GHD

Brisbane, Australia
Brisbane, Australia

Time filter

Source Type

Similar PK/PD data between US and Japanese children treated with somavaratan support using the same dose in the ongoing US and Japan Phase 3 trials MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that a comparison of data from its U.S. and Japanese Phase 2 studies was accepted as a late-breaking poster presentation at the Endocrine Society's 99th Annual Meeting & Expo (ENDO 2017), to be held April 1-4, in Orlando, Florida. The abstract has been published online and is available on the ENDO 2017 website. This is the sixth Versartis abstract that has been accepted for presentation at the conference, including five that were announced previously. Comparison of the pharmacokinetic and pharmacodynamic (PK/PD) properties between U.S. and Japanese pediatric subjects showed similar responses achieved at the same range of somavaratan doses in both populations. In addition, variability between the two patient sets was minor, with no effect on treatment outcomes. These similarities support the utilization of the same 3.5 mg/kg twice-monthly US Phase 3 dose in the ongoing Japanese Phase 3 trial, which has been reviewed with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Below are details on each of the presentations. ORAL PRESENTATION (Oral Session: OR31-1) Monday, April 3, 2017 - 11:15 AM - 12:45 PM 31135 - Safety and Efficacy of Somavaratan (VRS-317), a Long-Acting Recombinant Human Growth Hormone (rhGH), in Children with Growth Hormone Deficiency (GHD): 3-Year Update of the VERTICAL & VISTA Trials (NCT01718041, NCT02068521) POSTER PRESENTATION (Poster Board: SAT 016) Saturday, April 1, 2017 - 1:00 – 3:00 PM 31202 - Achievement of a Suitable Basis of Comparison in Phase 2 and Phase 3 Pediatric Somavaratan Clinical Trials (VERTICAL, VISTA, and VELOCITY Studies) and for the Comparison of Somavaratan to Daily Recombinant Human Growth Hormone (rhGH) POSTER PRESENTATION (Poster Board: SAT 015) Saturday, April 1, 2017 - 1:00 – 3:00 PM 29268 - IGF Family Biomarkers in the Diagnosis of Pediatric Growth Hormone Deficiency (PGHD) in Somavaratan Clinical Trials About Somavaratan Somavaratan is Versartis' investigational, novel, long-acting form of recombinant human growth hormone (rhGH). This fusion protein consists of rhGH and specific sequences of hydrophilic amino acids based on a proprietary XTEN®1 technology. Somavaratan has been designed with the goal of improving therapeutic outcomes for children and adults with growth hormone deficiency (GHD), including enhanced adherence and convenience with a twice-monthly dosing schedule, fine gauge needle autoinjector device and room temperature storage. Somavaratan is currently being evaluated for the treatment of pediatric GHD in the pivotal Phase 3 VELOCITY trial in the U.S., Canada and Europe, for which data are anticipated in September 2017, and the J14VR5 Phase 2/3 trial in Japan. Confirmatory safety and efficacy data from 36 months of dosing in the Phase 2 trial and VISTA long-term safety study are scheduled to be presented during the Endocrine Society 2017 annual meeting. In adult GHD, results have been reported from the Phase 2 VITAL trial in the U.S., Europe and Australia and a Phase 3 trial is expected to begin by the end of 2017. 1XTEN is a registered trademark of Amunix Operating Inc. About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new molecular entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


