Pre-Open Stock Movers 01/07: (DVAX) (QURE) (ZUMZ) Higher; (TLOG) (CLBS) (EPZM) Lower (more...)
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TetraLogic Pharmaceuticals (Nasdaq: TLOG) 70% LOWER; announced the results of the interim analyses of two clinical studies. In a placebo controlled Phase 2 study of birinapant co-administered with azacitidine in first line higher risk patients suffering from myelodysplastic syndromes (MDS), birinapant did not demonstrate any clinical benefit over placebo on the primary endpoint of response rate after four months of therapy and met the bounds for futility. This interim analysis included the first 62 patients randomized in the trial. This study will now be terminated.
Dynavax Technologies Corporation (NASDAQ: DVAX) 27.5% HIGHER; reported preliminary top-line results from HBV-23, a Phase 3 trial of the safety and immunogenicity of its investigational hepatitis B vaccine, HEPLISAV-B, compared with a currently marketed vaccine, Engerix-B® , in adults 18 to 70 years of age. HEPLISAV-B participants received two doses, at zero and one month, and Engerix-B participants received three doses, at zero, one and six months. Both co-primary endpoints were met. The rates of clinically significant adverse events were consistent with randomization and similar to rates in prior trials and HEPLISAV-B provided a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants and in all participants as a group.
Caladrius Biosciences, Inc. (NASDAQ: CLBS) 24.5% LOWER; announces an increased focus of its strategic priorities and provides 2016 revenue guidance based on growth at its PCT subsidiary. Following a comprehensive review of the Companys existing operations and development pipeline, as well as an updated assessment of current market dynamics, current and expected future competitive therapies and the Companys financial resources, Caladrius has decided to shift greater focus and resources to its growing cell therapy process development, optimization and manufacturing services business at its PCT subsidiary. The rapidly developing cell therapy industry, with several cell-based therapies approaching market approvals which are expected to generate additional demand for commercial manufacturing infrastructure, along with PCTs continued trend of strong revenue growth, supports the Companys commitment to focus on growth opportunities for PCT. The Company has also reconfirmed its commitment to pursue further development of its immune modulation platform, with a Phase 2 proof-of-concept clinical trial for a T regulatory cell therapy in type 1 diabetes as the primary focus, while choosing to discontinue the current Phase 3 study of CLBS20 as monotherapy for metastatic melanoma.
Epizyme, Inc. (NASDAQ: EPZM) 19.9% LOWER; announced the pricing of its public offering of 13,333,334 shares of its common stock at a price of $9.00 per share before underwriting discounts.
Galena Biopharma, Inc. (Nasdaq: GALE) 18.2% LOWER; announced it intends to offer shares of its common stock and warrants to purchase its common stock in an underwritten public offering. The shares of common stock and warrants to purchase common stock are being offered as units. The shares of common stock and warrants will be immediately separable and issued separately. Raymond James & Associates, Inc. will act as sole book-running manager for the offering.
uniQure N.V. (Nasdaq: QURE) 14.1% HIGHER; announced preliminary topline results from the low-dose cohort of an ongoing Phase I/II clinical trial being conducted in adult hemophilia B patients treated with uniQure's novel AAV5/FIX gene therapy, AMT-060. All five patients in the low-dose cohort had Factor IX (FIX) phenotypic features of severe or moderately-severe hemophilia including documented Factor IX (FIX) levels less than 1-2% and required chronic treatment with prophylactic recombinant FIX (rFIX) therapy at the time of enrollment.
Finish Line (NASDAQ: FINL) 13.8% LOWER; reported Q3 EPS of ($0.07), versus the analyst estimate of ($0.03). Revenue for the quarter came in at $382.1 million versus the consensus estimate of $408.86 million. Finish Line comparable store sales decreased 5.8%
Akebia Therapeutics, Inc. (NASDAQ: AKBA) 10.4% LOWER; announced the pricing of an underwritten public offering of 7,250,000 shares of common stock at a price to the public of $9.00 per share.
Cempra, Inc. (Nasdaq: CEMP) 8.3% LOWER; announced that it has priced an underwritten public offering of 4,166,667 shares of its common stock at a price of $24.00 per share for aggregate gross proceeds of approximately $100 million.
Zumiez Inc. (NASDAQ: ZUMZ) 8% HIGHER; announced that total net sales for the five-week period ended January 2, 2016 decreased 6.2% to $134.5 million, compared to $143.4 million for the five-week period ended January 3, 2015. The Company's comparable sales decreased 8.9% for the five-week period ended January 2, 2016 compared to a comparable sales increase of 8.0% for the five-week period ended January 3, 2015. Based primarily on better than expected sales, the Company is raising its guidance and now expects fiscal 2015 fourth quarter net sales in the range of $237 to $239 million and net income per diluted share of approximately $0.45 to $0.47.
