Gilead Sciences, Inc. (GILD - Free Report) announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets).
The company is seeking FDA approval for Descovy as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals, who are HIV-negative and at risk for HIV. While Descovy is already approved in combination with other antiretroviral agents for the treatment of HIV infection in patients weighing greater or equal to 25 kg, it is not indicated for PrEP yet.
A priority review voucher was submitted with the filing. Hence, the anticipated review time for the sNDA is expected to be six months.
The filing is based on the results of the phase III study, DISCOVER, which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women, who sexually engage with men at high-risk of contracting HIV infection. The results showed that Descovy achieved non-inferiority to Truvada in study participants, who were at substantial and sustained risk of HIV acquisition.
Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to boost its top line.
The stock has gained 8.3% in the year so far, lagging the industry's growth of 12.2%.
However, Gilead will have to generate substantial revenues from its HIV franchise to offset the HCV sales decline. This will be a challenging task for the company with stiff competition from the likes of GlaxoSmithKline (GSK - Free Report) in the HIV market.
The company is intending to foray into the non-alcoholic steatohepatitis (NASH) and inflammation markets with late-stage candidates, selonsertib and filgotinib, respectively. Gilead and partner Galapagos NV (GLPG - Free Report) announced encouraging interim safety information from four studies on filgotinib for the treatment of rheumatoid arthritis (RA).
However, the company recently announced the failure of its late-stage study on selonsertib, involving patients afflicted with compensated cirrhosis (F4) due to NASH.
Gilead also collaborated with Agneus (AGEN - Free Report) for the development and commercialization of up to five novel immuno-oncology therapies.
Gilead currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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