COPENHAGEN, Denmark, Nov. 16, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs in rare diseases, today announced that the company will hold a conference call and live webcast on Wednesday, November 30, 2016 at 4:30 p.m. Eastern Time (ET) to discuss its third quarter financial results and provide a business update. A webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A replay of the webcast will be available on this website shortly after the conclusion of the call until December 30, 2016. Ascendis Pharma is applying the TransCon technology platform to build a leading rare disease commercial company. The company utilizes its innovative TransCon technology to address significant unmet medical needs in rare diseases by improving clinically-validated parent drugs and creating therapies with potential for best-in-class efficacy, safety and/or convenience. Ascendis Pharma has a wholly-owned pipeline of rare disease endocrinology programs, including once-weekly TransCon Growth Hormone, which is currently being evaluated in the Phase 3 heiGHt Trial for children with growth hormone deficiency (GHD), TransCon PTH, a long-acting prodrug of parathyroid hormone for hypoparathyroidism, and TransCon CNP, a long-acting prodrug of C-Type Natriuretic Peptide for achondroplasia. Additionally, Ascendis Pharma has multi-product collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology. For more information, please visit www.ascendispharma.com. This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our product pipeline, (ii) our ability to apply the TransCon technology platform to build a leading rare disease commercial company, and (iii) our expectations regarding our ability to create therapies with potential for best-in-class efficacy, safety and/or convenience. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug; for planned clinical studies; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Report on Form 6-K filed with the SEC on October 18, 2016. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.


News Article | November 30, 2016
Site: www.prnewswire.co.uk

COPENHAGEN, Denmark, Nov. 30, 2016 /PRNewswire/ -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs in rare diseases, today announced financial results for the three months ended September 30, 2016. "The third quarter was productive and successful as we outlined our Vision 20/20 strategic roadmap, initiated the TransCon Growth Hormone Phase 3 heiGHt Trial, and announced two additional pipeline programs, TransCon Parathyroid Hormone (PTH) and TransCon C-Type Natriuretic Peptide (CNP)," commented Jan Mikkelsen, President and Chief Executive Officer. "We are extremely pleased with this progress as we work towards our goal to become a leading, integrated rare disease company with an initial focus on endocrinology." For the third quarter of 2016, Ascendis Pharma reported a net loss of €18.3 million, or €0.72 per share (basic and diluted) compared to a net loss of €7.3 million, or €0.30 per share (basic and diluted) during the same period in 2015. Research and development costs for the third quarter were €16.5 million compared to €8.0 million in the same period in 2015. Higher R&D costs in the 2016 quarter reflect an increase in manufacturing costs and clinical costs related to the company's Phase 3 heiGHt Trial, as well as support for the company's two new pipeline candidates, TransCon PTH and TransCon CNP. General and administrative expenses for the third quarter were €2.6 million compared to €1.4 million in the same period in 2015. The increase is primarily due to an increase in administrative personnel to respond to increasing compliance requirements of operating as a publicly traded company. As of September 30, 2016, the company had cash and cash equivalents of €74.5 million compared to €90.8 million as of June 30, 2016. Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. ET to discuss its third quarter 2016 financial results. Telephone numbers for the live conference call are (844) 290-3904 (United States) and (574) 990-1036 (International). The access code for all callers is 19791672. The webcast can be accessed on the Investors & News section of the Ascendis Pharma website at www.ascendispharma.com, and will be available for replay until December 30, 2016. Ascendis Pharma is applying the TransCon technology platform to build a leading rare disease commercial company. The company utilizes its innovative TransCon technology to address significant unmet medical needs in rare diseases by improving clinically validated parent drugs and creating therapies with potential for best-in-class efficacy, safety and/or convenience. Ascendis Pharma has a wholly-owned pipeline of rare disease endocrinology programs, including once-weekly TransCon Growth Hormone, which is currently being evaluated in the Phase 3 heiGHt Trial for children with growth hormone deficiency (GHD), TransCon PTH, a long-acting prodrug of parathyroid hormone for hypoparathyroidism, and TransCon CNP, a long-acting prodrug of C-Type Natriuretic Peptide for achondroplasia. Additionally, Ascendis Pharma has multi-product collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology. For more information, please visit www.ascendispharma.com. This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our product pipeline, (ii) our potential to become a leading, integrated rare disease company, (iii) whether TransCon Growth Hormone's Phase 2 study results are indicative of its safety, efficacy and tolerability profile, (iv) our ability to apply the TransCon technology platform to build a leading rare disease commercial company, and (v) our expectations regarding our ability to create therapies with potential for best-in-class efficacy, safety and/or convenience. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug; for planned clinical studies; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Report on Form 6-K filed with the SEC on October 18, 2016. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.


