Gilead Sciences, Inc. Notches FDA Approval for Biktarvy in HIV-1


In a landmark advancement against the onslaught of AIDS, the FDA approved today a once-daily single tablet regimen (STR) of Gilead Sciences (NASDAQ:GILD), as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history. It’s also indicated to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of the approved drug.

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Gilead’s product, which will be branded as Biktarvy, does not cure HIV infection or AIDS.

Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B.

Gilead CEO John F. Milligan commented, “Gilead is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients […] We are pleased to offer Biktarvy, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with the most-prescribed dual-NRTI backbone in a once-daily single tablet regimen.”

Additional clinical trials of Biktarvy are ongoing, including a dedicated study in women, as well as a study in adolescents and children living with HIV. Gilead plans to present data from these studies at scientific conferences in 2018.

On the ratings front, Gilead stock has been the subject of a number of recent research reports. In a report released today, Maxim analyst Jason Kolbert assigned a Buy rating on GILD, with a price target of $94, which represents a potential upside of 18% from where the stock is currently trading. In addition, Citigroup’s Robyn Karnauskas assigned a Buy rating to the stock and has a price target of $105.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Robyn Karnauskas have a yearly average loss of 6.8% and a return of 5.3% respectively. Kolbert has a success rate of 35% and is ranked #4650 out of 4736 analysts, while Karnauskas has a success rate of 51% and is ranked #1108.

Sentiment on the street is mostly bullish on GILD stock. Out of 13 analysts who cover the stock, 7 suggest a Buy rating and 6 recommend to Hold the stock. The 12-month average price target assigned to the stock is $91.67, which represents a potential upside of 15% from where the stock is currently trading.