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Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use

April 13, 2020 4:05 pm
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Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use

Gilead Sciences, Inc. (NASDAQ:GILD) announced publication Friday of data in the New England Journal of Medicine from a small cohort of COVID-19 patients who were treated with its remdesivir through compassionate use.

The Gilead Analysts

BofA Securities analyst Geoff Meacham maintained a Neutral rating on Gilead with a $75 price target.

Wells Fargo Securities analyst Jim Birchenough maintained an Overweight rating with an $87 price target. 

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Any Clinical Use Of Remdesivir Will Largely Be A Stopgap, BofA Says

Overall trends were positive, with 68% of the patients treated with Gilead's remdesivir experiencing clinical improvement, Meacham said in a Sunday note.

The data is encouraging from a clinical perspective given the limited treatment options for the new coronavirus, the analyst said. 

Yet the results also underline the challenges, with nearly one-third of patients failing to improve and a 13% fatality rate, he said. 

Meacham said he also sees the 10-day course of intravenous administration, which requires 30-60 minutes per dose, as a handicap.

The rate of adverse events was high, the analyst said. 

"Remdesivir may well have some efficacy against COVID-19, but with other more targeted modalities advancing (e.g., neutralizing antibodies and vaccines) and given these limitations, we expect any clinical use to largely be stop-gap."

Another reason for skepticism is the need to administer remdesivir early in the disease, he said. 

Meacham also raised questions about the overall small population of 61 patients, the lack of a control arm, the loss of eight patients in the analysis and unavailability of viral load data that would confirm antiviral activity.

The possibility of getting answers for all these questions is now remote, as a placebo-controlled Phase 3 severe study in China was discontinued due to low enrollment, the analyst said. 

Enrollment in the mild-to-moderate China study is still ongoing, and data from a Gilead-sponsored open-label study in severe disease is expected later in April, according to BofA. 

See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates

Wells Fargo Optimistic About Ongoing Randomized Studies

Gilead's overall results are highly encouraging for a critically ill population, with a relatively high rate of clinical improvement as well as improvement in the category of oxygen support and much lower mortality rates than are seen in studies, Birchenough said in a Monday note. 

The 13% mortality rate in the study compares favorably to the 22% rate reported for lopinavir/ritonavir, despite a much higher rate of ventilator dependence in the remdesivir study, as well as the 17% to 68% rate reported in other case studies, the analyst said. 

The results for remdesivir should improve with earlier use in less critically ill patients, he said, adding that he's optimistic regarding the prospects for ongoing randomized studies.

"With limited toxicity, beyond elevated liver enzymes in some patients, investigators characterized the results as representing the best currently available data, although noting limitations of small patient numbers and lack of control group."

Gilead shares were up 2.41% at $75.28 at the close Monday. 

Related Link: Morgan Stanley Downgrades Lilly On Valuation, Says Growth, Pipeline Potential Balanced By Stock Premium

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