News Article | December 28, 2016
Site: www.businesswire.com

SEONGNAM, South Korea--(BUSINESS WIRE)--Genexine Inc. (KOSDAQ: 095700), a clinical stage biotechnology company developing innovative biologics focused on immuno-oncology and metabolic/autoimmune diseases, today announced that Dr. H. Michael Keyoung, CEO and President of Genexine, will present at the J.P. Morgan 35th Annual Healthcare Conference Emerging Markets Track on January 11th at the Westin St. Francis Hotel, San Francisco. The J.P. Morgan Healthcare Conference is one of the healthcare industry’s biggest events of the year and it brings thousands of investors and executives from around the world to San Francisco. Genexine, Inc., listed on KOSDAQ (095700-KQ) since 2009, is a clinical stage biotherapeutics company focused on immuno-oncology and metabolic/autoimmune diseases. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric GHD, currently in multinational phase II trials. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III and plans to enter into Phase 1b/2a trial in cervical cancer with GX-188E in combination Keytruda (anti- PD-1 therapy) of Merck (also known as MSD) 1H of 2017. Currently Genexine is running over 8 clinical trials from Phase I to Phase IIb in Europe and Asia. In addition to Merck (MSD) collaboration, Genexine has strategic partnerships with leading Asian companies such as Shanghai Fosun Pharma, Tasly Pharma, Kalbe Pharma (largest healthcare Indonesian company), and Korean big Pharma companies such as Green Cross and Yuhan. Founded in 1999, Genexine has over 150 employees and half of them are scientists with MSc or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.


News Article | February 15, 2017
Site: www.businesswire.com

SAN FRANCISCO--(BUSINESS WIRE)--Riverbed Technology, the application performance company, in partnership with global professional services company GHD, announced successful deployment of Riverbed SteelConnect – an app-defined SD-WAN (software-defined wide area network) solution that simplifies networking for the cloud-centric enterprise – to enable the rapid deployment of 50 new offices onto the company’s network, fuelling stronger global collaboration, business agility and reducing global telecom costs by 75%. Tweet This: Riverbed helps @GHDspeaks rapidly provision new sites with SD-WAN solution: http://rvbd.ly/2lswS7X GHD, a leader in engineering, architecture, environmental and construction services, has a complex IT landscape which spans more than 10 countries, 8,500 employees, leverages 3,000 business and technical applications, and includes GHD’s own private cloud. In 2014, GHD merged with North American engineering consultancy Conestoga-Rovers & Associates (CRA), which included the addition of more than 3000 employees in over 100 offices, including 50 small sites. Elizabeth Harper, the Chief Information Officer of GHD, was tasked with integrating all the new offices and their IT systems into the wider GHD business. Some of the new sites were geographically dispersed across the US and Canada, designed to be as close to their clients as possible. At the same time, the new offices needed instant access and connectivity to the GHD network globally so employees can collaborate in real time. Watch Video: GHD CIO on Deploying SteelConnect to Rapidly Connect 50 New Offices Using SteelConnect, GHD dramatically reduced the cost of network design and deployment, and was able to connect all 50 of the smaller offices in four weeks. Harper estimates that if GHD had chosen a traditional networking approach, the project would have taken at least three months to complete. “We did a really thorough assessment of the options in the market and what we found with SteelConnect was a very low, almost zero-touch deployment, said Elizabeth