Healthcare Roundup – FDA yanks emergency use authorization of Chembio COVID-19 blood test, Gilead readies pediatric study of remdesivir
FDA yanks emergency use authorization of Chembio COVID-19 blood test
Citing concerns with accuracy, the FDA has revoked the emergency use authorization of Chembio’s (NASDAQ:CEMI) DPP COVID-19 IgM/IgG System, its SARS-CoV-2 antibody test.
Data submitted by the company and results from an independent evaluation of the test showed a higher-than-expected rate of false results that was higher than the device’s labeling.
The FDA OK’d the emergency use of the test on April 15.
Shares down 51% premarket on average volume.
Gilead readies pediatric study of remdesivir
Gilead Sciences (GILD -1.1%) announces that enrollment will soon begin in an open-label Phase 2/3 clinical trial evaluating remdesivir in 50 children and young adults with moderate-to-severe COVID-19. The study will be conducted in the U.S. and Europe across 30 sites.
The primary objectives are safety and pharmacokinetics. Secondary endpoints include efficacy measures.
Moderna insiders cashing in after extended run-up
Unsurprisingly, Moderna (MRNA -1.1%) insiders have been bagging profits on shares and options after the extended rally that started in earnest in February as the COVID-19 pandemic emerged. Shares more than quadrupled since then, touching $87 on May 18, before retracing.
According to Nasdaq, there have been 67 sell transactions over the past three months representing ~15.5M shares, although this represents only 4.4% of shares outstanding as of March 31 (353.1M).
The company is in the middle of a neck-and-neck race to a COVID-19 vaccine. A Phase 3 study should launch next month. If positive, a vaccine may be available as early as Q4.
Innovation Pharma reports more “positive” COVID-related Brilacidin data
Nano cap Innovation Pharmaceuticals (OTCQB:IPIX +28.3%) announces new results from ongoing laboratory tests evaluating Brilacidin’s effects on the SARS-CoV-2 virus in cell cultures.
In a human lung epithelial cell line, Brilacidin reduced viral load by 95% and 97%, respectively, compared to control, at two therapeutic concentrations tested while being non-toxic to the cells.
The company says the new data reinforce previous testing, in VERO cells, where Brilacidin showed inhibition of 75% against SARS-CoV-2 compared to control.
Results, when completed, will be submitted for publication. Data generated to date supported a federal grant application filed last week by RBL, the testing laboratory, in collaboration with IPIX seeking funds to finance studies evaluating Brilacidin as a pan-coronavirus therapeutic.
It is in the process of manufacturing Brilacidin for intravenous dosing and will be seeking FDA guidance on a proposed COVID-19 clinical trial.
COVID-19 cases swell in 21 states
The COVID-19 pandemic continues to grow in 21 states, with Texas, Florida, and Arizona setting daily records for new cases.
The number of COVID-19 hospitalizations in Texas rose 11% in a single day, reaching a new high.
That’s the eighth new high in the Lone Star state in less than two weeks; hospitalizations are now up more than 84% since Memorial Day as Texas proceeds with its reopening plans.
At a press briefing yesterday, Governor Greg Abbott said the state has plenty of available hospital beds and the ability to boost capacity quickly if needed.
Florida had almost 2,800 new virus cases on Monday, the highest number of new and confirmed cases in a single day that state has seen, according to the Florida Department of Health.
Governor Ron DeSantis told reporters that the state will not shut down in response.
Eight states are seeing steady numbers of newly reported cases, while 21, including New York and New Jersey, are seeing a declining number of new cases.
To put the Texas hospitalization rate in context, that 2,581 hospitalizations represents only 0.009% of the state’s population.