Hancock Jaffe (HJLI) Soars - What You Need to Know; Amgen (AMGN), Aurora Cannabis (ACB), MannKind (MNKD) In Focus; Advanced Micro Devices (AMD), GoPro (GPRO) Upcoming Key Date
Shares of Hancock Jaffe Laboratories Inc. (Nasdaq:HJLI) soared to touch the $2.00 mark in intraday trading Wednesday, finally closing at $1.74, up $0.29 (or +20.00%).
HJLI specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases.
HJLI is scheduled to begin a study for its CoreoGraft, bioprosthetic graft on January 29 at the Texas Heart Institute. The 30 day study will involve a series of CoreoGraft implantations tested for short term patency and flow rates, a problem which impacts a significant percentage of the 180,000 patients that have coronary bypass surgery each year in the U.S. The Company expects to have results from the CoreoGraft study available by the end of March 2019.
HJLI is also preparing for its VenoValve first-in-human trial in Bogota, Columbia, which will also begin in Q1 of 2019. The Company has begun to screen patients for the trial, and will announce the date for the first VenoValve implantations once initial patient enrollment is completed. The VenoValve was developed to treat severe cases of chronic venous insufficiency (CVI), a debilitating condition often associated with open venous ulcers and intense pain, and which afflicts approximately 4.5 million people in the U.S. and tens of millions of additional patients worldwide. There are currently no FDA approved treatments for deep venous CVI.
What You Need to Know About HJLI
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Amgen, Inc. (Nasdaq:AMGN) and Belgium-based biopharmaceutical giant UCB reported strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) - eighteen of 19 members voted yes - for the approval of EVENITY (romosozumab) - an investigational bone-forming monoclonal antibody - for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal late-stage studies.
While the FDA is not bound by the Advisory Committee's recommendations, it takes the advice into consideration when making its decision.
Osteoporosis is a disease of the bone that makes a person’s bones weak and more likely to break. There is a direct relationship between low estrogen levels after menopause and the development of osteoporosis. After menopause, bone resorption (breakdown) overtakes the building of new bone. In the U.S., one in two women over the age of 50 will experience an osteoporotic fracture, according to the National Osteoporosis Foundation.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
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Aurora Cannabis Inc. (NYSE:ACB) (TSX:ACB) said Wednesday that it proposes to offer pursuant to a private placement $250M aggregate principal amount of convertible senior notes due 2024, adding that it also intends to grant to the initial purchasers of the notes an option to purchase up to an additional $37.5M aggregate principal amount of notes.
Aurora expects to use the net proceeds from the offering of the notes to support its Canadian and international expansion initiatives, for future acquisitions and for general corporate purposes, including working capital requirements to continue the Company's accelerated growth.
Aurora, one of the world's largest and leading cannabis companies, is vertically integrated and horizontally diversified across every key segment of the value chain, from facility engineering and design to cannabis breeding and genetics research, cannabis and hemp production, derivatives, high value-add product development, home cultivation, wholesale and retail distribution.
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MannKind Corp. (Nasdaq:MNKD) shares surged more than 4% in the extended session Wednesday after the company reported the launch of a direct purchase program to help those with diabetes obtain its inhaled insulin, Afrezza, for as little as $4 a day.
MannKind has partnered with Eagle Pharmacy to process patients’ prescriptions and to ship Afrezza directly to their home. Payment is made using any major credit card.
Available by prescription, Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
MannKind focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension.
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Advanced Micro Devices, Inc. (Nasdaq:AMD) expects to report its fourth quarter and full-year 2018 financial results on Tuesday, January 29 after the close of market.
Advanced Micro Devices operates as a semiconductor company worldwide. It operates in two segments, Computing and Graphics; and Enterprise, Embedded and Semi-Custom.
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GoPro, Inc. (Nasdaq:GPRO) said that it will release its financial results for the fourth quarter and full-year 2018 after the cloing bell on Wednesday, February 6.
GoPro develops and sells cameras, and mountable and wearable accessories in the United States and internationally.
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