Gilead’s Oral Epclusa Formulation Receives FDA Approval to Treat Hepatitis C in Children Aged 3 and Above

Gilead Sciences (GILD) has received approval from the U.S. Food and Drug Administration to expand the pediatric indication of Epclusa in children aged three and above for the treatment of chronic hepatitis C virus (HCV).

Chief Medical Officer of Gilead Sciences Merdad Parsey said, “Gilead remains steadfast in its commitment to supporting HCV elimination. Today’s decision by the FDA represents important progress in expanding more cure options for children with HCV.” (See Gilead stock analysis on TipRanks)

This approval is based on data from a Phase 2 study on 41 participants for a period of 12 weeks. The drug showed a cure rate of 83% in all patients. Additionally, Epclusa’s safety profile for children in the study was consistent with the results of clinical trials of the drug in adults.

Recently, Mizuho Securities analyst Salim Syed reiterated a Buy rating on the stock and $81 price target (16.9% upside potential).

Syed said, “Descovy is holding 45% share in the pre-exposure prophylaxis (PrEP) market and Gilead anticipates it will be able to hold share at this level as the market gets back to pre-COVID-19 levels.”

Based on 9 Buys and 6 Holds, consensus among analysts is a Moderate Buy. The GILD average analyst price target of $78.58 implies 13.4% upside potential.

Shares have gained about 15.3% so far this year.

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