Pre-Open Stock Movers 05/20: (SRPT) (ISR) (PBY) Higher; (LPTN) (ETSY) (ACHN) Lower (more...)

May 20, 2015 9:32 AM EDT
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Lpath (NASDAQ: LPTN) 75.6% LOWER; announced that its multicenter, Phase 2 "Nexus" clinical trial evaluating iSONEP in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy.

Sarepta Therapeutics (NASDAQ: SRPT) 45.3% HIGHER; announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.

IsoRay (NYSE: ISR) 35.4% HIGHER; Cesium-131 Lung Cancer Treatment Reports 96% Success in Local Control and 100% Survival at 5 Years in High Risk Patients in Newly Published Report

AVEO Pharmaceuticals (NASDAQ: AVEO) 30.4% HIGHER; announced that final results from the TIVO-1 extension study, known as Study 902, in which patients with advanced renal cell carcinoma (RCC) received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Companys Phase 3 TIVO-1 first-line RCC study, will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The Company previously reported interim median progression free survival (PFS) results of 8.4 months among the 163 patients enrolled in Study 902. Final results now show a median PFS in this setting of 11.0 months and median overall survival (OS) of 21.6 months, demonstrating the efficacy of tivozanib in a VEGF treatment refractory population.

Genocea Biosciences (NASDAQ: GNCA) 21.5% HIGHER; announced positive top-line data from a Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. During the 28-day observation period immediately after completion of dosing, the best dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a highly statistically significant (p<0.0001) 55 percent reduction from baseline in the viral shedding rate, the primary endpoint of the trial and a measure of anti-viral activity. All dose combinations tested, including the successful 30 µg per protein / 50 µg of adjuvant dose from the prior Phase 1/2a trial, demonstrated a statistically significant viral shedding rate reduction versus baseline and only the lowest dose combination did not demonstrate a statistically significant reduction versus placebo.

Etsy (NASDAQ: ETSY) 17% LOWER; reported Q1 EPS of ($0.84), versus ($0.01) reported last year. Revenue for the quarter came in at $58.54 million, versus $40.54 million reported last year.

Dycom Industries (NYSE: DY) 14.8% HIGHER; reported Q3 EPS of $0.58, $0.21 better than the analyst estimate of $0.37. Revenue for the quarter came in at $492.4 million versus the consensus estimate of $468.2 million. Dycom Industries sees Q4 2015 EPS of $0.74-$0.82, versus the consensus of $0.58. Dycom Industries sees Q4 2015 revenue of $550-570 million, versus the consensus of $522.81 million.

Pep Boys (NYSE: PBY) 13% HIGHER; has been approached about a potential sale by private equity firms including Golden Gate Capital, the Wall Street Journal reported late Tuesday citing people familiar with the matter.

Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) 10.4% LOWER; Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that it has entered into an exclusive worldwide license and collaboration arrangement with Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422 and sovaprevir.

CNinsure (NASDAQ: CISG) 8.5% LOWER; reported Q1 EPS of $0.07, $0.03 worse than the analyst estimate of $0.10. Revenue for the quarter came in at $93.5 million versus the consensus estimate of $91.3 million.

PlasmaTech Biopharma (NASDAQ: PTBI) 7.8% HIGHER; announced that the U.S. Food and Drug Administration (FDA) had granted both Orphan Drug Designation and Rare Pediatric Disease Designation for both of PlasmaTech Biopharmaceuticals' lead product candidates for the treatment of Sanfilippo Syndromes A and B.

American Eagle Outfitters (NYSE: AEO) 6.9% HIGHER; reported Q1 EPS of $0.15, $0.03 better than the analyst estimate of $0.12. Revenue for the quarter came in at $700 million versus the consensus estimate of $691.77 million. Consolidated comparable sales increased 7%, compared to a 10% decrease last year. Based on a high single digit increase in comparable sales, American Eagle Outfitters sees Q2 2015 EPS of $0.11-$0.14, versus the consensus of $0.11.

EnteroMedics (NASDAQ: ETRM) 5.6% HIGHER; announced the first ever commercial implant of the Maestro Rechargeable System, delivering vBloc® Neurometabolic Therapy, in the United States. The procedure was performed on Wednesday, May 13, 2015 at Tufts Medical Center by surgeon Sajani Shah, MD. The surgery proceeded without incident and the patient returned home on the same day as the surgery, is recovering well and has returned to work full-time.

