Gilead Sciences Inc. (NASDAQ: GILD) is the first company to cross the finish line for regulatory approval in the fight against the coronavirus. The firm’s antiviral drug Veklury (remdesivir) won approval from the U.S. Food and Drug Administration (FDA) on Thursday. It is the first treatment for COVID-19 to do so.
The approval of Veklury was supported by the FDA’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
Note that this approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1.
In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients within a certain weight limit.
Possible side effects include increased levels of liver enzymes, which may be a sign of liver injury and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating or shivering.
The FDA previously granted remdesivir a Fast Track designation, as well as a Priority Review designation.
The clinical trials assessing the safety and efficacy of Veklury in pediatric patient populations are ongoing.
Despite this approval, Gilead Sciences stock was still underperforming the broad markets, down about 7% year to date. Over the past 52 weeks, the share price is down closer to 9%.
Gilead Sciences stock traded up nearly 4% Friday morning, at $62.93 in a 52-week range of $59.65 to $85.97. The consensus price target is $78.42.