Pre-Open Stock Movers 09/28: (SEED) (AVXL) (ATHX) Higher; (GALT) (TPX) (SONC) Lower (more...)

September 28, 2016 9:10 AM EDT

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Today's Pre-Open Stock Movers

Galectin Therapeutics Inc. (NASDAQ: GALT) 48% LOWER; announced topline results from NASH-FX, its Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of GR-MD-02 in 30 nonalcoholic steatohepatitis (NASH) patients with advanced fibrosis. This exploratory, single site, short-treatment (four months of therapy), randomized study did not meet its primary biomarker endpoint as measured by LiverMultiScan (LMS, Perspectum Diagnostics), a magnetic resonance imaging test that evaluates inflammation and fibrosis. The trial also did not meet secondary endpoints that measure liver stiffness as a surrogate for fibrosis, with FibroScan® and magnetic resonance elastography (MRE). While all patients had a baseline liver biopsy to establish the diagnosis and fibrosis severity, liver biopsies were not performed at the end of the study following treatment due to safety considerations involved with liver biopsy-related risk in a short duration trial. GR-MD-02 was found to be safe and well tolerated among the patient population with no serious adverse events.

Origin Agritech Limited (NASDAQ: SEED) 47.2% HIGHER; announced the company has entered into a definitive agreement to sell its proprietary China-based commercial corn seed production and distribution business for RMB 400 million (approximately USD $60 million) to Beijing Shihui Agricultural Development Co, Ltd.

Tempur Sealy International, Inc. (NYSE: TPX) 22.2% LOWER; said third quarter net sales are below prior expectations. They currently expect net sales for the full year to be down 1 to 3 percent as compared to 2015. For the full year 2016, the Company currently expects Adjusted EBITDA to range from $500 million to $525 million."

Anavex Life Sciences Corp. (Nasdaq: AVXL) 22% HIGHER; signed a material transfer agreement with Biogen (NASDAQ: BIIB) under which Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73 in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model.

Athersys, Inc. (NASDAQ: ATHX) 16.3% HIGHER; announced today that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.

Galena Biopharma, Inc. (NASDAQ: GALE) 8.7% HIGHER; announced data from the Companys GALE-301 Phase 1/2a clinical trial was presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in New York, NY. The focus of the presentation was on the association between clinical outcomes and folate binding protein (FBP) expression. GALE-301 is administered with the adjuvant granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in disease-free ovarian and endometrial cancer patients.

Sonic Corp. (NASDAQ: SONC) 6.4% LOWER; announced preliminary results for its fourth fiscal quarter ended August 31, 2016. The company estimates that system-wide same-store sales for its fourth fiscal quarter decreased approximately 2.0%. Estimated same-store sales performance reflects a decrease of approximately 3.0% at company drive-ins and a decrease of approximately 1.8% at franchise drive-ins for the fourth fiscal quarter. Additionally, net income per diluted share is anticipated to be $0.51 to $0.53. Adjusted net income per diluted share is estimated to be $0.43 to $0.45 for the fourth fiscal quarter. (Street sees Q4 EPS of $0.48)

Tile Shop Holdings Inc. (NASD: TTS) 6.3% HIGHER; will replace Epiq Systems Inc. (NASD: EPIQ) in the S&P SmallCap 600.

Sarepta Therapeutic (NASDAQ: SRPT) 4.3% HIGHER; PTs raised at JMP Securities ($90) and RBC Capital ($108).

Nike (NYSE: NKE) 4.2% LOWER; reported Q1 EPS of $0.73, $0.17 better than the analyst estimate of $0.56. Revenue for the quarter came in at $9.06 billion versus the consensus estimate of $8.87 billion. Greater China revenue rose 21%, ex. FX, and North America revenue rose 6%. Futures orders rose 7%,, est. up 8%.

Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) 4% LOWER; announced that it intends to commence an underwritten public offering of its ordinary shares.

