Today’s Daily Dose brings you news about Cassava Sciences’ research grant from the National Institutes of Health for developing Alzheimer’s disease drug; Edwards Lifesciences’ Q1 financial results; Enzo Biochem’s launch of the next-generation COVID-19 test kits and Johnson & Johnson’s deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.
Cassava Sciences Inc. (SAVA) has been awarded a new $2.5 million research grant award from the National Institutes of Health to support the on-going clinical evaluation of PTI-125, the Company’s lead investigational drug in an open-label study in Alzheimer’s disease.
The open-label, multi-center, extension study was initiated in March of this year and is designed to monitor the long-term safety and tolerability of PTI-125 at 100 mg twice daily for 12 months. The study’s target enrollment is approximately 100 patients with mild-to-moderate Alzheimer’s disease, including patients from prior studies of PTI-125.
A phase IIb study of PTI-125 in patients with Alzheimer’s disease is underway, with top-line results expected approximately mid-year 2020.
SAVA closed Thursday’s trading at $7.31, up 31.95%.
Edwards Lifesciences Corp.’s (EW) net income for the first quarter ended March 31, 2020, is $310.6 million or $1.47 per share on net sales of $1.1 billion. This compares with net income of $249.7 million or $1.18 per share and net sales of $993 million in the year-ago quarter.
The Company noted that Q2 sales will be most hit by the impact of COVID-19, while the third quarter will show a gradual recovery, with the fourth quarter resembling its original expectations for sales.
For the second quarter of 2020, the Company projects total sales to be between $700 and $900 million.
Full-year 2020 sales are now expected to be $4.0 to $4.5 billion versus the Company’s previous range of $4.6 to $5.0 billion. The annual adjusted earnings per share for the year are expected to range between $4.75 and $5.25, down from the previous guidance of $6.15 to $6.40.
EW closed Thursday’s trading at $221.04, up 2.09%.
Enzo Biochem Inc. (ENZ) has launched the next-generation COVID-19 test kits under the FDA’s Emergency Use Authorization authority. The test uses the Company’s proprietary GENFLEX open diagnostic platform, which includes a collection system, sample processing, and molecular analytic products.
The Company is also developing IgG/IgM Antibody Test for detecting and quantifying antibodies to identify the individuals who were infected with, or without, symptoms, which aids in immunity detection.
Also in the Company’s COVID-19 Program are Cytokine Storm Immunoassay (for Inflammation Monitoring) and drug candidate SK1-I for the prevention and/or treatment of Cytokine Release Syndrome and respiratory failure in COVID-19 patients.
ENZ closed Thursday’s trading at $2.65, up 22.12%.
Johnson & Johnson’s (JNJ) subsidiary Janssen Pharmaceutical Companies has entered into a deal with Emergent BioSolutions Inc. (EBS) to expand manufacturing capabilities for its COVID-19 Vaccine candidate.
This is the first in a series of prospective global collaboration agreements designed to accelerate manufacturing of Johnson & Johnson’s COVID-19 vaccine candidate, and further the Company’s goal to supply more than one billion doses of the vaccine globally.
Under the terms of the manufacturing agreement, Johnson & Johnson is investing to expand drug substance capacity related to the vaccine candidate. Emergent will provide drug substance manufacturing services with its molecule-to-market contract development and manufacturing organization (CDMO) offering, beginning this year.
Johnson & Johnson is planning to initiate phase I human clinical studies of its vaccine candidate in September 2020.
JNJ touched an all-time high of $157 in intraday trading on Thursday, before closing at $155.51, up 1.65%.
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