6:40 am S&P futures vs fair value: flat. Nasdaq futures vs fair value: flat. :
6:40 am European Markets : FTSE...6311.57...+6.90...+0.10%. DAX...8128.43...+33.00...+0.40%.
6:40 am Asian Markets : Nikkei...12686.52...+241.10...+1.90%. Hang Seng...20969.14...+82.10...+0.40%.
6:32 am Alimera Sciences announces issuance of a positive appraisal recommendation on ILUVIEN for consultation in the United Kingdom (ALIM) : Co announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence (NICE) has issued a positive Appraisal Consultation Document (:ACD) on ILUVIEN for the treatment of pseudophakic patients with chronic diabetic macular edema considered insufficiently responsive to available therapies. The ACD recommends a change to the published guidance issued by NICE on January 29, 2013, and takes into consideration a simple patient access scheme that was submitted by Alimera for rapid review. The NICE Appraisal Committee has reconfirmed ILUVIEN's clinical effectiveness in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In the ACD, the Appraisal Committee reiterated "that the technology had been shown to meet a clinical need in people whose disease is unresponsive to available therapies." Additionally, the committee noted that, based on the PAS, the cost-effectiveness threshold has been met for a subgroup of chronic DME patients who are pseudophakic, or have already undergone cataract replacement surgery.
6:30 am Uroplasty will delay the filing of its Form 10-K for the year ended March 31, 2013; CFO place on administrative leave pending completion of the internal control review (UPI) : Co announces that it will delay the filing of its Annual Report on Form 10-K for the year ended March 31, 2013, until the completion of a review of its internal control over financial reporting.
In connection with a review of employee expense reimbursements conducted after the end of the fiscal year, the Co uncovered limited issues related to the internal controls surrounding the employee expense reimbursement approval process. The Co preliminarily concluded that these issues were unlikely to materially affect its financial statements. However, as a result of this review, the Co later uncovered issues in internal control related to the recognition of orders and the payment of sales commissions at the end of fiscal quarters. The Co concluded that further review was advisable.
Based upon facts available, the Co does not currently believe that a material revision of its previously released earnings is likely. However, the review of internal control issues has not been completed and the Co is unable at this time to fully assess the potential impact on its financial statements.
The co has placed Mahedi Jiwani, its Chief Financial Officer, on administrative leave pending completion of the internal control review.
6:16 am Corvel enters into pre-arranged stock trading plan to spend up to $14 mln to repurchase shares of its common stock commencing June 26, 2013 through Aug 21, 2013 (CRVL) :
6:10 am Celgene oral Apremilast achieves statistical significance for primary and secondary endpoints in a Phase II Trial in patients with Behcet's disease (CELG) : Co announces results from a randomized, placebo-controlled phase II trial in patients with Beh?et's disease. The co announced statistical significance for the primary endpoint of the mean number of oral ulcers at week 12 evaluating the Company's novel, oral small-molecule inhibitor of phophodiesterase 4 in patients with Behcet's disease. The complete response rate at week 12 was also statistically significant (APR, 71%; PBO, 29%). Statistically significant and clinically meaningful responses were demonstrated across all secondary endpoints, including all patient-reported outcomes. Notably, improvement in oral ulcer pain was significantly higher with apremilast than with placebo (-44.7 vs -16.0). Among the patients with genital ulcers at baseline, all 10/10 receiving APR had a complete response at week 12 vs 50% (3/6) receiving PBO.
6:03 am Astex Pharma announces presentation of updated results of SGI-110-01 study in patients with intermediate or high risk relapsed or refractory myelodysplastic syndromes; results confirm clinical activity of the novel hypomethylating agent SGI-110 in intermediate or high risk mds patients previously treated with azacitidine or decitabine (ASTX) : Co announced that updated clinical results of its novel hypomethylating agent, SGI-110, were presented in a poster session at the 18th Congress of the European Hematology Association being held June 13-16, 2013 in Stockholm, Sweden.
The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation phase 1 part of the SGI-110-01 study. The study enrolled 15 intermediate or high risk MDS patients including chronic myelomonocytic leukemia who were heavily pretreated with a median number of prior regimens of 2. All 15 patients had received prior azacitidine or decitabine, and 40% of them previously received both agents.
Of the 15 patients, six achieved a clinical response (4 patients with hematological improvement or HI, and 2 patients with marrow CR or mCR) for an overall response rate of 40% (95% CI of 16-68%). The median duration of response was 92 days (range 28-126 days). The two mCR patients received prior treatment with both azacitidine and decitabine, and they demonstrated pronounced DNA demethylation of >10% as measured by the LINE-1 assay (19% and 38% demethylation of LINE-1). SGI-110 subcutaneous treatment was well tolerated. The most common adverse events were injection site pain (mostly Grade 1), and myelosuppression.
