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Friday, May 8, 2020

DENTSPLY SIRONA EPS beats by $0.08, beats on revenue

DENTSPLY SIRONA (NASDAQ:XRAY): Q1 Non-GAAP EPS of $0.43 beats by $0.08; GAAP EPS of -$0.63 misses by $0.83.
Revenue of $874.3M (-7.6% Y/Y) beats by $1.3M.
https://seekingalpha.com/news/3572001-dentsply-sirona-eps-beats-0_08-beats-on-revenue

66% of NYS coronavirus hospitalizations are people staying at home

  • A study of hospitals last week found that of 1,000 patients, 66 percent were people staying at home
  • 73% of the new hospitalizations were people aged 51 and over and 96% had underlying health conditions
  • Most were in Manhattan – 21% – but 18% of the new hospitalizations were in Long Island
  • In New York City, 90% of those who answered said they had not been taking public transport 
  • Cuomo said it showed that the new infections were down to ‘personal behavior’ like not wearing masks or not hand washing enough 
  • It prompts the question of whether lockdown even works or is necessary 
  • Deaths, hospitalizations and intubations are all down but the state remains in lockdown until May 15 
  • Cuomo said he is ‘vindicated’ by the states that are seeing numbers continue to rise throughout reopening 
  • There are now 19,877 deaths in New York state and more than 321,000 cases of the virus 
  • Across America, there have been more than 1million cases and 72,000 deaths
  • Recent data shows that while New York’s numbers are decreasing, the rest of America’s are on the rise  
The majority of people who are still being hospitalized with the coronavirus across the state of New York are staying at home and are not essential workers, new data has revealed, prompting the questions of whether or not lockdown even works or for how much longer it will be necessary.
In a study of some 1,000 new patients admitted to New York hospitals over the last week, 66 percent were staying at home and 18 percent had come from nursing homes, meaning they either became infected by going out to get groceries or other essential items, or from seeing people outside of work.
Gov. Cuomo said they were clearly becoming infected as a result of personal behavior, something that can’t be controlled by his lock-down.
https://www.dailymail.co.uk/news/article-8293417/66-New-York-coronavirus-hospitalizations-people-staying-HOME.html?ito=amp_twitter_share-top

RedHill Bio on go with mid-stage study of opaganib in COVID-19

The FDA has signed off on RedHill Biopharma’s (NASDAQ:RDHL) IND for a 40-subject Phase 2a clinical trial evaluating Yeliva (opaganib) in patients with moderate-to-severe COVID-19 infection.
The primary endpoint is the reduction in total oxygen requirement up to day 14.
The company says the study is not powered for statistical significance.
Opaganib is an orally administered inhibitor of an enzyme called sphingosine kinase-2 (SK2) that blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer growth and pathological inflammation.
https://seekingalpha.com/news/3572088-redhill-bio-on-go-mid-stage-study-of-opaganib-in-covidminus-19

Herbalife nears settlement with feds over China activities

Herbalife Nutrition (NYSE:HLF) discloses (10-Q, page 21) that it has reached an understanding in principle with the SEC and Department of Justice (DOJ) to settle their investigation into its compliance with the Foreign Corrupt Practices Act (FCPA) in China during the period 2006 – 2016.
Pursuant to the implementation of its own remedial measures, including replacing certain employees and beefing up its policies and procedures there, and its continued cooperation in the matter, the company would enter into an administrative resolution with the SEC and a deferred prosecution agreement (DPA) with the DOJ under which the latter would defer criminal prosecution for three years related to a conspiracy to violate certain FCPA provisions.
If the company remains in compliance with the DPA for the three-year period, the deferred charge will be dismissed with prejudice after it pays a total of $123M in penalties, disgorgement and prejudgment interest to the SEC and DOJ.
The parties are still negotiating the final details of the settlement documentation.
Shares up 13% premarket on light volume after its Q1 earnings beat.
https://seekingalpha.com/news/3572169-herbalife-nears-settlement-feds-over-china-activities

Cytokinetics’ omecamtiv mecarbil Fast Track’d for heart failure

Cytokinetics (NASDAQ:CYTK) and exclusive licensee Amgen (NASDAQ:AMGN) announce that the FDA has designated omecamtiv mecarbil for Fast Track review for the potential treatment of heart failure patients with reduced ejection fraction.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
A large-scale Phase 3 clinical trial, GALACTIC-HF, is in process with topline results expected in Q4.
Omecamtiv mecarbil is a cardiac myosin activator. Myosin is a protein in heart muscle that is responsible for converting chemical energy into the mechanical energy that results in a heartbeat. Cardiac myosin activators increase systolic ejection time which results in an increase in cardiac contractility and more oxygen-efficient cardiac function.

Sorrento teams up with Mount Sinai to develop COVID-19 treatment

Sorrento Therapeutics (SRNE +9.1%) has agreed to co-develop an antibody cocktail called COVI-SHIELD for the potential treatment of COVID-19 with Mount Sinai Health System.
COVI-SHIELD will consist of antibodies identified in plasma of ~15K patients who have recovered from the respiratory infection that was screened with a Mt. Sinai-developed test. Three antibodies will be used that bind to three unique regions of the SARS-CoV-2 spike protein, thereby interfering with its ability to infect healthy cells.
The company says the therapy is designed to be administered as often as necessary and to provide antiviral protection for up to two months.
https://seekingalpha.com/news/3572225-sorrento-teams-up-mount-sinai-to-develop-covidminus-19-treatment

Opko reference lab unit launches COVID-19 antibody screening in NY

OPKO Health (OPK +7.9%) unit BioReference Laboratories, in partnership with New York City Health and Hospital Corporation, launches blood screening for COVID-19 antibodies at five locations across all five boroughs.
Initial testing, for epidemiology purposes, will be performed for 140K residents. More testing sites will open in the coming weeks.
https://seekingalpha.com/news/3572217-opko-reference-lab-unit-launches-covidminus-19-antibody-screening-in-ny