Harper, CIO, GHD. “SteelConnect allows us to preconfigure a device using a cloud portal before delivering it to the physical site. This means that a non-IT person at the small office can follow simple instructions, plug the device in and have everything up and running in minutes instead of days or weeks.” GHD plans to expand the deployment to traditional and larger offices, and estimates SteelConnect will save the business roughly $1 Million (USD) a year. Harper added: “What this technology has done is enable us to cost-effectively connect people who wouldn't have had this type of connectivity in the past, and they now really feel like they’re part of the same organization. They have access to all of our broader systems, and can make a VoIP call to anyone in GHD globally, or collaborate using intensive 3D modelling applications. This has made a tremendous cultural impact.” GHD is also very pleased with how easy SteelConnect is to manage and maintain, along with the ability to use SteelConnect to connect direct into public cloud networks such as Microsoft Azure and AWS. In addition to SteelConnect, GHD has deployed the complete Riverbed Application Performance Platform across its organization in order to enable collaboration between project teams spread across the globe: “GHD’s use of emerging technologies and our ability to respond quickly to client demands is how we differentiate ourselves in the market, and Riverbed has been a trusted strategic partner in our success,” said Harper. “The Riverbed platform has enabled us to optimize our network traffic, given us greater visibility of what's actually happening across our network and application environment so we can continue to achieve great performance, and it’s helped us simplify our branch office implementations – all of which are critical to driving the evolution of our business and our ability to serve our clients.” Riverbed is delivering solutions to help companies transition from legacy hardware to a new software-defined and cloud-centric approach to networking, and improve end user experience, allowing enterprises’ digital transformation initiatives to reach their full potential. The Riverbed Application Performance Platform™ delivers the agility, visibility, and performance businesses need to be successful in a cloud and digital world. By leveraging the Platform, organizations can deliver apps, data, and services from any public, private, or hybrid cloud across any network to any end-point. A key part of the platform, Riverbed SteelConnect™ is a revolutionary application-defined SD-WAN solution that provides an intelligent and simplified approach to designing, deploying and managing distributed networks. SteelConnect is the industry’s first and only product that unifies deployment and orchestration of hybrid WANs (Internet & MPLS), branch networks (LAN & WLAN), and cloud environments, including one-click connectivity to AWS and Microsoft Azure. Riverbed, at more than $1 billion in annual revenue, is the leader in Application Performance Infrastructure, delivering the most complete platform for the hybrid enterprise to ensure applications perform as expected, data is always available when needed, and performance issues can be proactively detected and resolved before impacting business performance. Riverbed enables hybrid enterprises to transform application performance into a competitive advantage by maximizing employee productivity and leveraging IT to create new forms of operational agility. Riverbed’s 28,000+ customers include 97% of the Fortune 100 and 98% of the Forbes Global 100. Learn more at www.riverbed.com. Riverbed and any Riverbed product or service name or logo used herein are trademarks of Riverbed Technology, Inc. All other trademarks used herein belong to their respective owners.


