Gilead to Expand Market with First COVID-19 Study Data

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Gilead Sciences Inc., whose COVID-19 treatment has whipped markets amid conflicting previous reports of its effectiveness, is expected to release the first results of a study sponsored by the investigational drug company.

Data from the first 400 critically ill coronavirus patients treated with remdesivir in an open study are expected before the end of next week. While not intended to provide a definitive answer on efficiency, the report is likely to again trigger wide swings in Gilead stocks and the market in general. Option prices show that investors expect a more than 9% change in the drug manufacturer’s stock price over the next week.

Leaked results from a study in China knocked down Gilead’s shares and the S&P 500 on Thursday, as investors placed their hopes on a treatment or vaccine. A week ago, the drug manufacturer’s inventory has increased the most since November 2012, pushing the US benchmark up after data from one of Gilead’s test sites was leaked to Stat, a medical news site.

The potential for an effective coronavirus drug has become essential for investors trying to assess the extent of the pandemic’s damage to the economy, with outages stalling activity in many places. According to Dennis DeBusschere, strategist at Evercore ISI, a cure or drug treatment is now the biggest swing factor for investor sentiment.

“The only thing that matters to the market is confidence in how the reopening will work,” DeBusschere said by phone on Friday. “The more effective the treatments, the higher the confidence, and vice versa. The Fed and the fiscal stimulus are secondary. “

The data to be released next week will not offer the same scientific rigor or assurance as that from studies in which patients are randomized to treatment and placebo and where doctors do not know which patient is receiving. The National Institute of Allergy and Infectious Diseases is conducting its own blinded placebo-controlled study of remdesivir. These results should arrive in May and will probably give a more definitive answer on the effectiveness of the treatment.

The first part of the company-sponsored study targets patients who have not been mechanically ventilated. Research suggests that more than two-thirds of patients who are put on respirators die before removing them.

Investors Should Research Remdesivir To Show About Only 10% Of Study Patients Die, About Half See “Significant Two Week Clinical Improvements / Oxygenation” And Three Times Reduction viral after about a week. , according to RBC analyst Brian Abrahams. Clinicians would also like to see “dose dependence signals suggesting potential activity” for remdesivir. The composition of the patient population will also need to be taken into account, as a patient’s risk factors are known to have some influence on how they will act, he said.

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Citi’s Mohit Bansal expects the trial to provide an overview of the duration of treatment required. If remdesivir appears to work after just five days instead of 10, “it could potentially double the treatment capacity,” said Bansal. Gilead’s manufacturing capacity is a concern because the drug is difficult to produce.

RBC and Citi have stated that remdesivir has a 50/50 chance of succeeding. Stocks could return to pre-pandemic levels of US $ 70 or less, while success could add up to US $ 26 to current trading.

Remdesivir “is not a quick fix; but it’s not a zero either, “said Umer Raffat, health care analyst at Evercore ISI, in a note on April 17. Gilead’s trial is expected to show interesting trends that would be “hard to interpret” without any arm of comparison, said Raffat.

Juliet Morrison, a virologist at Riverside at the University of California, expressed a similar sentiment. “We still don’t have the raw data, but that doesn’t seem impressive to me,” she said in a telephone interview after the release of the Chinese data. For diseases like COVID-19 driven by a patient’s own immune system, “antivirals are unlikely to work. And they will not be helpful in the severe stages of the disease when the virus is not the determining factor, “she said.

With so much information from so many different small studies, “some studies are changed halfway,” said Morrison. Gilead changed several test parameters several times.

“I wish I could be more positive. I want it to work, but I also don’t want us to bark the wrong tree because we are desperately looking for a cure, “said Morrison.

The lead investigator of a South Carolina remdesivir study site also took into account the first anecdotal reports of the effectiveness of remdesivir without a placebo comparison. “It’s like giving someone a rock and telling them it will keep the tigers away. If they don’t see tigers, it’s not necessarily because of the rock, “he said in a statement.



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