Unusual 11 Mid-Day Movers 9/6: (CLCD) (CPHD) (NAV) Higher; (TNXP) (KPTI) (PTI) Lower
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) 54.8% LOWER; announced preliminary topline results from its Phase 3 clinical study, AFFIRM, designed to evaluate the safety and efficacy of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), 2.8 mg, in patients with fibromyalgia. AFFIRM was a 12-week randomized, double-blind, placebo-controlled trial of TNX-102 SL taken daily at bedtime, in which 519 participants were enrolled at 35 centers in the U.S. Fibromyalgia is a multi-symptom disorder that originates in the central nervous system and is characterized by widespread pain, non-restorative sleep, fatigue, and disability.
Cepheid (Nasdaq: CPHD) 51.9% HIGHER; announced that it has entered into a definitive agreement with Danaher Corporation (NYSE: DHR) under which Danaher will acquire all of the outstanding shares of Cepheid common stock for $53 per share in cash, or a total enterprise value of approximately $4 billion including indebtedness and net of acquired cash.
Navistar International Corporation (NYSE: NAV) 41.5% HIGHER; announced that it has formed a wide-ranging strategic alliance with Volkswagen Truck & Bus, which includes an equity investment in Navistar by Volkswagen Truck & Bus and framework agreements for strategic technology and supply collaboration and a procurement joint venture.
Dynavax Technologies Corporation (Nasdaq: DVAX) 25.9% HIGHER; announced that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016.
Burcon NutraScience Corporation (Nasdaq: BUR) 19.7% HIGHER; announced that, Archer Daniels Midland Company (NYSE: ADM), Burcon’s license and production partner for CLARISOY soy protein, has confirmed plans to achieve full commercial production of CLARISOY this year. ADM plans to begin commissioning the first large-scale CLARISOY production facility at its North American headquarters in Decatur, Illinois, during the fourth quarter of 2016.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) 15.6% LOWER; reported positive top-line results from its Phase 2b STORM study evaluating the activity of selinexor (KPT-330) in multiple myeloma (MM). Selinexor, the Company’s lead, novel, oral Selective Inhibitor of Nuclear Export / SINE™ compound, is being developed for the treatment of a variety of malignancies, including MM. Karyopharm also provided an overview of the planned development path for selinexor in MM.
Spectra Energy Corp (NYSE: SE) 14.0% HIGHER; Enbridge and Spectra Energy announced that they have entered into a definitive merger agreement under which Enbridge and Spectra Energy will combine in a stock-for-stock merger transaction (the "Transaction"), which values Spectra Energy common stock at approximately C$37 billion (US$28 billion), based on the closing price of Enbridge's common shares on September 2, 2016. The combination will create the largest energy infrastructure company in North America and one of the largest globally based on a pro-forma enterprise value of approximately C$165 billion (US$127 billion). The Transaction was unanimously approved by the Boards of Directors of both companies and is expected to close in the first quarter of 2017, subject to shareholder and certain regulatory approvals, and other customary conditions.
Proteostasis Therapeutics, Inc. (Nasdaq: PTI) 7.0% LOWER; filed an amended S-1 with the U.S. SEC earlier Tuesday.
CEL-SCI Corporation (NYSE: CVM) 7.0% LOWER; announced that its founder, President and Chairman of the Board, Maximilian de Clara has resigned for personal health reasons, effective immediately. The 87 year-old visionary funded the original research of what has become CEL-SCI’s investigational drug Multikine* at the Max Planck Institute in Germany. From this he started the Company and now the Multikine Phase 3 study is being run in 24 countries with multiple respected partners. We thank him for his dedication and service to the Company, and wish him the best of health.
Minerals Technologies Inc. (NYSE: MTX) 6.0% LOWER; announced that Joseph C. Muscari, Chairman and Chief Executive Officer, died unexpectedly on September 3, 2016. He was 69.
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