SAN FRANCISCO--(BUSINESS WIRE)--Riverbed Technology, the application performance company, today announced major updates to its SD-WAN offering Riverbed SteelConnect, an app-defined, cloud networking solution that provides an intelligent and simplified approach to designing, deploying and managing distributed networks. As part of today’s announcement, SteelConnect now supports complex enterprise environments and dramatically simplifies the implementation of large-scale SD-WAN deployments in the data center with non-disruptive network integration. Riverbed also announced availability of a new line of SteelHead SD models, which combines SteelConnect and industry-leading WAN optimization into a streamlined single-device solution, providing network-agility and one-click connectivity into Microsoft Azure and AWS for superior app and cloud performance. These announcements follow SteelConnect’s tremendous market momentum, in which the Company has surpassed 300 SD-WAN customers and 1,600 online SteelConnect trials. The cloud continues to grow at a rapid pace, with spending on public cloud services expected to reach $247 Billion in 2017 (up 18 percent from 2016), and $383 Billion by 2020, according to Gartner.1 While there’s been major advancements in cloud computing, cloud storage and cloud apps, traditional networking has been left behind. In fact, Gartner says 50% of cloud deployments will suffer from business-impacting performance issues, requiring extensive network redesign. Watch “Networking for the Cloud Era” Webcast beginning at 11 a.m. PT/2:00 p.m. ET on February 14; in EMEA on February 15 2:00 p.m. GMT/3 p.m. CET; and in APJ on February 15 12:00 SGT/15:00 AEDT “In today’s cloud era, legacy approaches to networking which are hardware-centric, rigid and error-prone are preventing businesses from moving forward,” said Paul O’Farrell, Senior Vice President and General Manager of Riverbed’s SteelConnect, SteelHead, and SteelFusion business units. “Riverbed has redefined networking for the cloud with an SD-WAN solution that is application and software-defined, and delivers unprecedented simplicity and agility. The market has responded with hundreds of customers deploying our SD-WAN solutions to date. With today’s SteelConnect and SteelHead SD launches, Riverbed is taking cloud networking one step further, with a new integrated offering driven by customer demand, and updates that deliver greater scalability, and superior network agility and cloud performance.” Watch Now: Learn how leading global professional services company GHD is using SteelConnect to quickly and cost-effectively connect 50 new offices to their network, and help them save approximately $1 million. Simplifying large-scale SD-WAN deployment. The new SteelConnect SDI-5030 Data Center Gateway Appliances simplify the deployment of SD-WAN for large-scale global networks. While other SD-WAN solutions can require thousands of lines of configuration updates and/or firmware upgrades to core data center routers, SteelConnect benefits from integration with the battle-tested Riverbed Interceptor appliance to non-disruptively integrate and orchestrate SD-WAN and WAN Optimization services into data center networks, with elastic scale and high-availability to support application delivery across thousands of remote locations. Combining SD-WAN and WAN-Optimization capabilities. Riverbed SteelConnect and industry-leading SteelHead WAN optimization work together to exchange application identification and classification information to ensure an end-to-end application-centric solution across the network and into the cloud. This is in contrast to dual-vendor approaches where the fidelity of application identity is compromised as packets transmit between discrete network services. The new line of SteelHead SD models (570-SD, 770-SD & 3070-SD) seamlessly integrates SD-WAN and WAN optimization services into a streamlined single-device offering. By deploying a unified solution combining SD-WAN (SteelConnect) and WAN optimization (SteelHead), enterprises can streamline and simplify their approach to cloud networking, drive network agility and deliver superior performance for on-premises and cloud-based applications with ease. “Even as enterprises embrace cloud computing for increased business agility, network-connectivity issues remain a major challenge,” said Brad Casemore, research director for datacenter networks at IDC. “Riverbed has responded by offering a solution that integrates SD-WAN and WAN optimization so that customers can have unified control and management of both traditional and hybrid-cloud networks. Interestingly, IDC research has found that the top three customer requirements for SD-WAN are security, WAN optimization, and policy control and management. With this announcement, Riverbed has sought to address all three concerns in a single device, while also providing their customers with more flexibility as they evolve their networks.” Continued SteelConnect momentum and innovation. SteelConnect, initially launched as an early access offering in April 2016, is the industry’s first and only product that unifies deployment and orchestration of hybrid WANs, branch networks, and cloud environments, including one-click connectivity to AWS and Microsoft Azure. SteelConnect also enables zero-touch provisioning, allowing an enterprise to set-up a global network and connect to the cloud in minutes, and easy ongoing network management that provides the ability to make network or business/application policy changes with a few clicks of a mouse. Riverbed announced general availability of SteelConnect 2.0 in September 2016 with many new features, including integrated visibility with Riverbed SteelCentral. In January 2017, Riverbed announced a “One-Click” cloud networking solution for secure connectivity to Microsoft Azure cloud networks. Now, Riverbed’s SD-WAN solution boasts seamless platform integration with the market-leading Riverbed SteelHead solution, and streamlined data center integration for large-scale deployments. Riverbed’s 300 SD-WAN customers spans across a wide range of industries globally, including retail, manufacturing, healthcare, professional services, finance, technology, and many more. For more information on Riverbed’s SD-WAN solutions, visit http://www.riverbed.com/sdwan Riverbed, at more than $1 billion in annual revenue, is the leader in Application Performance Infrastructure, delivering the most complete platform for the hybrid enterprise to ensure applications perform as expected, data is always available when needed, and performance issues can be proactively detected and resolved before impacting business performance. Riverbed enables hybrid enterprises to transform application performance into a competitive advantage by maximizing employee productivity and leveraging IT to create new forms of operational agility. Riverbed’s 28,000+ customers include 97% of the Fortune 100 and 98% of the Forbes Global 100. Learn more at www.riverbed.com. Riverbed and any Riverbed product or service name or logo used herein are trademarks of Riverbed Technology, Inc. All other trademarks used herein belong to their respective owners.


