Gilead Sciences, Inc.’s HIV-1 Treatment Granted Priority Review


Gilead Sciences, Inc. (NASDAQ:GILDannounced that the FDA has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed the NDA for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.

The NDA is supported by data from four Phase 3 studies that evaluated the fixed-dose combination among treatment-naïve patients and among virologically suppressed patients. A marketing application for BIC/FTC/TAF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) in July. Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.

Shares of Gilead Sciences closed today at $72.70, down $1.20 or -1.62%. GILD has a 1-year high of $82.10 and a 1-year low of $63.76. The stock’s 50-day moving average is $72.16 and its 200-day moving average is $68.73.

On the ratings front, GILD has been the subject of a number of recent research reports. In a report issued on July 27, BMO analyst Ian Somaiya reiterated a Hold rating on GILD, with a price target of $82, which implies an upside of 12% from current levels. Separately, on the same day, Maxim’s Gabrielle Zhou reiterated a Hold rating on the stock.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ian Somaiya and Gabrielle Zhou have a yearly average return of 12.7% and 5.9% respectively. Somaiya has a success rate of 60% and is ranked #267 out of 4628 analysts, while Zhou has a success rate of 38% and is ranked #1506.

Overall, 3 research analysts have assigned a Hold rating, while 10 analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $85.50 which is 16% above where the stock opened today.

Gilead Sciences, Inc. is a biopharmaceutical company, which discovers, develops and commercializes therapeutics for unmet medical need. It focuses on human immunodeficiency virus and liver diseases, such as chronic hepatitis C virus infection & chronic hepatitis B virus infection, hematology & oncology, and cardiovascular & inflammation as well as respiratory diseases. The company’s products include Descovy, Odefsey, Genvoya, Stribild, Complera, Atripla, Truvada, Viread, Emtriva, Tybost, Vitekta, Vemlidy, Epclusa, Harvoni, Sovaldi, Viread, Hepsera, Zydelig, Letairis, Ranexa, Lexiscan, Cayston, Tamiflu, AmBisome and Macugen.