Pre-Open Stock Movers 10/13: (OCUL) (ESRP) (ULTA) Higher; (FLDM) (TGTX) (MELI) Lower (more...)

October 13, 2016 9:20 AM EDT

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Today's Pre-Open Stock Movers

ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV) 30.6% HIGHER; reported positive interim data for CMX157, the Company's highly potent prodrug of tenofovir, from its ongoing Phase 2a multiple ascending dose clinical study. The head-to-head study is the first evaluation of CMX157 in HBV patients, and directly compares CMX157 to tenofovir disoproxil fumarate (TDF, Gilead's Viread®) in chronically infected hepatitis B (HBV) patients.

Ocular Therapeutix (NASDAQ: OCUL) 24.9% HIGHER; entered into a strategic collaboration, option and license agreement with Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN). Ocular and Regeneron will collaborate on thedevelopment of a sustained release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept for the treatment of wet age-related macular degeneration (wet AMD) and other serious retinal diseases.

Fluidigm Corporation (NASDAQ: FLDM) 18.4% LOWER; announced preliminary revenue for the third quarter ended September 30, 2016. Estimated total revenue for the third quarter of 2016, based on managements preliminary analysis, was approximately $22.2 million, a decrease of 23% from $28.6 million in the third quarter of 2015. In the third quarter, instrument revenue fell short of expectations and was approximately $9.2 million, representing a decline of 39% compared to the year ago period. The shortfall versus expectations in instrument revenue was driven primarily by lower-than-expected sales of Helios systems. These financial results are preliminary and subject to completion of our financial statements for the quarter ended September 30, 2016 and the review of those financial statements by our independent registered public accounting firm. (Streets sees Q3 revenue of $29.25 million)

TG Therapeutics, Inc. (Nasdaq: TGTX) 15.2% LOWER; announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial.

OncoGenex Pharmaceuticals, Inc. (Nasdaq: OGXI) 15.2% LOWER; announced results from the final analysis of the Phase 3 ENSPIRIT trial of custirsen in patients whose non-small cell lung cancer (NSCLC) has progressed following initial treatments. The trial did not meet the primary endpoint of demonstrating a statistically significant improvement in overall survival for patients treated with custirsen in combination with docetaxel compared to docetaxel alone. The median overall survival for the custirsen arm was 9.0 months versus 7.9 months for the control arm with a hazard ratio of 0.915 (one-sided p=0.178). Safety results were consistent with those observed in previous trials of custirsen in combination with chemotherapy.

Esperion Therapeutics, Inc. (Nasdaq: ESPR) 7.6% HIGHER; announced the bempedoic acid global pivotal Phase 3 LDL-C lowering clinical development program will include patients with hypercholesterolemia on any statin at any dose based on positive top-line results from its Phase 2 pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase 1 and Phase 2 studies. Top-line results from 1002-035 demonstrated the eight-week study met its primary endpoint of greater LDL-C lowering from baseline of 22 percent (p=0.0028) with bempedoic acid 180 mg compared with placebo with all patients on a background of atorvastatin 80 mg. Bempedoic acid also demonstrated an incremental reduction of 35 percent (p=0.0020) in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid added to atorvastatin 80 mg produced no clinically relevant effects on atorvastatin PK, and appeared to be safe and well-tolerated, with no serious adverse events reported.

Cara Therapeutics (NASDAQ: CARA) 7% HIGHER; H.C. Wainwright initiates coverage with a Buy rating and a price target of $20.00.

Neptune Technologies & Bioressources Inc. (NASDAQ: NEPT) 6.9% HIGHER; Q2 revenues reached $11.6 million, up 165% versus last year.

MercadoLibre, Inc. (Nasdaq: MELI) 6.7% LOWER; announced today that it is commencing an underwritten public offering of shares of its common stock offered by its existing stockholders, eBay Inc., and eBay’s subsidiary, eBay International Treasury Center S.à r.l.. MercadoLibre will not receive any proceeds from the sale of the shares by the Selling Stockholders.

Deckers Outdoor (NYSE: DECK) 5.2% LOWER; Susquehanna downgraded from Neutral to Negative with a price target of $49.00 (from $59.00).

Seattle Genetics (NASDAQ: SGEN) 4% LOWER; filed a registration with the U.S. SEC to sell up to 44,059,594 shares of common stock on behalf of selling shareholders - Baker Bros.

Insys Therapeutics, Inc. (Nasdaq: INSY) 4% LOWER; announced that its preliminary estimated revenues from Subsys (fentanyl sublingual spray) for the third quarter of 2016 will be in the range of $54 million to $55 million. The Company believes it will be cash-flow positive at this level of sales and will be able to meet its overall objectives of new product development and future growth. (NOTE: The Street is looking for total Q3 revenue of $63 million from Insys.)

GoPro (NASDAQ: GPRO) 3.9% LOWER; Piper Jaffray notes it is not currently shipping to Amazon

Winnebago Industries (NYSE: WGO) 3.7% LOWER; reported Q4 EPS of $0.49, $0.02 better than the analyst estimate of $0.47. Revenue for the quarter came in at $263.3 million versus the consensus estimate of $252.52 million.

Hortonworks (NASDAQ: HDP) 3.5% LOWER; Goldman Sachs downgraded from Buy to Sell with a price target of $7.00 (from $13.00).

Penske Automotive Group (NYSE: PAG) 3% LOWER; Evercore ISI downgraded from Hold to Sell.

Ulta Beauty (Nasdaq: ULTA) 2.9% HIGHER; For the third quarter of fiscal 2016, the Company now expects comparable sales, including e-commerce sales, to increase 14% to 15%, compared to previous guidance of 11% to 13%. The Company reported a comparable sales increase of 12.8% in the third quarter of fiscal 2015. Income per diluted share for the third quarter of fiscal 2016 is estimated to be in the range of $1.35 to $1.38, compared to prior guidance of $1.25 to $1.30. The Company reported income per diluted share for the third quarter of fiscal 2015 of $1.11. *** The Street sees Q3 EPS of $1.30.

eBay (NASDAQ: EBAY) 1.5% HIGHER; sells stake in MercadoLibre

Pfizer (NYSE: PFE) 1.5% LOWER; Jefferies downgraded from Buy to Hold with a price target of $36.00 (from $39.00), saying key drivers have played out.

CSX Corp. (NASDAQ: CSX) 1% HIGHER; reported Q3 EPS of $0.48, $0.03 better than the analyst estimate of $0.45. Revenue came in at $2.71 billion, versus the Street consensus of $2.69 billion.

Wells Fargo's (NYSE: WFC) 0.5% HIGHER; embattled Chairman and CEO John Stumpf will retire and step down, effective immediately. President and COO Tim Sloan will takeover as CEO.



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