stock Jumps After Winning Accelerated FDA Approval For HDV Treatment

• Chronic HDV is considered the most severe form of viral hepatitis.
• Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA). 
• Gilead Sciences concluded the acquisition of Germany -based biotech firm Tubulis.

Gilead Sciences (GILD) share price gained nearly 3% on Friday and was set to record its best day in about three months after Federal regulators granted accelerated approval to Hepcludex, making it the first and only approved treatment in the U.S. for adults with chronic hepatitis delta virus infection. 

Chronic hepatitis delta, or HDV, only occurs as a co-infection in individuals who already carry the hepatitis B virus. It is associated with rapid progression to liver disease, liver failure, liver cancer and death. Health officials estimate that the disease affects between 40,000 and 80,000 Americans.

"Today's approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available," said Dr. Wendy Carter, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

Hepcludex, known chemically as bulevirtide-gmod, acts as a first-in-class entry inhibitor, blocking both HDV and hepatitis B from entering liver cells and disrupting the viral lifecycle. It is administered via a once-daily injection for adults who either do not have cirrhosis or have compensated cirrhosis, a state where the liver is scarred but still functional. 

"The approval of Hepcludex represents a historic milestone for people living with HDV in the United States," said Dr. Dietmar Berger, chief medical officer at Gilead Sciences in a statement. "This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need." 

In the U.S., HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people, Gilead said in a release citing studies. 

MYR301 study 

The FDA’s decision was heavily informed by data from a multi-center Phase 3 clinical trial, known as MYR301.

Participants were randomly assigned to immediate treatment with Hepcludex 8.5 mg once daily for 144 weeks or to delayed treatment with an observational period of 48 weeks followed by Hepcludex 8.5 mg once daily for 96 weeks.

Furthermore, data showed that the percentage of participants with completely undetectable viral levels climbed steadily from 20% at week 48 to 50% by week 144.

The FDA previously granted Hepcludex breakthrough therapy and orphan-drug designations to expedite its review. While newly approved in the U.S., a 2 mg dose of the drug has already been available in the European Economic Area and other global markets. 

GILD Retail View 

Retail sentiment on Stocktwits was ‘normal’ with ‘high’ message volumes. 

The stock has gained 29% over the past 12 months.

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