Ovation Science Inc. (CSE: OVAT)
Ovation Science: Better Drug Delivery for Better Results
Regeneron (NASDAQ:REGN) drops 2.4% and Sanofi (NASDAQ:SNY) slips 1.7% in after-hours trading after their Phase 3 trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation failed to meet its primary and key secondary goals.
The trial was testing Kevzara in addition to best supportive care compared with best supportive care alone (placebo).
Minor positive trends were observed in the primary pre-specified analysis group but didn’t reach statistical significance.
In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients.
The U.S.-based trial was halted, including in a second cohort of patients who received a higher dose of Kevzara (800 mg).
A separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing.
Previously: Regeneron and Sanofi’s Kevzara shows no clinical benefit in COVID-19 study (April 27)
“You don’t want to balance lives against the economy,” said infectious diseases expert Anthony Fauci said in an interview with the Journal of the American Medical Association.
“So let’s get public health to help us to get the economy open as opposed to two opposing forces,” he added.
With the U.S. reporting more than 50K new COVID-19 cases on Wednesday, its highest daily number so far, Fauci stresses that “we need to take very seriously because there’s so many implications of it.”
Yesterday, he said new COVID-19 cases could reach more than 100K per day if Americans don’t change their behavior. And on June 29, he called virus trends “disturbing.”
All told, there have been 2.72M confirmed COVID-19 cases in the U.S. and 128,496 deaths from the virus, according to the Johns Hopkins University Coronavirus Resource Center.
Some states have pulled back on reopening as virus cases surged such as Florida and Texas, which have closed down bars.
New York and New Jersey, where cases are stable, have decided to delay in-restaurant dining.
Moderna (NASDAQ:MRNA) has slid 4.8% after a Stat News report saying a trial of the company’s COVID-19 vaccine has been delayed.
The 30,000-patient Phase 3 study was set to begin July 9, but changes to the protocol are pushing back the expected start. It could still come in July as the company looks “close to being on target,” according to one investigator.
The delay is a potential hurdle in the company’s ambitious plan to have key data by Thanksgiving, Stat News notes.
For now, Pfizer (PFE +2.7%) and BioNTech plan to start a 30,000-patient study of their own later this month; AstraZeneca (AZN +0.6%) and Oxford will start a similar-size trial in August; and Johnson & Johnson (JNJ +0.4%) in September.
Florida is reporting a one-day record of 10,109 new cases of COVID-19 on Thursday. That’s a 6.4% rise in total cases vs. the seven-day average of 5.6%.
The S&P 500 is up 1.1%, off earlier highs inspired by the jump in nonfarm payrolls.
When speaking about today’s jobs numbers, President Trump said the government continues “to address the temporary hotspots in certain cities and counties”.
Yesterday, California Governor Gavin Newsom ordered the immediate closing of indoor operations for restaurants, wineries, movie theaters/family entertainment, zoos/museums, and cardrooms in 19 of the state’s counties ahead of July 4th.
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Teladoc Health (NYSE:TDOC) has completed its acquisition of Santa Barbara, California based InTouch Health, for consideration of ~$150M in cash and 4.6M common shares of Teladoc.
With the integration of InTouch’s telehealth capabilities, Teladoc will connect the care experience across in-patient, outpatient and home care settings.
The company is now the only global end-to-end partner spanning the full spectrum from acute visits and chronic conditions management to complex specialty care and remote surgery.