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Navidea Biopharmaceuticals, Inc. (NYSE: NAVB) 87% HIGHER; announced that it has executed a Letter of Intent with Cardinal Health, Inc. (NYSE: CAH) for the sale of all rights, title and interest to Navideas Lymphoseek product for all FDA-approved, pending and future oncology diagnostic indications in North America, subject to certain limitations, as well as certain other related assets. Under the terms of the LOI, Navidea would receive $80 million at closing, with future consideration tied to annual sales of the Lymphoseek product and certain sales-based milestones. Total consideration to Navidea would be capped at $310 million.
CoLucid Pharmaceuticals, Inc. (NASDAQ: CLCD) 84.7% HIGHER; announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) 54.1% 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. The AFFIRM data did not achieve statistical significance in the primary efficacy endpoint: the proportion of patients who reported a 30 percent or greater reduction in pain from baseline to the end of the 12-week treatment period based on the pre-specified primary analysis (p=0.095, Table 1).
Cepheid (NASDAQ: CPHD) 52% HIGHER; 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) 51% HIGHER; 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 (NASDAQ: DVAX) 21.4% HIGHER; recovers some of Friday's 32% loss after providing an update on VRBPAC cancellation.
Spectra Energy Corp (NYSE: SE) 9.3% HIGHER; Enbridge Inc. (NYSE: ENB) and Spectra Energy Corp (NYSE: SE) 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, 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.
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) 8.2% 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 Companys 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.
Resolute Energy (NYSE: REN) 5.8% HIGHER; continued momentum. Northland Capital Markets raised its price target to $35.00 (from $12.00).
Stratasys (Nasdaq: SSYS) 5.3% HIGHER; following news that GE will acquire two suppliers of additive manufacturing equipment, Arcam AB and SLM Solutions Group AG for $1.4 billion.
comScore (NASDAQ: SCOR) 5.2% LOWER; SunTrust Robinson Humphrey downgraded from Buy to Neutral with a price target of $34.00 (from $35.00).
3D Systems (NYSE: DDD) 3.9% HIGHER; following news that GE will acquire two suppliers of additive manufacturing equipment, Arcam AB and SLM Solutions Group AG for $1.4 billion.
Marvell Technology (NASDAQ: MRVL) 3.8% LOWER; reported Q2 EPS of $0.18, $0.07 better than the analyst estimate of $0.11. Revenue for the quarter came in at $626 million versus the consensus estimate of $629.96 million. GUIDANCE: Marvell Technology sees Q3 2017 EPS of $0.08-$0.13, versus the consensus of $0.14.
Hecla Mining (NYSE: HL) 3.4% HIGHER; Rodman & Renshaw initiated coverage with a Buy rating and a price target of $9.
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