Moderna Zika vaccine shows promising action in early-stage study

Ahead of its Vaccines Day event today, Moderna (NASDAQ:MRNA) reports positive results from a Phase 1 study of its Zika vaccine candidate mRNA-1893.

Preliminary results for the 10 µg and 30 µg dose levels showed seroconversion (antibodies develop and are detectable) rates of 94% and 100%, respectively, while being well-tolerated.

The NIH-led Phase 1 study of its COVID-19 vaccine candidate, mRNA-1273, remains on track with enrollment at the highest dose.

The company says its prophylactic vaccines have demonstrated immunogenicity against all eight viruses targeted thus far.

It has nine candidates in development for RSV (older adults and young children), human metapneumovirus and parainfluenza virus type 3, coronavirus, influenza H7N9, CMV, Zika and Epstein-Barr.

It has generated positive Phase 1 data on seven candidates (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). The CMV vaccine candidate is currently being tested in a Phase 2 dose-confirmation trial.

https://seekingalpha.com/news/3560431-moderna-zika-vaccine-shows-promising-action-in-early-stage-study

Cytokinetics suspends enrollment in clinical studies amid COVID-19

Cytokinetics (NASDAQ:CYTK) provides clinical updates in response to COVID-19 pandemic.

The company and Amgen have agreed to temporarily suspend enrollment in METEORIC-HF, Phase 1 study of AMG 594 and REDWOOD-HCM to protect the safety and health of clinical trial participants and healthcare professionals.

The Data Monitoring Committee recommended that GALACTIC-HF continue without changes to its conduct. An estimated study completion date is August 7, with results expected in Q4.

The company is on track relating to the advancement of reldesemtiv to a Phase 3 trial in patients with ALS.

Cytokinetics ended 2019 with cash, cash equivalents and investments totaling $267.7M.

The company plans to provide further updates together with its Q1 financial results in May.

https://seekingalpha.com/news/3560435-cytokinetics-suspends-enrollment-in-clinical-studies-amid-covidminus-19-shares-down-7

Can-Fite to hold investor call on April 16

Can-Fite BioPharma (NYSEMKT:CANF) will conduct a conference call with investors to review the results of its Phase II exploratory NAFLD/NASH study with Namodenoson which achieved its primary and secondary efficacy endpoints, while showing continued safety.
Shares closed down 7%.
https://seekingalpha.com/news/3560462-can-fite-to-hold-investor-call-on-april-16-shares-down-5-premarket

Madrigal Pharma up 13% on positive data on NASH drug resmetirom

Thinly traded Madrigal Pharmaceuticals (NASDAQ:MDGL) is up 13% premarket on light volume on the heels of its announcement of new data from a Phase 2 clinical trial evaluating resmetirom (MGL-3196) in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Once-daily oral treatment of 80 mg or 100 mg of resmetirom (doses being tested in Phase 3) resulted in 50% and more than 60% reductions, respectively, in liver fat per new analyses of Phase 2 data. 60% of treated patients experienced reductions in fibrosis.

The company says its two Phase 3s, MAESTRO-NASH and MAESTRO-NAFLD-1, are continuing without protocol changes. Guidance from regulators has allowed for more flexible processes at trial sites amid COVID-19. New screening has slowed down but disruptions have been minimal for trial participants.

https://seekingalpha.com/news/3560466-madrigal-pharma-up-13-on-positive-data-on-nash-drug-resmetirom

Health insurers/hospitals rally on light at end of COVID-19 tunnel

Health insurers and managed care providers are adding to the broad market rally as European leaders mull steps to open their economies back up, starting with the cessation of quarantines, as the rate of new COVID-19 cases wanes across the continent.

Spain just reported the fewest new cases since March 20 and infections in Germany have dropped for the fifth straight day.

Denmark is set to reopen day care centers and primary schools.

At yesterday’s briefing from the Coronavirus Task Force in Washington, DC, President Trump said the government is close to completing guidelines to re-open the U.S. “hopefully ahead of schedule.” May 1 appears to be the target date.

Removal of quarantines should release pent-up demand for clinic visits, new prescriptions and elective surgical procedures.

Selected tickers: CVS Health (CVS +2.3%), eHealth (EHTH +6.0%), WellCare Health Plans (WCG), UnitedHealth Group (UNH +2.9%), Molina Healthcare (MOH +3.7%), Humana (HUM +3.2%), Cigna (CI +2.8%), Centene (CNC +2.3%), Anthem (ANTM +3.8%).

Hospital operators enjoying increased buying: Universal Health Services (UHS +2.9%), SunLink Health Systems (SSY +5.3%), Tenet Healthcare (THC +2.8%), Community Health Systems (CYH +13.4%), HCA Healthcare (HCA +4.6%).

https://seekingalpha.com/news/3560544-health-insurers-hospitals-rally-on-light-end-of-covidminus-19-tunnel

Sonnet BioTherapeutics up 87% on potential of technology for COVID-19

Nano cap Sonnet BioTherapeutics Holdings (SONN +87%) rockets northward on a healthy 26x surge in volume in apparent response to a report from New York think tank Altru Institute which has organized the Altru Global Virus Project aimed at identifying breakthroughs to treat COVID-19.

Altru’s first summary report focuses on Sonnet and its proprietary platform that may be “highly applicable” to the treatment of viral infections.

The company says its technology, called Fully Human Albumin Binding, enables modular plug-and-play drug development. Specifically, it utilizes a scaffold, based on its proprietary albumin-binding single-chain antibody fragment, to deliver recombinant human cytokines and other targets. Once administered into the body, the albumin-binding fragment attaches to albumin in the bloodstream and accumulates in inflamed tissue including, potentially, inflamed lung tissue in COVID-19 patients with respiratory problems.

Albumin, made by the liver, comprises ~60% of the total protein in the blood.

https://seekingalpha.com/news/3560588-sonnet-biotherapeutics-up-87-on-potential-of-technology-for-covidminus-19

Teladoc services surged in Q1 due to COVID-19

Reflecting strong demand for telehealth services due to COVID-19 quarantines, Teladoc (NYSE:TDOC) expects Q1 revenue of $180M – 181M, up 40% (midpoint) from a year ago and 4% above consensus of $173.5M.

Non-GAAP EBITDA should be $10M – 11M (+775%).

Total visit volume should be greater than 1.8M (+70%). Daily visits in the U.S. now exceed 20K.

Final results will be released on April 29.

Management will host a conference call today at 5:00 pm ET to discuss preliminary results.

Shares up 4% after hours.

https://seekingalpha.com/news/3560673-teladoc-services-surged-in-q1-due-to-covidminus-19