Gilead Sciences, Inc. (GILD) Announces Submission of New Drug Application for Fixed-Dose Combination of Bictegravi


Gilead Sciences, Inc. (NASDAQ:GILDannounced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naïve adult patients and among virologically suppressed adult patients who switched regimens.

“We aim to simplify the management of HIV for a broad range of patients with this single tablet regimen that combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “This regulatory filing is a demonstration of Gilead’s ongoing commitment to bringing forward treatment innovations that have the potential to address the needs of patients and physicians.”

The NDA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir (50mg) among treatment-naïve patients and among virologically suppressed patients (HIV-1 RNA levels <50 copies/mL) switching from an existing antiretroviral regimen with dolutegravir. A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor.

Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.

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 last Friday at $64.7, up $0.58 or 0.90%. GILD has a 1-year high of $88.85 and a 1-year low of $63.88. The stock’s 50-day moving average is $65.98 and its 200-day moving average is $69.43.

On the ratings front, Gilead has been the subject of a number of recent research reports. In a report released today, Jefferies analyst Eun Yang reiterated a Buy rating on GILD, with a price target of $82, which implies an upside of 27% from current levels. Separately, on May 30, 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, Eun Yang and Gabrielle Zhou have a yearly average return of 0.8% and a loss of 13.3% respectively. Yang has a success rate of 46% and is ranked #2124 out of 4570 analysts, while Zhou has a success rate of 35% and is ranked #4393.

Sentiment on the street is mostly bullish on GILD stock. Out of 12 analysts who cover the stock, 9 suggest a Buy rating and 3 recommend to Hold the stock. The 12-month average price target assigned to the stock is $79.00, which implies an upside of 22% from current levels.

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.