Pre-Open Stock Movers 11/29: (CYTR) (VBLT) (THO) Higher; (NVLS) (FOLD) (SCVL) Lower (more...)
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Today's Pre-Open Stock Movers
Nivalis Therapeutics (NASDAQ: NVLS) 53.6% LOWER; announced topline results from the Company's Phase 2 trial evaluating the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg, in adult patients with CF who had two copies of the F508del-CFTR mutation and were being treated with Orkambi. There were no dose limiting toxicities and cavosonstat was well tolerated at all doses in the trial. The trial failed, however, to demonstrate benefit in absolute change in percent predicted FEV1, the trials primary endpoint, or in sweat chloride reduction at 12 weeks.
CytRx Corporation (Nasdaq: CYTR) 32.5% HIGHER; announced positive updated results from its pivotal Phase 3 clinical trial evaluating aldoxorubicin compared to investigator's choice in patients with relapsed or refractory soft tissue sarcomas (STS). The study, which enrolled 433 patients, demonstrated a statistically significant improvement in progression-free survival (PFS) between aldoxorubicin and investigator's choice therapy in 246 patients with leiomyosarcoma and liposarcoma, (p=0.007). The hazard ratio (HR) was 0.62 (95% CI 0.44-0.88), representing a 38% reduction in the risk of tumor progression for patients receiving aldoxorubicin versus investigator's choice. Leiomyosarcoma and liposarcoma are the two most common types of STS and accounted for 57% of the patients enrolled in the trial.
Amicus Therapeutics (Nasdaq: FOLD) 27.2% LOWER; announces its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat for Fabry disease. Following several collaborative discussions with the U.S. Food and Drug Administration (FDA), including the receipt of final written minutes from an in-person Type B meeting, the Company plans to collect additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation.
VBL Therapeutics (Nasdaq: VBLT) 20% HIGHER; announced top-line results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer. As previously announced, this trial met its primary endpoint, which was defined as 25% progression-free survival at 6 months (PFS-6), in heavily-pretreated patients with late-stage disease. A dose-dependent response was seen, with 35% of patients reaching PFS-6 in the therapeutic dose cohort, versus 25% in a low-dose cohort. Given this positive clinical response, the Company continued to follow patients for overall survival (OS) data, which was not a primary endpoint. Although the trial included a small number of patients and was not powered to show OS differences, the new data show a dose-response and evidence of an overall survival benefit in the cohort of patients treated with multiple therapeutic doses of VB-111, compared to patients who received a single low dose of VB-111 (mOS 761 days versus 469 days; p=0.096). Only one patient remained alive in the low-dose cohort, compared to a tail of about 50% in the high dose group.
Shoe Carnival (NASDAQ: SCVL) 12.1% LOWER; reported Q3 EPS of $0.54, $0.02 worse than the analyst estimate of $0.56. Revenue for the quarter came in at $274.5 million versus the consensus estimate of $278.33 million. Comps declined 0.4%. GUIDANCE: Shoe Carnival sees FY2016 EPS of $1.46-$1.51, versus the consensus of $1.60. Shoe Carnival sees FY2016 revenue of $1.00-1.01 billion, versus the consensus of $1.01 billion. comparable store sales increase ranging from approximately 0.5 percent to 0.9 percent.
Thor Industries (NYSE: THO) 10% HIGHER; reported Q1 EPS of $1.49, $0.26 better than the analyst estimate of $1.23. Revenue for the quarter came in at $1.71 billion versus the consensus estimate of $1.5 billion.
Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) 7.9% HIGHER; announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was equivalent between M923 and HUMIRA. The estimated difference in responders was well within the pre-specified confidence interval, confirming equivalence.
Tiffany & Co. (NYSE: TIF) 5.5% HIGHER; reported Q3 EPS of $0.76, $0.08 better than the analyst estimate of $0.68. Revenue for the quarter came in at $949.3 million versus the consensus estimate of $922.6 million. Constant currency comps fell 3 percent, versus a drop of 4.1 percent expected by analysts.
TiVo Corporation (Nasdaq: TIVO) 4.8% HIGHER; Tivo and Netflix (Nasdaq: NFLX) announced they signed licensing agreements that allow both companies to deliver a better entertainment experience to consumers.
AK Steel (NYSE: AKS) 4.8% LOWER; Macquarie downgraded from Outperform to Neutral with a price target of $9.00.
21Vianet Group (NASDAQ: VNET) 4.6% HIGHER; reported Q3 EPS of ($0.13), $0.01 better than the analyst estimate of ($0.14). Revenue for the quarter came in at $145.3 million versus the consensus estimate of $133.55 million.
US Steel (NYSE: X) 4.5% LOWER; Argus downgraded from Buy to Hold
ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) 4.4% HIGHER; announced that the U.S. Food and Drug Administration (FDA) has granted Iclusig (ponatinib) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved in December 2012 under the FDAs accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drugs clinical benefit. The therapy was granted the FDAs orphan drug designation because it is intended to treat a rare disease or condition.
SiteOne Landscape Supply (NYSE: SITE) 4.4% LOWER; announced the launch of an underwritten secondary public offering of 8,000,000 shares of common stock by selling stockholders CD&R Landscape Holdings, L.P., an affiliate of Clayton, Dubilier & Rice, LLC, and Deere & Company. The Company will not receive any proceeds from the sale of shares being sold in this offering. In connection with the offering, the selling stockholders have granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock.
Cotiviti Holdings, Inc. (NYSE: COTV) 4.3% LOWER; announced that certain stockholders of the Company intend to offer 10,000,000 shares of the Company’s common stock, par value $0.001 per share, in an underwritten public offering.
Pandora (NYSE: P) 4.2% HIGHER; unusually activity in call options yesterday. The topic was discussed by Pete Najarian on CNBC's Fast Money.
Texas Capital Bancshares, Inc. (NASDAQ: TCBI) 3.6% LOWER; announced today an underwritten public offering of 3.0 million shares of common stock to the public. The Company expects to close the sale of the shares of common stock on December 2, 2016, subject to customary closing conditions. The underwriters will have a 30-day option to purchase up to an additional 450,000 shares of common stock from the Company.
UnitedHealth Group (NYSE: UNH) 3.4% HIGHER; For 2017, UnitedHealth Group will introduce outlooks for revenues of $197 billion to $199 billion, net earnings of $8.75 to $9.05 per share, and adjusted net earnings of $9.30 to $9.60 per share. This compare to the current consensus of $196.9 billion and $9.15. Cash flows from operations are expected to range from $11.5 billion to $12 billion in 2017.
ZTO Express (NYSE: ZTO) 2.4% HIGHER; reported Q3 EPS of RMB0.78, versus RMB0.34 reported last year. Revenue for the quarter came in at RMB2.35 billion, versus RMB1.41 billion reported last year.
Mallinckrodt (NYSE: MNK) 1.2% LOWER; reported Q4 EPS of $2.04, $0.03 better than the analyst estimate of $2.01. Revenue for the quarter came in at $887.2 million versus the consensus estimate of $880.1 million.
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