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Biotech Stocks Facing FDA Decision In October 2019

Gilead Sciences
Gilead Sciences

The FDA is slated to announce its decision on Gilead Sciences Inc.’s (GILD) request to expand the label of antiviral Descovy for pre-exposure prophylaxis to prevent HIV-1 infection in patients most at risk on October 5, 2019.

HIV-1 is responsible for the majority of HIV infections worldwide and is transmitted through direct contact with HIV-infected body fluids or during pregnancy.

Descovy is currently indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The drug is a combination pill of tenofovir alafenamide (TAF), marketed as Vemlidy, plus emtricitabine (FTC), marketed as Emtriva.

Currently, the only drug approved for HIV pre-exposure prophylaxis is Truvada, which is also from the stable of Gilead.

On August 7, 2019, the FDA panel voted 16–2 recommending Descovy for preexposure prophylaxis (PrEP) against HIV infection in men and transgender women who have sex with men. However, the panel voted 10 to 8 that there were not adequate data to recommend approval of a PrEP indication for Descovy for cisgender women.

Descovy brought in global annual sales of $1.58 billion in 2018 compared to $1.22 billion in 2017.

GILD closed Friday’s (Sep.27, 2019) trading at $62.90, down 0.63%.