Healthcare Roundup – T2 Biosystems launches COVID-19 molecular diagnostic test, CytoDyn down 32%
T2 Biosystems launches COVID-19 molecular diagnostic test in U.S.
T2 Biosystems has completed the validation of its T2SARS-CoV-2 Panel, its molecular test for COVID-19. Commercial launch is underway under emergency use authorization
The T2SARS-CoV-2 Panel runs on the Company’s T2Dx Instrument, an automated, random access system capable of performing seven tests simultaneously. Provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample.
Additionally, the company announced interim Q2 earnings and estimates revenue in the range of $2.4M-2.6M, compared to $1.8M in the prior year period.
At the end of the period, expects cash and cash equivalents of ~$36.5M.
(NASDAQ:TTOO) shares is up 33.9% to $1.70 in AH
CytoDyn down 32% on bearish Citron report
CytoDyn (OTCQB:CYDY -32.3%) is under pressure on more than a 6x surge in volume on the heels of a critical report from short seller Citron Research who regards the stock as a “big joke” about its claim to have developed a cure for COVID-19 with “zero” data related to over-hyped leronlimab.
Before today’s action, the stock had rallied 186% since June 17.
FDA guides on COVID-19 vaccine approval criteria
The FDA has released guidance on its standards for approving a COVID-19 vaccine, including a requirement that it must demonstrate that it is at least 50% more effective than placebo (a low bar compared to vaccines for other infectious diseases).
The agency says it will not approve any candidate unless safety and efficacy have been clearly shown in a clinical study, an obvious criterion, nor if the vaccine simply leads to antibodies in the bloodstream (due to the uncertainty of knowing what level of antibodies confer immunity against the SARS-Cov-2 virus).
It will also require a vaccine maker to conduct further safety monitoring post approval and will recommend following all vaccinated people for a year.
The FDA has drawn criticism over its quick approvals allowing the emergency use of diagnostic tests and certain drugs during the pandemic. After a number of the tests were found to be poor performers, it tightened its review process and rescinded EUA on some assays. It OK’d the emergency use of malaria drugs chloroquine and hydroxychloroquine then backtracked after neither proved effective in treating the respiratory infection.
National mask mandate could save GDP from a 5% cut, Goldman says
A national mandate to wear face masks could save the U.S. economy from additional lockdowns that would knock 5% off of GDP, according to a Goldman Sachs note.
Goldman Chief Economist Jan Hatzius and his team found that the link between face masks and COVID-19 health and economic outcomes is significant.
“We find that face masks are associated with significantly better coronavirus outcomes,” Hatzius wrote.
According to Goldman’s baseline estimate, a national mandate could increase the percentage of people wearing masks by 15 percentage points and cut the daily growth rate of confirmed cases by 1.0 percentage point to 0.6%.
Based on the economic effects of earlier lockdowns, the Goldman economists estimate that a face mask mandate could potentially avert lockdowns that would otherwise cuts almost 5% from GDP.
“If a face mask mandate meaningfully lowers coronavirus infections, it could be valuable not only from a public health perspective but also from an economic perspective because it could substitute for renewed lockdowns that would otherwise hit GDP,” Hatzius wrote.
Apparently, Evercore ISI sees the economic benefit of wearing face masks as well, issuing a note entitled: “Wear a mask if you want to see bank buybacks again.”
Inovio COVID-19 vaccine shows 94% response rate in early-stage study
Inovio Pharmaceuticals (NASDAQ:INO) announces preliminary data from a Phase 1 clinical trial evaluating COVID-19 DNA vaccine candidate INO-4800 in 40 healthy adult volunteers aged 18 – 50.
Each participant received 1 mg or 2 mg doses four weeks apart, each administered with the company’s Cellectra 2000 device.
94% (n=34/36) showed overall immunological responses based on data assessing humoral (binding and neutralizing) and T cell immune responses. Three participants were excluded from the immune analyses due to testing positive for COVID-19 antibodies at study entry and one discontinued for reasons unrelated to safety or tolerability.
The full dataset will be submitted for publication.
It has expanded the Phase 1 study to include older participants.
The company says INO-4800, selected to participate in an Operation Warp Speed-connected non-human primate challenge study, is the only nucleic acid-based vaccine that is room temperature-stable and does not need to be frozen during storage or transport.
A Phase 2/3 trial should launch this summer.
Shares down 10% premarket on robust volume in what looks like “sell on the news” behavior considering the stock’s 107% rally since June 22.