Lowe's Cos. (NYSE: LOW) 4.5% LOWER; reported Q1 EPS of $0.70, $0.04 worse than the analyst estimate of $0.74. Revenue for the quarter came in at $14.1 billion versus the consensus estimate of $14.27 billion. Comparable sales for the U.S. home improvement business increased 5.3 percent.

Computer Sciences (NYSE: CSC) 4.4% HIGHER; announced that its Board of Directors has unanimously approved a plan to separate the company into two publicly traded, pure-play leaders: one to serve commercial and government clients globally and one to serve public sector clients in the U.S.

Norwegian Cruise Line (NASDAQ: NCLH) 4% LOWER; announced the launch of a secondary public offering of 20 million of its ordinary shares by certain funds affiliated with Apollo Global Management, LLC, Star NCLC Holdings Ltd. and certain funds affiliated with TPG Global, LLC pursuant to an automatic shelf registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission. Norwegian will not sell any ordinary shares in the offering and will not receive any of the proceeds from the offering. The total number of Norwegian ordinary shares outstanding will not change as a result of the offering. Goldman, Sachs & Co. is acting as the sole underwriter for the offering.

El Pollo Loco Holdings, Inc. (NASDAQ: LOCO) 4% LOWER; minimum wage hike in LA

Apollo Global Management (NYSE: APO) 3.9% HIGHER; Morgan Stanley upgraded from Underweight to Equalweight with a price target of $23

Cimarex Energy (NYSE: XEC) 3.7% LOWER; announced that it intends to commence a registered public offering of 6,000,000 shares of its common stock, subject to market conditions. Cimarex also expects to grant the underwriters an option to purchase up to 900,000 additional shares of its common stock. Net proceeds from the offering are expected to be used for general corporate purposes and to fund increased drilling and completion activity in the second half of 2015 and more significantly in 2016. J.P. Morgan and Barclays are acting as joint book-running managers for the offering.

Yahoo! (NASDAQ: YHOO) 3.4% HIGHER; issued the following statement early Wednesday: An IRS representative stated Tuesday that the IRS plans to study its rules for issuing private letter rulings regarding the active trade or business requirement in spin-off transactions and will hold off processing new ruling requests. Yahoo understands that the IRS’s statement is not specific to Yahoo’s planned Q4 2015 spin-off of its remaining stake in Alibaba Group (NYSE: BABA) and Yahoo Small Business, reflects no change in applicable law, and does not affect previously filed ruling requests. Yahoo filed its pending ruling request with the IRS in Q1 2015. Yahoo continues to work toward completing the planned spin-off in Q4 2015.

Time Warner Cable (NYSE: TWC) 3% HIGHER; Reports Altice SA might be eyeing the company for a takeover.

Lending Club (NYSE: LC) 2.8% HIGHER; Morgan Stanley upgraded from Equalweight to Overweight

Target (NYSE: TGT) 2.3% HIGHER; reported Q1 EPS of $1.10, $0.07 better than the analyst estimate of $1.03. Revenue was $17.12 billion, versus the consensus of $17.08 billion. First quarter comparable sales increased a better-than-expected 2.3 percent, driven by growth in both transactions and basket size.

Equinix (NASDAQ: EQIX) 1.8% LOWER; announced that the U.S. Internal Revenue Service ("IRS") has issued a favorable private letter ruling ("PLR") in connection with Equinix's conversion to a real estate investment trust ("REIT") for federal income tax purposes effective for its taxable year commencing January 1, 2015. The PLR supports Equinix's position with respect to numerous technical tax issues in connection with Equinix's election of REIT status and conversion to a REIT. In the PLR, the IRS addressed and favorably ruled on Equinix's assets and revenue model (including data center assets as qualified REIT assets and interconnection revenues as qualified REIT revenues), its particular items of federal taxable income from global operations, and its transition plans from a C-corporation to a REIT (including proposed distributions to stockholders). In accordance with the previously announced unanimous approval of Equinix's conversion to a REIT by the Board of Directors of Equinix, Equinix began its first day as a REIT on January 1, 2015.



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