Gilead Gets FDA Approval for Veklury

Gilead Sciences (NASDAQ: GILD) announced on Friday that it was granted expedited approval by the U.S. Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Veklury® (remdesivir).

The drug is designed to treat non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19. Markedly, it has been approved by the FDA for pediatric emergency use as well. The approval includes non-hospitalized pediatric patients below 12 years of age.

Supporting Data

The regulator’s decision is based on the results from the PINETREE Phase 3 placebo-controlled trial. It included 562 participants to evaluate the efficacy and safety of a three-day course of Veklury. Results demonstrated a significant 87% reduction in risk compared with the placebo.

CEO Comments

Encouraged by the FDA approval, Gilead CEO Daniel O’Day said, “Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease.”

“While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID-19 antiviral, GS-5245 is now underway,” he added.

Wall Street’s Take

On January 13, Mizuho Securities analyst Salim Syed maintained a Buy rating and a price target of $81 (18.23% upside potential) on the stock. The analyst believes that management sounded positive about the growth and stability of the company through the decade.

In a note to investors, Syed said that management views a “stable or growing” HIV business between now and 2030 and beyond.

Additionally, management expects oncology to contribute one-third of its revenue by 2030 on a risk-adjusted basis.

Overall, Gilead has a Moderate Buy consensus rating based on an even split between Buys and Holds. The average Gilead price target of $77.31 suggests upside potential of 12.84% from the current price of $68.51.

Smart Score

Gilead scores a “Perfect 10” from TipRanks’ Smart Score rating system. This makes it one of TipRanks’ Top Stocks and implies that the stock has strong potential to outperform market expectations.

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