MENLO PARK, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the Company is scheduled to present at two upcoming investor conferences. Details are as follows: Audio webcasts of the Company’s presentations will be available on the investor relations section of the Versartis’ website at www.versartis.com.  A replay of the presentation will be available for 90 days. About Versartis, Inc. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults.  Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving adherence and, therefore, treatment outcomes.  For more information on Versartis, visit www.versartis.com.


News Article | February 21, 2017
Site: globenewswire.com

MENLO PARK, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced financial results for the fourth quarter and full year ended December 31, 2016 and provided an update on its clinical development programs. “As we enter a pivotal year for the Company, our achievements in 2016 have positioned us very well,” said Jay Shepard, Versartis’ Chief Executive Officer. “We now have compelling safety and efficacy data from up to three years of somavaratan dosing in pediatric patients, have established a strong alliance with Teijin for commercialization in Japan — one of the largest global markets for GHD — and reinforced our strong financial position which supports somavaratan development beyond near-term data and a planned BLA filing next year.” “We are approaching a number of important milestones in 2017, the most significant of which is the top-line data from our pivotal Phase 3 VELOCITY trial in children with GHD, expected in September. Also during the year, we plan to evaluate pediatric patients switching from daily rhGH to somavaratan, complete enrollment in our Phase 3 pediatric trial in Japan, and initiate a Phase 3 trial in adults with GHD. We are excited about the potential catalysts taking place during the year and look forward to our five presentations scheduled for ENDO 2017 in just a few weeks.” For the fourth quarter ended December 31, 2016, Versartis reported a net loss of approximately $22.1 million, or $0.64 per share, basic and diluted, compared to a net loss for the fourth quarter ended December 31, 2015 of $20.1 million, or $0.69 per share, basic and diluted. Total operating expenses for the quarter ended December 31, 2016 were $22.5 million compared to $20.2 million for the quarter ended December 31, 2015. Research and development (R&D) expenses for the quarter ended December 31, 2016 were $16.7 million, compared to 15.6 million for the quarter ended December 31, 2015. The increase in R&D expenses was primarily due to manufacturing costs to support our ongoing Phase 3 clinical trials for somavaratan, including the Phase 3 VELOCITY pediatric trial and the Phase 3 portion of the Phase 2/3 pediatric GHD trial in Japan. General and administrative (G&A) expenses were $5.8 million for the quarter ended December 31, 2016, compared to $4.6 million for the quarter ended December 31, 2015. The increase in G&A expenses was primarily due to additional fees related to consulting and professional services to support our continued growth. Total operating expenses for the year ended December 31, 2016 were $96.3 million compared to $82.5 million for the year ended December 31, 2015. R&D expenses for the year ended December 31, 2016 were $72.0 million, compared to $60.0 million for the year ended December 31, 2015. The increase in R&D expenses was primarily due to manufacturing and clinical costs related to the Company's Phase 2 and ongoing Phase 3 clinical trials, including the VITAL Phase 2 trial for adults, the VELOCITY global Phase 3 trial and the Phase 2/3 trial of somavaratan in pediatric patients in Japan. G&A expenses were $24.3 million for the year ended December 31, 2016, compared to $22.5 million for the year ended December 31, 2015. The increase in G&A expenses was primarily due to additional fees related to consulting and professional services to support our continued growth, including the work associated with our strategic alliance with Teijin, partially offset by a one-time non-recurring expense of $2.4 million associated with our CEO transition in May 2015. Total operating expenses for the quarter ended December 31, 2016 include non-cash stock-based compensation expense of $2.9 million compared to $2.2 million of non-cash stock-based compensation expense for the quarter ended December 31, 2015. Total operating expenses for the year ended December 31, 2016 include non-cash stock-based compensation expense of $10.9 million, compared to $10.7 million of non-cash stock-based compensation expense for the year ended December 31, 2015, which includes a one-time non-recurring charge of $2.0 million associated with our CEO transition. Cash, cash equivalents, and short-term investments were $201.2 million as of December 31, 2016. Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing somavaratan, a novel, long-acting form of recombinant human growth hormone in late-stage clinical trials for the treatment of GHD in children and adults. Somavaratan is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. For more information on Versartis and Versartis sponsored clinical trials, visit www.versartis.com. This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of somavaratan. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on somavaratan; somavaratan being a new molecular entity; the risk that somavaratan may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that somavaratan may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing somavaratan; if somavaratan is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2015 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2016, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Scope of the Report: Report mainly focus on Human Growth Hormone in Worldwide market, especially report covers Human Growth Hormone market like, in North America, Human Growth Hormone market in Europe, Human Growth Hormone market in Asia-Pacific, Human Growth Hormone market in Latin America, Middle as well as Africa. This report categorizes the Human Growth Hormone market based on manufacturers, regions, type and Human Growth Hormone market application. Market Segment by Applications, can be divided into 1. Growth Hormone Deficiency (GHD) 2. Turner Syndrome 3. Chronic Renal Insufficiency 4. Prader Willi Syndrome 5. Small for Gestational Age 6. SHOX Deficiency 7. Other Market Segment by Regions, regional analysis covers 1. Human Growth Hormone Market in North America (USA, Canada and Mexico). 2. Europe Human Growth Hormone Market(Germany, France, UK, Russia and Italy). 3. Human Growth Hormone Market in Asia-Pacific (China, Japan, Korea, India and Southeast Asia). 4. Latin America Human Growth Hormone Market, Middle and Africa. Global Human Growth Hormone market report covers Manufacturers Profiles with their Business Overview which also includes Human Growth Hormone Type and Applications, Human Growth Hormone Sales, Price, Revenue and Human Growth Hormone Market Share. This report also includes Global Human Growth Hormone Market Competition, by Manufacturer, Human Growth Hormone Sales and Market Share by Manufacturer. Global Human Growth Hormone Sales as well as Human Growth Hormone Revenue by Regions (2011-2016) Get Instant Access To the Human Growth Hormone Market Report: https://market.biz/report/global-human-growth-hormone-market-gir/21988/ Report on (Worldwide Human Growth Hormone Market) mainly covers 10 Chapters to deeply display the global Human Growth Hormone market. Chapter 1, to analyze the Human Growth Hormone market’s top manufacturers, with sales, Human Growth Hormone market revenue, and price of Human Growth Hormone , in 2015 and 2016; Chapter 2, to display the Human Growth Hormone market’s competitive situation among the top manufacturers, with Human Growth Hormone market sales, revenue and Human Growth Hormone market share in 2015 and 2016; Chapter 3, to show the global Human Growth Hormone market by regions, with sales, Human Growth Hormone revenue and market share of Human Growth Hormone , for each region, from 2011 to 2016; Chapter 4, 5, 6 and 7, to analyze the key regions, with Human Growth Hormone market sales, revenue and share by key countries in these regions Human Growth Hormone Market scenario; Chapter 8 and 9, to show the Human Growth Hormone market by type and application, with sales Human Growth Hormone market share and growth rate by type, Human Growth Hormone market application, from 2011 to 2016. Chapter 10, Global Human Growth Hormone market forecast, by regions, type and application, with Human Growth Hormone market sales and revenue, from 2016 to 2021.


