lady luck : NuPathe - zurück am richtigen Pfad gen Norden!
NuPathe (Nasdaq:PATH - News) is an emerging biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders. NuPathe?s lead product candidate, NP101 (also known as Zelrix), is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine, and is the first-ever submission to the U.S. Food and Drug Administration (FDA) of a transdermal patch for migraine treatment. The patch is designed to provide migraine patients fast onset and sustained relief of the cardinal migraine symptoms including headache pain and migraine-related nausea (MRN). On August 30, 2011, NuPathe announced receipt of a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for its migraine patch. "Following an end-of-review meeting with the FDA on November 9th to discuss the questions the FDA raised in its CRL, NuPathe expects to determine the timing of the resubmission of its NDA and the commercial launch of its migraine patch. In addition to NP101, NuPathe has two additional proprietary product candidates: NP201 for the continuous symptomatic treatment of Parkinson?s disease, for which the company plans to partner, and NP202, in preclinical development, for the long-term treatment of schizophrenia and bipolar disorder. NuPathe?s initial public offering of common stock in August 2010 raised $50 million in gross proceeds. Safeguard has deployed $18.3 million of capital in NuPathe since September 2006 and owns 18% of its outstanding common shares.