Kroger expands COVID-19 testing for employees

With its continuing role as a full-staffed essential business, Kroger (KR +0.1%) says it is making free COVID-19 testing available to frontline employees based on symptoms and medical need.

Tests will be a combination of self-administered kits and the company’s public drive-thru testing sites. Kroger Health’s expansion to test more associates is in addition to the COVID-19 testing the company has already been supporting in areas with high incident rates.

Source: Press Release

https://seekingalpha.com/news/3568260-kroger-expands-covidminus-19-testing-for-employees

Cel-Sci almost there with late-stage Multikine study

CEL-SCI (CVM -0.7%) announces that its Phase 3 clinical trial evaluating immunotherapy Multikine (leukocyte interleukin injection) in head and neck cancer patients has reached the fatality threshold (298 deaths) allowing for database lock and final analysis to be completed.

The primary endpoint is overall survival at year 3 compared to standard-of-care surgical resection followed by radiation therapy or radiochemotherapy.

https://seekingalpha.com/news/3568256-cel-sci-almost-late-stage-multikine-study

Marinus Pharma updates business; shares down

Marinus Pharmaceuticals (NASDAQ:MRNS) provides an update on its clinical development activities.

Status Epilepticus: The company announces constructive end-of-Phase 2 meeting with the FDA.

Patient enrollment is expected to begin in Q3 with topline data expected in H1 2022.

CDKL5 Deficiency Disorder: Enrollment has been completed in Phase 3 Marigold Study. The company remains on-track to report top‑line data in Q3 with no expected material delays due to COVID-19. Marinus has begun preparations for an NDA filing.

Tuberous Sclerosis Complex: Marinus intends to start screening patients in a Phase 2 trial this quarter with top line data expected in Q1 2021.

PCDH19 Related Epilepsy (PCDH19-RE): Marinus will transition the ongoing Phase 3 Violet Study to a proof-of-concept (POC) trial evaluating allopregnanolone sulfate as a biomarker in patients with a confirmed PCDH19 mutation.

The company has decided to limit trial enrollment and announce results of this POC trial in H1 2021.

As on March 31, 2020, the Company had cash and cash equivalents and investments totaling $77.8M compared to $91.7M on December 31, 2019.

https://seekingalpha.com/news/3568227-marinus-pharma-updates-business-shares-down-7-premarket

Gilead’s remdesivir worth $4,500 per patient – ICER

Gilead Sciences (NASDAQ:GILD) perks up 1% premarket on increased volume on the heels of initial analyses of the cost/benefit of remdesivir for the treatment of COVID-19 by the non-profit Institute for Clinical and Economic Review (ICER).

ICER constructed two models, one estimating cost-recovery pricing ($9.32/10-day course of treatment) and one its cost-effectiveness, estimated at ~$4,500 per course.

The cost-effectiveness model is based on the findings from the Adaptive COVID-19 Treatment Trial (ACTT) and includes the drug’s benefits on time-to-improvement and mortality, although the latter remains uncertain since the effect was not statistically significant in the study.

ICER emphasizes a threshold price of $50K per incremental quality-adjusted life year (and equal value of a life-year gained) in order to allow for the uncertainty and accommodate affordability for immediate broad use.

The company has committed to donate its entire stock of 1.5M doses due to the intense need. In an interview yesterday on CBS, CEO Dan O’Day said remdesivir should be available to doctor and patients this week. The company expects to manufacture 1M courses by year-end.

https://seekingalpha.com/news/3568221-gileads-remdesivir-worth-4500-per-patient-icer

Lockdown sparks global yoga craze, digital health survey shows

Digital health firm Withings has used its technology to produce a read-out of how COVID-19 lockdowns have affected the health of its users, showing a smaller than expected increase in weight, a global yoga craze and an increase in exercise in some areas of the US.
Overall results showed that while the changes to routine had caused some people to gain weight and cut back on exercise, the effects of isolation were not as drastic as some people feared. 
Results from the survey showed that in the US only 37% of people have gained more than a pound, with the average gain at only .21 pounds (0.95 kgs).

Other countries have seen similar weight gain trends of people gaining around half a pound or less during isolation. 
In the UK the figure was .16 kgs, in Germany the average person gained .189 kgs, in China the figure was .25 kgs, and in Italy the average gain was .195 kgs. 
In France, the lockdown has had the smallest impact on weight, where the average person has only gained .084 kgs. 
Withings said that research has not revealed why this has happened – but it suggested that home-cooked meals are healthier because they cause people to eat more nutritious foods and take in fewer calories. 
Results also showed that in the US people have only decreased their daily steps by an average of 7% during isolation, compared with 12% globally. 
But findings varied from state to state, with New York seeing the largest decrease in daily steps of 22%, where lockdown restrictions are the toughest. 
In some states, the number of steps actually increased, up by 16% in Indiana, and by 11% in Connecticut. In Ohio and Michigan the number of steps increased by 6% and Louisiana also saw the number of steps increase by 4%.
In the UK the steps taken were down by 8%, and the tough lockdown in China had the biggest impact with steps decreasing by over half (56%) in Hubei, where the pandemic first originated. 
There has also been a global surge in yoga, which saw a 42% increase in popularity, hiking (up 34%), indoor cycling (a 19% increase) and running (an 18% increase). 
Sleep patterns have been disturbed, however, with those in America going to bed 11 minutes later than usual and waking up almost 26 minutes later than usual. 
The country that gained the least weight also got the most sleep, where people had an average 20 minutes and 40 seconds more sleep each night. 
This reinforced findings by Withings’ predecessor Nokia that people who sleep less are more likely to be overweight or obese. 

Lockdown sparks global yoga craze, digital health survey shows

Lilly teams up with Junshi Bio to develop COVID-19 treatments

Eli Lilly (NYSE:LLY) inks an agreement with Shanghai-based Junshi Biosciences to co-develop therapeutics antibodies for the potential treatment and prevention of COVID-19.

Junshi’s lead program appears to be JS016, a fully human recombinant monoclonal neutralizing antibody that binds to the SARS-CoV-2 spike protein receptor-binding domain, effectively blocking the coronavirus’ ability to bind to the ACE2 receptor on the surface of healthy cells (binding to ACE2 is the first step in the infection process).

Under the terms of the deal, Lilly will receive an exclusive license to develop, manufacture and distribute products outside of Greater China where Junshi will retain full rights.

Lilly plans to file an IND in the U.S. this quarter. Junshi is in talks with China’s National Medical Products Administration with the aim of starting clinical studies there.

https://seekingalpha.com/news/3568205-lilly-teams-up-junshi-bio-to-develop-covidminus-19-treatments

EMA grants PRIME designation to Acceleron’s sotatercept

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Acceleron Pharma’s (NASDAQ:XLRN) sotatercept for the treatment of patients with pulmonary arterial hypertension.

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

Sotatercept is an investigational therapy that is not approved for any use in any country.

https://seekingalpha.com/news/3568197-ema-grants-prime-designation-to-accelerons-sotatercept