RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
“As far as I know, a vaccine against a new coronavirus infection has been registered this morning, for the first time in the world,” Russian President Vladimir Putin declared, according to RIA Novosti.
“I know that it works quite effectively, forms a stable immunity and, I repeat, has passed all the necessary checks.”
He added that one of his daughters was vaccinated against the coronavirus and stressed that “many people do not have any external manifestations at all” or temperature after immunization (that’s despite Phase 3 trials that normally last for months and involve thousands of people).
“I hope that we will be able to begin in the near future the mass production of this drug. Whoever wants to, could take advantage of the developments and achievements of our specialists.”
At the end of July, the WHO said that there were 26 candidate vaccines in the clinical evaluation stage, including one registered in Russia that was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology.
Related tickers: Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX), Novavax (NASDAQ:NVAX), Inovio Pharmaceuticals (NASDAQ:INO), Moderna (NASDAQ:MRNA), AstraZeneca (NYSE:AZN), Dynavax (NASDAQ:DVAX), GlaxoSmithKline (NYSE:GSK), iBio (NYSEMKT:IBIO), Altimmune (NASDAQ:ALT) and VBI Vaccines (NASDAQ:VBIV).
Health Canada approves Bausch Health Companies (NYSE:BHC) unit Bausch + Lomb’s Ultra One Day daily disposable silicone hydrogel contact lens.
The company says the next-generation contact lens features the Advanced MoistureSeal and ComfortFeel technologies that provide a complete design of high oxygen, low modulus, easy handling, UV blocking and High Definition Optics.
The product will be available at select Canadian practitioners next quarter. Full national launch will commence in Q1 2021.
Shares up 1% premarket on light volume.
MyoKardia (NASDAQ:MYOK) +1.3% premarket, has announced a license agreement with LianBio, for the development and commercialization of its lead drug candidate, mavacamten for hypertrophic cardiomyopathy (HCM) in China, and other Asian territories.
HCM is an inherited disorder characterized by abnormal thickening of heart muscle leading to compromised cardiac function.
MyoKardia will receive an equity stake in Lian Cardiovascular, LianBio’s subsidiary and its CEO Tassos Gianakakos, will be appointed to LianBio’s Board of Directors.
Along with the equity position, MyoKardia will receive $40M, and may be eligible to milestone payments of up to $147.5M, as well as tiered double-digit sales-based royalties.
Mavacamten is an orally available small molecule designed to reduce left ventricular contractility by modulating the function of cardiac myosin, the protein that drives heart muscle contraction.
CytoDyn (OTCQB:CYDY -1.9%) reports, what it says, are “clinically significant” results from its Phase 2 clinical trial evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms.
The primary endpoint was the proportion of patients showing clinical improvement, as determined by the change in total clinical symptom score (TCSS), at day 14 compared to placebo, the results of which are not reported.
Instead, it announces day 3 results in a subgroup of patients with a TCSS of at least 4. 90% of patients in this group reported improvements compared to 71% in the placebo arm, a separation that is not indicated to be statistically significant.
One secondary endpoint, the change from baseline in National Early Warning Score 2 (NEWS2), which measures seven clinical parameters such as respiration rate and oxygen saturation, was met. At day 14, 50% of treated patients showed improvement compared to 20% in the control group (p=0.0223).
No data are provided on the other 11 secondary endpoints.
No safety signals were observed.
Management will host a conference call tomorrow, August 12, at 4:00 pm ET to discuss the results.
Shares of CytDyn are currently dipping below their 50-day moving average.
Moderna (NASDAQ:MRNA) has jumped 10.3% after hours following the news that it has a supply agreement with the U.S. government for an initial 100M doses of its COVID-19 vaccine.
The award covers up to $1.525B for the initial doses of mRNA-1273; it contains an option for the government to buy up to an additional 400M doses.
The deal contains incentives for timely delivery of the vaccine.
Combined with the previous award from BARDA of $955M, the announcement brings government commitments for mRNA-1273 up to $2.48B.
