Gilead Analyst: FDA's Remdesivir Label A Best Case Scenario For Biopharma

Gilead Sciences, Inc. GILD is the first company to receive full FDA approval for a COVID-19 treatment.

The Gilead Analyst: Raymond James analyst Steven Seedhouse has a Market Perform rating on Gilead shares. 

The Gilead Thesis: Veklury, generic name remdesivir, was already been branded as the standard-of-care prior to formal approval, Seedhouse said in a note. 

The label and approval are a best case scenario for Gilead relative to what could have occurred after the SOLIDARITY results for Veklury, the analyst said.

The SOLIDARITY trial initiated by the WHO, the results of which were made available last week,  showed that remdesivir has little or no effect on mortality or length of hospital stays among patients with respiratory disease, he said. 

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The label is as broad as possible given the available data, Seedhouse said.

The recommended dosing on the label suggests a five-day treatment course for patients not on invasive oxygen support. If they don't recover, the label calls for an additional five days of treatment, the analyst said.

For those invasively ventilated, a 10-day treatment course is recommended, he said. 

Seedhouse also noted that the label excludes negative trial results, including the results from the SOLIDARITY trial.

The approval appears to be full and not accelerated, the analyst said. 

The post-marketing requirements include a slew of studies, along with the due dates, which is reassuring, he said. 

How frequently Veklury will be used going forward is unclear, especially given the myriad post-marketing requirements, including a requirement to more rigorously look at viral shedding and viral load in all samples collected and submit to FDA, according to Raymond James. 

GILD Price Action: At last check, Gilead shares were trading up 1.1% to $61.33.

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Photo coutesy of Gilead.