Last Friday, the FDA granted emergency use authorization (EUA) to Gilead Sciences, Inc. (NASDAQ:GILD) remdesivir to treat patients hospitalized with COVID19. The EUA approval came within days after Gilead and NIH scientists released clinical study results demonstrating the statistical significance of remdesivir treatment versus a placebo group.
With a market cap of $100 billion and valued largely on its HIV and hepatitis C drugs, the remdesivir announcement merely nudged Gilead’s shares higher. At the same time, smaller companies are seeing their shares soar as they receive government grants and support to pursue coronavirus treatments, or they repurpose existing drug programs to attack the pandemic. Among them: Arcturus Therapeutics Holdings (NASDAQ:ARCT), Novavax, Inc. (NASDAQ:NVAX) and Cytodyn Inc (OOTC:CYDY).
Shares of Arcturus, which SanaCurrents covered in March, closed at $40.86 per share on Friday, compared to $12.08 per share at the time of the March 20 report. Arcturus started last week in the $27-28 per share range. It then announced positive preclinical data for the COVID19 vaccine candidate it is developing with investigators aligned with Duke University-Singapore National University.
Novavax likewise is attempting to develop a COVID19 vaccine candidate. On April 8, Novavax said it had launched a novel coronavirus candidate with its nanoparticle technology and will initiate a human trial in mid-May. Novavax’s stock hit a high of $23.80 per share on April 20 after starting the year at $4.44 per share.
OTC-listed CytoDyn had been developing therapeutics for HIV, stroke recovery, multiple sclerosis and Parkinson’s disease by targeting the CCR5 receptor. The company’s lead drug, leronlimab, is a CCR5 antagonist. The company claims leronlimab, is a new class of HIV/AIDS therapeutic that protects healthy cells from viral infection. Gilead’s cocktail of drugs, which remains the current standard of care for HIV, waits until the virus enters the cell and begins replicating before it attacks the virus. CytoDyn has asserted leronlimab is safer but leronlimab has yet to make a dent in HIV prescriptions.
For Covid19, CytoDyn claims leronlimab will calm the cytokine storm of critically ill patients, thereby enabling faster recovery of respiratory function. The company started working on use of leronlimab in January with a China-based partner, then applied for Breakthrough Therapy designation, and subsequently started late-stage clinical trials in COVID19 patients. The company’s stock closed at $3.90 on May 1 after starting the year at $0.97 per share.
While the efforts of all three companies potentially can address and help alleviate the pandemic, it remains uncertain whether the companies can maintain their skyrocketing valuations during the next 12 months. A few vaccine and therapy companies may race ahead of competitors, but scale matters in tackling the coronavirus. Even if their therapies prove successful in the clinic, each of these companies likely will have to monetize or partner their drugs or vaccines to achieve full value.
SanaCurrents is a premium newsletter that has been offering its Premium service to GeoInvesting Members at a special rate. SanaCurrents assigns likelihoods of favorable FDA decisions or data releases (catalysts) surrounding biotech product development initiatives. Biotech expert Bill Langbein, along with his partner Philip Greyling, apply a host of qualitative and quantitative factors to support their rankings and their purchase of shares before dates of when FDA decisions or the release of important data. To date, SanaCurrents has written 64 reports, now archived at geoinvesting.com.