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March 31, 2014
10:47 EDTHARTHarvard Apparatus says response from FDA meeting 'very favorable'
Harvard Apparatus said in investor presentation slides that its pre-Investigational New Drug meeting with the FDA at the end of January yielded a "very favorable response." The company expects an orphan designation determination by the FDA in Q2. Harvard added that it has approximately two years of capital at current burn rates and no debt. Harvard said that eight patients are using its bioreactor technology with six of those alive at February 2014. The two that did not survive died of unrelated causes, it said. Shares of Harvard Apparatus are up 6%, or 42c, to $7.71 in morning trading.
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November 26, 2014
07:33 EDTHARTHarvard Apparatus says no longer supporting studies in Russia
Harvard Apparatus Regenerative Technology announced that it will no longer be providing its HART-Trachea product for future transplant procedures performed at Krasnodar, Russia as part of the ongoing airway transplant studies there. HART will continue to focus primarily on completing preclinical work necessary to initiate clinical trials for its HART-Trachea product in the EU and U.S. It has made recent progress in the U.S. and EU, including the granting of orphan designation by the FDA and a productive meeting with the Medicines and Healthcare Products Regulatory Agency of the U.K. HART anticipates that during 2015 it will file its Investigational New Drug application to initiate a U.S. clinical trial and a Clinical Trial Authorization application to initiate an EU clinical trial.

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