Ophthotech (OPHT) Inks License Deal for AAV-BEST1 Gene Therapy; Hancock Jaffe Labs (HJLI) In Focus; X4 Pharma (XFOR) Stock Offering; Ballard Power (BLDP) Upcoming Key Date
Shares of Ophthotech Corporation (Nasdaq:OPHT) climbed more than 15% in the extended session Thursday after the biopharmaceutical company said that it has converted its option and entered into an exclusive global license agreement with the University of Pennsylvania and the University of Florida Research Foundation for rights to develop and commercialize novel adeno-associated virus (AAV) gene therapy product candidates for the treatment of Best vitelliform macular dystrophy, also known as Best disease and other bestrophinopathies, which are diseases related to mutations to the BEST1 gene.
Patients with Best disease develop an egg yolk-like vitelliform lesion in their macular region, which over time leads to macular atrophy and permanent loss of central vision. There is currently no FDA or EMA approved therapy to treat this orphan inherited degenerative retinal disease. Ophthotech estimates that approximately 10,000 individuals in the United States and the five major European markets on a combined basis have Best disease.
Ophthotech develops novel therapies to treat ophthalmic diseases, with a focus on age-related and orphan retinal diseases.
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Hancock Jaffe Laboratories Inc. (Nasdaq:HJLI) shares surged $0.135 (or +6.59%) to $2.185 on Thursday's trading session after the company said that it has successfully implanted VenoValves in four additional patients for its first-in-human study in Bogota, Colombia.
HJLI has had several Pre-FDA meetings to discuss the pre-clinical and clinical pathway for FDA approval for the VenoValve, which was developed to treat 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.
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. HJLI expects to release preliminary data on the first group of VenoValve recipients at the end of June this year.
HJLI specializes in developing and manufacturing bioprosthetic (tissue based) medical devices to establish improved standards of care for treating cardiac and vascular diseases.
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X4 Pharmaceuticals, Inc. (Nasdaq:XFOR) said after the closing bell Thursday that it has commenced an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and Class A warrants to purchase its common stock.
Shares of the clinical-stage biopharmaceutical company plunged more than 23% in after-hours trading following the announcement.
X4 Pharmaceuticals is developing novel therapeutics designed to improve immune cell trafficking to treat rare diseases, including primary immunodeficiencies and cancer.
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Ballard Power Systems (Nasdaq:BLDP) (TSX:BLDP) will review its first quarter 2019 operating results on Thursday, May 2 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time)
Ballard Power provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical challenges or address new business opportunities
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