5:30 am Prima Biomed receives positive Scientific Advice from the EMA on the development path for its lead product, IMP321 in metastatic breast cancer (PBMD) : After dialogue between Prima and the EMA, the Agency has now confirmed in writing its endorsement of the development program of IMP321 in metastatic breast cancer. The planned Phase IIb study, to be called AIPAC (Active Immunotherapy PAClitaxel) is considered well designed by the Agency. AIPAC is now expected to initiate in Europe during the 4th quarter of 2015. While the EMA never endorses any statement on the likelihood of future regulatory decisions, the Agency's communication has suggested that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study.
- After a smaller safety run-in phase that will extend into 2016 and will yield valuable safety, pharmacokinetic and pharmacodynamic data, AIPAC will proceed to recruit around 200 patients with HER-2 negative metastatic breast cancer, randomising them 1:1 to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321. The trial will have Progression-Free Survival as its Primary Endpoint, with response rates according to the RECIST criteria and Overall Survival among the secondary endpoints. The study has been powered to show a four-month PFS advantage for the treatment group1.
- Allowing time for patient recruitment and follow-up, AIPAC's expected duration is around three years.
4:34 am Mazor Robotics receives 7 purchase orders for its Renaissance Systems in Q2 (MZOR) : Co announced that it received purchase orders for and delivered seven Renaissance systems and one system upgrade in the second quarter ended June 30, 2015.
- Six of the systems were delivered to U.S. hospitals and one was delivered to Spain.
- The Company ended the quarter with 93 Renaissance systems installed globally, with 53 in the U.S., the Company's primary growth market, compared with 72 and 39 systems for the second ended June 30, 2014, respectively.
3:38 am Israel Chemical resumes production of polymeric flame retardant following end of labor strike (ICL) : Co announced that its ICL Industrial Products segment has resumed commercial production of its FR-122P polymeric flame retardant following the end of a labor strike at its 10,000 MT/year plant in Israel. ICL IP also produces FR-122P at a 2,400 MT/year plant in the Netherlands.
- ICL IP also announced today that it is ceasing production and phasing out sales of its HBCD product, FR-1206, excluding sales based on existing commitments to customers, and in line with the phase out dates of REACH and POP legislation.
3:32 am Travelport Worldwide acquires privately held Mobile Travel Technologies; terms not disclosed (TVPT) : Travelport Worldwide has acquired Mobile Travel Technologies, a private company based in Dublin, Ireland.
- MTT provides an industry-leading mobile travel platform and product set that allows airlines, hotels, corporate travel management companies and travel agencies to engage with their customers through sophisticated, tailored mobile services including apps, mobile web and intelligent mobile messaging.
3:15 am On The Wires (:WIRES) :
- NVIDIA (NVDA) announced updates to its GPU-accelerated deep learning software that will double deep learning training performance. The new software will empower data scientists and researchers to supercharge their deep learning projects and product development work by creating more accurate neural networks through faster model training and more sophisticated model design.
- KKR (KKR) together with Hines Italia Value Added Fund, a fund managed by Hines Italia SGR, and COIMA, announced the acquisition of five telecom assets leased to Telecom Italia (TI). The portfolio has a total area of 35,500 square metres. It consists of five separate sites, in Rome, Monza, Parma, San Remo and Pavia.
2:20 am On The Wires (:WIRES) :
- Spok (SPOK) announced that it has partnered with Thailand-based medical distributor Xovic to enable healthcare organisations to improve efficiency and safety with better staff communications. Through this partnership, Xovic distributes Spok's clinical alerting and secure smartphone messaging solutions to hospitals in Thailand.
- Constellium N.V. (CSTM) announced that it has formed a partnership with STELIA Aerospace and CT INGENIERIE to engage in a research and development project called FAST, focused on topological optimization of aero structures and additive manufacturing, also known as 3D printing.
1:13 am Silver Wheaton receives CRA Proposal Letter; does not require the Company to pay any amount to the CRA at this time. (SLW) : Co announces that it has received a proposal letter dated July 6, 2015 from the Canada Revenue Agency in which the CRA is proposing to reassess Silver Wheaton under various rules contained in the Income Tax Act.
- The Proposal outlines CRA's position that the transfer pricing provisions of the Income Tax Act relating to income earned by our foreign subsidiaries outside of Canada should apply such that the income of Silver Wheaton subject to tax in Canada should be increased for the 2005 to 2010 taxation years by approximately C$715 million ($567 million). The issuance of the Proposal does not require the Company to pay any amount to the CRA at this time.
- Management believes that the Company has filed its tax returns and paid applicable taxes in compliance with Canadian tax law.
- Silver Wheaton intends to vigorously defend its tax filing positions and is now in the process of preparing its response to the Proposal.
1:08 am On The Wires (:WIRES) :
- Banc of California, N.A., a wholly owned subsidiary of Banc of California (BANC), and Americas United Bank announced a definitive agreement for Americas United Bank, a minority-owned financial institution, to purchase two branch locations from Banc of California, N.A. The branches are located in Commerce and Santa Fe Springs, California.
- Woodside Energy and OneSubsea, a Cameron (CAM) and Schlumberger (SLB) company, jointly announce that OneSubsea has been awarded a front-end engineering and design contract for the proposed Woodside-operated Browse FLNG Development offshore northwest Australia.
12:58 am CenterPoint will pay additional interest on its 2.0% Zero-Premium Exchangeable Subordinated Notes due 2029 (CNP) : Additional Interest of $1.4520600 per ZENS note will be paid on July 24, 2015 to holders of record as of the close of business on July 10, 2015, and Additional Interest of $0.8206900 per ZENS note will be paid on July 28, 2015 to holders of record as of the close of business on July 14, 2015.
12:49 am Euronet acquires XE to enhance its Money Transfer Business (EEFT) : Euronet Worldwide announced it has acquired XE, a digital foreign exchange information co.
- Euronet will use approximately $60 million from its revolving credit agreement together with approximately 640,000 Euronet shares and an undisclosed amount of cash to complete the acquisition.
- XE's foreign currency payments are currently processed through a vendor, and Euronet expects XE's annual revenue of approximately $10 million to improve to ~$22 million once the payments processing is converted to Euronet's platform at HiFX.
12:45 am BDCA Venture encourages stockholders to vote on the WHITE proxy card for all co's director nominees (BDCV) :
12:41 am SAExploration Holdings completes first major deep water ocean-bottom marine seismic project a week ahead of schedule (SAEX) : Co announced that it has successfully completed its first major deep water ocean-bottom marine seismic project. The project, which was located in Southeast Asia and utilized an advanced remotely operated vehicle deployment method at water depths reaching 1,100 meters, was completed over a week ahead of schedule, leading to meaningful cost savings for the customer. Superior planning and project execution led to enhanced performance despite the challenging and complex operating conditions.