Harmonic (NASDAQ: HLIT) 4% HIGHER; entered into a warrant agreement with Comcast Corporation (NASDAQ: CMCSA). The agreement provides Comcast with the opportunity to acquire shares of common stock of Harmonic based on specific CableOS™ and other Harmonic product sales and deployment milestones during the term of the warrant.

Versartis, Inc. (Nasdaq: VSAR) 4% LOWER; announced that it has commenced an underwritten public offering of shares of its common stock. The company expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering

Array BioPharma (Nasdaq: ARRY) 3.5% LOWER; announced that it has commenced an underwritten public offering of $100 million of shares of its common stock. Array BioPharma also intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock offered in the public offering. All of the shares in the offering are to be sold by Array BioPharma.

Shopify (NYSE: SHOP) 3% LOWER; Morgan Stanley downgraded from Overweight to Equalweight with a price target of $47.00 (from $37.00).

Cintas Corp. (NASDAQ: CTAS) 3% HIGHER; reported Q1 EPS of $1.26, $0.18 better than the analyst estimate of $1.08. Revenue for the quarter came in at $1.29 billion versus the consensus estimate of $1.28 billion. GUIDANCE: Cintas Corp. sees FY2017 EPS of $4.55-$4.63, versus the consensus of $4.42. Cintas Corp. sees FY2017 revenue of $5.160-5.225 billion, versus the consensus of $5.19 billion.

Great Plains Energy Incorporated (NYSE: GXP) 2% LOWER; announced the commencement of concurrent underwritten public offerings of 52,600,000 shares of its common stock and 15,000,000 depositary shares, each representing a 1/20th ownership interest in a share of its Series B Mandatory Convertible Preferred Stock, without par value, with a liquidation preference of $1,000 per share of Mandatory Convertible Preferred Stock. In addition, Great Plains Energy will grant the underwriters in each respective offering a 30-day option to purchase up to 7,890,000 additional shares of common stock and up to 2,250,000 additional depositary shares.

Foot Locker (NYSE: FL) 2% LOWER; down with Nike

Dillard's Inc. (NYSE: DDS) 2% HIGHER; Credit Suisse upgraded from Neutral to Outperform with a price target of $70.00 (from $63.00)

Fiesta Restaurant Group, Inc. (Nasdaq: FRGI) 2% HIGHER; announced that its Board of Directors (the Board) has appointed Danny Meisenheimer interim CEO and President of the Company. Mr. Tim Taft is retiring as CEO and President, and resigning as a director effective September 30, 2016.

Baidu (NASDAQ: BIDU) 2% LOWER; Deutsche Bank downgraded from Buy to Hold with a price target of $201.00 (from $219.00).

Twitter, Inc. (NYSE: TWTR) 1.3% LOWER; Mizuho Securities downgraded from Neutral to Underperform with a price target of $15.00 citing valuation after the recent run-up on M&A speculation.

Macy's (NYSE: M) 1% LOWER; Credit Suisse downgraded from Outperform to Neutral with a price target of $40.00.

BlackBerry (NASDAQ: BBRY) 1% HIGHER; reported Q2 EPS of $0.00, $0.05 better than the analyst estimate of ($0.05). Revenue for the quarter came in at $352 million versus the consensus estimate of $393.75 million. The company lifted its FY17 adjusted EPS forecast to ($0.05) - $0.00. The Street is looking for ($0.15). Names new CFO.

Alphabet (NASDAQ: GOOGL) 1% LOWER; Wedbush downgraded from Neutral to Underperform.

Pier 1 Imports, Inc. (NYSE: PIR) 1% LOWER; announced today that its Board of Directors has adopted a Shareholder Rights Protection Agreement effective September 27, 2016, and declared a dividend of one right on each outstanding share of the Company's common stock, payable to holders of record as of the close of business on October 7, 2016.

A&T (NYSE: T) 1% LOWER; UBS downgraded from Buy to Neutral with a price target of $43.00 (from $46.00).

Coty (NYSE: COTY) 0.6% HIGHER; to Replace Diamond Offshore Drilling (NYSE: DO) in S&P 500



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