FDA OKs Akorn's (AKRX) ANDAs; Hancock Jaffe Labs (HJLI) Surges; BfArM Grants Cannabis Cultivation License to Aphria (APHA); Bombardier (BDRBF), iQIYI (IQ) Upcoming Key Date
Shares of Akorn, Inc. (Nasdaq:AKRX) climbed more than 10% in the extended session Thursday after the company said that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) - indicated for the temporary relief of hay fever and other upper respiratory allergies in adult and pediatric patients 4 years of age and older -.
The specialty generic pharmaceutical company also received a new ANDA approval from the FDA for Loteprednol Etabonate Ophthalmic Suspension, 0.5% - indicated for the treatment of post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation -.
Akorn develops, manufactures, and markets generic and branded prescription pharmaceuticals, over-the-counter (OTC) consumer health products, and animal health pharmaceuticals.
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Hancock Jaffe Laboratories Inc. (Nasdaq:HJLI) shares surged $0.12 (or +5.31%) to $2.38 on Thursday's trading session.
HJLI specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases. The company currently has two lead products: the VenoValve and the CoreoGraft.
HJLI's VenoValve was developed to treat severe cases of chronic venous insufficiency (CVI), a debilitating condition often associated with open venous ulcers and intense pain. Approximately 2.4 million patients in the U.S. suffer from CVI due to reflux in the deep venous system, and there are currently no FDA approved treatments for the condition.
HJLI has had several Pre-FDA meetings to discuss the pre-clinical and clinical pathway for FDA approval for the VenoValve. Preclinical prototype testing, including in vivo animal studies, and in vitro hemodynamic studies, have demonstrated that the VenoValve mimics the function of a properly functioning native venous valve.
Based upon feedback from the FDA, HJLI agreed to conduct a small first-in-human study in Colombia prior to the U.S. pivotal trial.
The company recently successfully implanted VenoValves in four additional patients for its first-in-human study in Bogota, Colombia and expects to release preliminary data on the first group of VenoValve recipients at the end of June this year.
HJLI's CoreoGraft is a potential replacement for saphenous vein grafts (SVGs) commonly used to revascularize the heart during coronary artery bypass graft (CABG) surgeries.
With approximately 200,000 CABG surgeries performed each year in the U.S., CABG surgery is the most commonly performed cardiac surgical procedure accounting for over 62% of all cardiac surgeries. In addition to the SVG harvest procedure being painful and prone to complications for the patient, SVGs are known to have significant short-term and long-term failure rates, restricting needed blood flow to the heart and resulting in symptoms such as chest pain, shortness of breath, and increased cardiac mortality rates.
HJLI is currently conducting a pre-clinical feasibility study for the CoreoGraft at the world renowned Texas Heart Institute. The company expects results from the study to be released in June of this year.
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Aphria Inc. (NYSE:APHA) (TSX:APHA) said after the closing bell Thursday that its German subsidiary Aphria Deutschland GmbH has secured a license for the domestic cultivation of medical cannabis from the German Federal Institute for Drugs and Medical Devices (BfArM), following the conclusion of a mandatory 10-day standstill period for public contracts.
Aphria was granted a cultivation license for four of the nine total lots awarded by BfArM and is awaiting the completion of the tender process for the four remaining lots under review, one of which was provisionally awarded to its German subsidiary.
Aphria produces and sells medical cannabis in Canada and internationally.
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Bombardier (OTCMKTS:BDRBF) (TSX:BBD.B) (TSX:BBD.A) expects to release its financial results for the first quarter ended March 31, 2019 before the opening bell on Thursday, May 2.
Bombardier is a global leader in the transportation industry, creating innovative and game-changing planes and trains.
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iQIYI, Inc. (Nasdaq:IQ) will report its first quarter 2019 financial results after the market closes on Thursday, May 16.
iQIYI is an innovative market-leading online entertainment service in China.
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