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Wednesday evening, small-cap biotech company CytoDyn announced it had asked the U.S. Food and Drug Administration to grant the companys drug, Leronlimab, an emergency-use authorization to treat mild to moderate Covid-19 cases.
The request was made after the Vancouver, Wash.-based company announced promising data from a Phase 2 Leronlimab drug trial.
Thats good news. But following the ins and outs of therapy development can be difficult in any environment. Investors typically arent doctors. Covid-19 doesnt make it any easier. Investors these days are tracking many antiviral drugssome of which were designed for other virusesas well as several vaccine candidates.
Vaccines, of course, prevent people from contracting the virus. Antivirals treat the disease. Both are important to defeating Covid.
Leronlimab is an antiviral medication that was originally developed for HIV treatment. Its a humanized IgG4 monoclonal antibody that inhibits the ability for a virus to enter a cell. CytoDyn (ticker: CYDY) started testing Leronlimb on Covid-19 patients earlier in 2020.
What the company said Wednesday is that patients given shots of Leronlimb improved more than patients given placebos. The results were statistically significant.
CytoDyn is a $2.1 billion development-stage biotech without sales. Gilead Sciences (GILD) is an $85 billion biotech generating more than $22 billion in annual sales. Gileads Remdesivir is another antiviral medication that showed promise in clinical trials. The FDA granted Remdesivir emergency-use authorization to treat severe cases in May. Antiviral therapies are also in the works at Eli Lilly (LLY), GlaxoSmithKline (GSK), and Vir Biotechnology (VIR).
Regeneron Pharmaceuticals (REGN) is developing a cocktail of antibodies for Covid-19 treatment. Earlier this week, Canaccord Genuity analyst John Newman wrote that Phase 3 data for the cocktail could be ready later this year.
Later this year is also the time frame for data from important Phase 3 vaccine trials. Phase 3 is typically the last phase of clinical testing and is designed to demonstrate efficacy.
Russia made headlines earlier in the week announcing their vaccine was ready. But, in U.S. terms, their vaccine has just exited Phase 1 and 2 trials.
GlaxoSmithKline, Pfizer (PFE), Oxford University, Moderna (MRNA) and Novavax (NVAX) all have vaccine candidates in Phase 3 testing. It has been a while since those entities updated investors, but enrollment should be wrapped up soon. Each of those companiesand the universityis recruiting about 30,000 patients in the final trial.
Covid-19 health-care stocks have had a wild 2020. CytoDyn stock actually dropped 8.5% following the conference call. The stock is down 15% for the week, despite positive data. Still, shares have gained more than 300% year to date, far better than the comparable gains of the S&P 500 and Dow Jones Industrial Average over the same span.
The stocks mentioned above are up 465% year to date on average. Novavax is up the most at more than 3,200%. Glaxo is the weakest of the bunch, falling 12.3% year to date.
Corrections & Amplifications
CytoDyn is based in Vancouver, Wash. An earlier version of this article incorrectly said it was a Canadian company.
Write to Al Root at allen.root@dowjones.com
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