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16:21 EST Moderna to provide 13M doses of COVID vaccine to Philippines - Moderna has announced a supply agreement with the Government of The Philippines for 13M doses of the COVID-19 Vaccine Moderna. Under the terms of this agreement, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the company will work with regulators to pursue necessary approvals prior to distribution. A separate agreement with the Philippine Government and private sector for the supply of an additional 7M doses is also anticipated.

16:13 EST Atea Pharmaceuticals presents Phase 1 results for AT-527 - Atea Pharmaceuticals presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid polymerase, a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging. In the Phase 1 study, 20 healthy volunteers were randomized 1:1 to receive oral AT-527 550 mg twice daily or matching placebo for 5 days. The purpose of this study was to assess the safety and pharmacokinetics of AT-527 in healthy volunteers and to predict human lung exposure of intracellular AT-9010, the active triphosphate metabolite of AT-527. Safety assessments included adverse events, vital signs, electrocardiograms, and standard safety laboratory tests. Intensive PK sampling, performed after the first and last two doses, provided information on plasma exposures of AT-511, the free base of AT-527, a hemisulfate salt, and its metabolites including AT-273, the guanosine nucleoside metabolite, a measurable surrogate for intracellular AT-9010. The study results showed AT-527 was well tolerated with a favorable safety profile. There were no discontinuations, serious AEs, clinically significant changes in vital signs, or ECGs observed. The data also demonstrated that AT-511 was rapidly absorbed, followed by fast and extensive stepwise metabolic activation ultimately to the intracellular TP metabolite AT-9010, reflected by plasma AT-273. AT-527 550 mg BID led to fast attainment of steady-state levels of AT-273 within two days of dosing. Plasma levels of AT-273 were further used to predict lung concentrations of AT-9010 using a scaling factor of 1.2X which was previously determined from in vivo tissue distribution of the triphosphate metabolite in cynomolgus monkeys. Beginning as early as three hours after the first dose, and maintained thereafter throughout the five days of dosing, predicted lung AT-9010 levels were consistently above the EC90 level of 0.5 microM for in vitro inhibition by the drug of SARS-CoV-2 replication. These results indicate the potential of AT-527 for the treatment of COVID-19 and are supportive of the dosing regimen of 550 mg BID.