Applied Genetic (AGTC), Biogen (BIIB) to End Collaboration Deal; VBI Vaccines (VBIV), Tocagen (TOCA) Stock Offering; Hancock Jaffe (HJLI) a Step Closer to VenoValve Trial
Shares of Applied Genetic Technologies Corp. (Nasdaq:AGTC) plunged more than 35% in the extended session Wednesday after the company reported interim findings from its early-stage study evaluating rAAV2tYF-CB-hRS1 for X-linked retinoschisis (XLRS) and said that it will regain full rights to the XLRS and X-linked retinitis pigmentosa (XLRP) programs and the three other partnered discovery programs following Biogen Inc.'s (Nasdaq:BIIB) termination of the collaboration agreement, which will be effective on March 8, 2019.
According to Applied Genetic, results from the study show that rAAV2tYF-CB-hRS1 is generally safe and well-tolerated, but no signs of clinical activity were observed at six-months. The company will complete patient monitoring activities on the XLRS program according to the clinical protocol but will not further develop the product.
Applied Genetic Technologies is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases.
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VBI Vaccines Inc. (Nasdaq:VBIV) shares tumbled over 10% in after-hours trading Wednesday as the company said that it has commenced an underwritten public offering of its common shares, adding that the offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
VBI Vaccines is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology.
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Colombia’s INVIMA (the Colombian equivalent of the U.S. FDA) recently completed its review of Hancock Jaffe Laboratories Inc.'s (Nasdaq:HJLI) application for a first-in-human trial of its VenoValve, a porcine tissue based valve, which is intended to be surgically implanted in the deep venous system of the leg to treat Chronic Venue Insufficiency
HJLI now will present its application for its first-in-human trial for the VenoValve to INVIMA’s Medical Device and Other Technologies Committee at its upcoming meeting this month.
Upon approval, patient enrollment will begin immediately. HJLI's VenoValves for the first-in-human trial have been manufactured and inspected, and are ready for shipment.
HJLI specializes in developing and manufacturing bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases.
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Tocagen Inc. (Nasdaq:TOCA) has priced an underwritten public offering of 3,000,000 shares of its common stock at a price to the public of $10.00 per share. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of Tocagen's common stock at the public offering price, less the underwriting discounts and commissions.
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer.
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