6:01 am China Sunergy announced that it has begun shipping solar modules from its plant in Istanbul, Turkey (CSUN) : Co announced that it has begun shipping solar modules from its plant in Istanbul, Turkey, and will deliver a total of ~6.4MW from mid-June to August 2013 to a well-known French customer.
Co currently has a total production capacity of 100MW in solar cells and 300MW in solar modules at its Turkey facility. Being the Company's second largest production base, the plant will enhance the Company's global production chain and efficiently serve customers across Europe and globally.
6:00 am Basic Energy Services reported selected operating data for the month of May 2013; Basic's well servicing rig count remained unchanged at 425 (BAS) : Co reported selected operating data for the month of May 2013. Basic's well servicing rig count remained unchanged at 425. Well servicing rig hours for the month were 75,000 producing a rig utilization rate of 70%, compared to 72% in both April 2013 and May 2012.
During the month, Basic's fluid service truck count remained unchanged at 974. Fluid service truck hours for the month were 194,300 compared to 188,800 and 189,100 in April 2013 and May 2012, respectively. Drilling rig days for the month were 292 producing a rig utilization of 78%, compared to 75% and 96% in April 2013 and May 2012, respectively.
4:52 am Inovio Pharma's Universal H7N9 DNA vaccine generates first protective antibody responses against virulent H7N9 Virus in 100% of vaccinated animals (INO) : Co announces that in a preclinical study of its influenza DNA vaccine against the newly emergent, virulent H7N9 flu virus it achieved immune response levels exceeding what are considered protective levels in other common influenza subtypes. Interim results from a study in mice in a collaboration with researchers from the University of Pennsylvania and Canada's National Microbiology Laboratory in Winnipeg demonstrated that Inovio's H7N9 influenza DNA vaccine achieved greater than 1:40 hemagglutination inhibition in 100% of tested animals, with a geometric mean HAI titer of 1:130 against the A/Anhui/1/13 strain of H7N9 virus. HAI titers at or above 1:40 are considered to denote protection against the influenza virus in humans. These mice received just two vaccinations three weeks apart and the samples tested were from week 5.
In the preclinical study Inovio researchers constructed a consensus DNA vaccine targeting the HA influenza antigen from sequences collected from several infected H7N9 patients to be broadly protective against all H7N9 viruses.
1:56 am Williams Cos confirms one fatality at explosion at Gelsmar, LA plant (WMB) : Co confirms that one person died in an explosion and fire this morning at its Geismar, La. facility.
In addition, the co is closely monitoring the status of one employee and seven contractors who remain hospitalized and are being treated for injuries. The fire has been extinguished and Williams is cooperating with federal, state and local agencies in assessing the situation and determining the cause of the explosion. The extent of damage is unknown at this time.
1:53 am Copa Holdings reports May system wide traffic increased 23.6% YoY (CPA) : Co releases preliminary passenger traffic statistics for May 2013.
- For the month of May 2013, Copa Holdings' system-wide passenger traffic (RPM) increased 23.6% year over year, while capacity increased 18.8%. As a result, system load factor for May 2013 was 75.3%, a 2.9 percentage point increase when compared to May 2012.
- International passenger traffic grew 24.6%, while capacity increased 20.0%. This resulted in a load factor of 75.3%, a 2.8 percentage point increase when compared to May 2012. For the month, International capacity represented 96.5% of total capacity.
- Domestic traffic, represented wholly by Colombian domestic service, increased 0.5%, while capacity decreased 7.3%. As a result, domestic load factor for the month increased 5.8 percentage points to 74.8%. For the month, domestic capacity represented 3.5% of total capacity.
1:51 am Himax Tech prices 22,086,742 ADSs at $5.25 per ADS by selling shareholder Innolux Corp (HIMX) :
1:45 am Laredo Petroleum names Jay Still as President and COO (LPI) : Co announces it has named Jay Still as President, Chief Operating Officer and a member of the co's Board, effective July 8, 2013. Still, who recently resigned his position as Executive Vice President, Domestic Operations at Pioneer Natural Resources, will replace Jerry Schuyler who will retire from the co in 2014. Schuyler has agreed to be available to the co for consultation until his retirement to ensure a smooth transition.
1:41 am S&W Seed provides updates on recent acquisitions' financials (SANW) : Co announces the filing of a Form 8-K/A containing historical financial information and pro forma combined financial statements relating to S&W's April 1, 2013 acquisition of Seed Genetics International and S&W's October 1, 2012 acquisition of Imperial Valley Seeds.
Co states: "The integration of SGI is going well. The Australian harvest has come in much better than we originally estimated and should be a driver for revenues and profits throughout the fourth quarter and next fiscal year. Additionally, we are progressing on a number of the important strategic initiatives that will drive increased value for years to come, including the creation of new blended products and the conversion of acreage located in Australia to S&W's leading varieties which should drive enhanced margins. We are also making strides in our seed breeding program as the expertise of these two organizations comes together...."
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