Sage Therapeutics, Inc. (Nasdaq: SAGE) 7.8% LOWER; announced the pricing of an underwritten public offering of 3,157,894 shares of its common stock at a public offering price of $47.50 per share, before underwriting discounts.
Otonomy, Inc. (NASDAQ: OTIC) 7% LOWER; announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $20.00 per share, for total gross proceeds of approximately $100 million before deducting underwriting discounts and commissions and other offering expenses.
Ardelyx, Inc. (NASDAQ: ARDX) 6.5% LOWER; commenced an underwritten public offering of up to $75,000,000 of shares of its common stock. All of the shares to be sold in the offering will be offered by Ardelyx.
Mistras Group, Inc. (NYSE: MG) 6.2% HIGHER; reported Q2 EPS of $0.39, $0.13 better than the analyst estimate of $0.26. Revenue for the quarter came in at $194.8 million versus the consensus estimate of $184.98 million. GUIDANCE: Mistras Group, Inc. sees FY2016 revenue of $710-725 million, versus the consensus of $716.65 million. Adjusted EBITDA range raised; now $79 million to $83 million. Profits for the first two quarters have exceeded plan, and the Company now expects Adjusted EBITDA will exceed the original guidance range, despite the difficult market.
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) 5.9% LOWER; announced the pricing of its underwritten public offering of 2,500,000 shares of its common stock at a price to the public of $23.00 per share
Globus Medical, Inc. (NYSE: GMED) 5.8% LOWER; announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2015, in advance of its annual national sales meeting being held later this week. The company anticipates fourth quarter 2015 sales of approximately $142.6 million, growing 10.7% as-reported or 11.5% in constant currency vs. fourth quarter 2014. Full year 2015 estimated sales are expected to be approximately $544.7 million, growing 14.8% as-reported or 16.0% in constant currency vs. the prior year, exceeding the companys previous guidance of $539 million. *** The Street sees Q4 EPS of $0.29 and revenue of $139 million.
Macy's, Inc. (NYSE: M) 4.7% HIGHER; cuts its outlook and announces additional store closings, streamlining of operations. In addition, announces Eastdil Secured, a leading real estate-focused investment bank, has been engaged by Macy’s, Inc. to approach potential interested parties, with assistance from Credit Suisse and Goldman Sachs, regarding forming partnerships or joint venture(s) for the company’s mall-based properties, as well as Macy’s flagship real estate assets in Manhattan, San Francisco, Chicago and Minneapolis.
MYR Group Inc. (NASDAQ: MYRG) 4.4% HIGHER; Engine Capital, L.P., one of the largest shareholders of MYR Group Inc. (NASDAQ: MYRG), with ownership of approximately 4.6% of MYRG's outstanding shares, today announced it has delivered a formal nomination of three highly qualified director candidates, Arnaud Ajdler, Grant G. McCullagh and John P. Schauerman, for election to the board of directors of MYRG (the "Board") at the Company's upcoming 2016 annual meeting of shareholders.
Alibaba (NYSE: BABA) 4.6% LOWER; sell-off in China; new Buy rating at Baird
Yahoo! Inc. (NASDAQ: YHOO) 3.6% LOWER; to cut up to 10% of its workforce
Greenbrier Cos. (NYSE: GBX) 3.3% HIGHER; reported Q1 EPS of $2.15, $0.52 better than the analyst estimate of $1.63. Revenue for the quarter came in at $802.4 million versus the consensus estimate of $758.81 million. New railcar backlog as of November 30, 2015 was 36,000 units with an estimated value of $4.14 billion (average unit sale price of $115,000), compared to 41,300 units with an estimated value of $4.71 billion (average unit sale price of $114,000) as of August 31, 2015. GUIDANCE: Greenbrier Cos. sees FY2016 EPS of $5.65-$6.15, versus the consensus of $5.98. Greenbrier Cos. sees FY2016 revenue of $2.0 billion, versus the consensus of $2.72 billion.
Zix Corporation (Nasdaq: ZIXI) 2.6% HIGHER; announced that its board of directors approved a share repurchase program that enables the company to purchase up to $15 million of its shares of common stock from time to time in the open market.
Alaska Air (NYSE: ALK) 1.9% LOWER; Credit Suisse downgraded from Outperform to Neutral
Resources Connection (NASDAQ: RECN) 1.4% LOWER; reported Q2 EPS of $0.23, $0.02 worse than the analyst estimate of $0.25. Revenue for the quarter came in at $150.9 million versus the consensus estimate of $154.93 million.
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