News Article | February 27, 2017
Site: www.marketwired.com

NOT FOR DISSEMINATION IN THE US OR THROUGH US NEWSWIRE SERVICES Neo Lithium Corp. ("Neo Lithium" or the "Company") (TSX VENTURE: NLC) today announced that it has engaged GHD Chile SA ("GHD"), a leading full-service engineering services firm with offices throughout Latin America to complete the Preliminary Economic Assessment report ("PEA") for the Tres Quebradas lithium brine project ("3Q Project") in Argentina. GHD is a very well recognized firm with a solid track record in servicing analysis for the design and construction requirements for some of the world's largest and lowest cost lithium-potash brine processing facilities situated in Chile and Argentina. The Company is excited to announce that the PEA is expected to be completed well ahead of schedule with a target completion date during the third quarter of 2017. The PEA will provide a detailed financial model and economic analysis for a conventional evaporation recovery circuit for lithium and potash and should lay the foundation for the future feasibility work. "I am delighted with the engagement with GHD and we look forward to working together on maintaining the pace of progress at the 3Q Project," said Waldo Perez, CEO of Neo Lithium "We are proud of our rapid progress and accomplishments in a very short period of time and anticipate that the delivery of a robust economic model by GHD ahead of schedule will enable us to quickly move towards the completion of our feasibility work in 2018. Should the results of the PEA and subsequent mining studies support the development and construction, our objective is to be in production no later than 2021 to capture the strong growth being forecasted for the industry." The Neo Lithium and GHD teams combined include some of the world's highly regarded consulting engineers, geologists and scientists, such as: The engineering and lithium brine processing studies completed to date have laid a strong foundation for the 3Q Project PEA and will allow Neo Lithium to complete the PEA in Q3 2017, well ahead of originally planned. The Company has made significant progress to-date on several fronts at the 3Q Project including: environmental impact approval, detailed sampling completion, road and camp construction, geophysics, initiation of drilling and environmental and community baseline studies. This multi-pronged approach will facilitate timely delivery of the PEA and related NI 43-101 report in due course and ahead of schedule. Neo Lithium Corp. is quickly becoming a prominent new name in lithium brine exploration by virtue of its quality 3Q Project and experienced team. Already well capitalized, Neo Lithium is rapidly advancing its newly discovered 3Q Project -- a unique high-grade lithium brine lake and salar complex in the Latin America's Lithium Triangle. The 3Q Project is located in the Province of Catamarca, the largest lithium producer in Argentina. The project covers approximately 35,000 ha and the salar complex within this area is approximately 160 km2. Surface exploration results indicate a high-grade lithium target in the northern portion of the salar complex extending for approximately 20 by 5 km with low magnesium and sulphate impurities. Low impurities are a key factor in traditional low cost evaporation techniques for final lithium carbonate production. Hot springs on the property with elevated lithium content are part of the recharge system of the salar complex. The technical team that discovered this unique salar complex is one of the most experienced in lithium salars, having discovered and led the technical work, including resource definition and full feasibility study that established the Cauchari lithium salar as the third largest lithium brine resource in the world. Additional information regarding Neo Lithium Corp. is available on SEDAR at www.sedar.com under the Company's profile and at its website at www.neolithium.ca, including various pictures of ongoing work at the project. Waldo Perez, Ph.D, P.Geo., the CEO and President of Neo Lithium Corp. is the Qualified Person who approved the scientific and technical disclosure in the news release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. The TSX Venture Exchange Inc. has in no way approved nor disapproved the contents of this press release. Forward Looking Statements - Certain information set forth in this news release may contain forward-looking statements. Such statements include but are not limited to, statements as to lithium brine grades at depth being consistent with surface results, the potential of the northern salar sediments for hosting brine, continued positive drilling results and the timing for planned resource estimation work, and that test results are indicative of future results . Generally, forward-looking statements can be identified by the use of words such as "plans", "expects" or "is expected", "scheduled", "estimates" "intends", "anticipates", "believes", or variations of such words and phrases, or statements that certain actions, events or results "can", "may", "could", "would", "should", "might" or "will", occur or be achieved, or the negative connotations thereof. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company, which could cause the actual results, performance or achievements of the Company to be materially different from the future results, performance or achievements expressed or implied by such statements. These risks include, without limitation, risks related to failure to obtain adequate financing on a timely basis and on acceptable terms, political and regulatory risks associated with mining and exploration activities, including environmental regulation, risks and uncertainties relating to the interpretation of drill and sample results, risks related to the uncertainty of cost and time estimation and the potential for unexpected delays, costs and expenses, risks related to metal price fluctuations, the market for lithium products, and other risks and uncertainties related to the Company's prospects, properties and business detailed elsewhere in the Company's disclosure record. Although the Company believes its expectations are based upon reasonable assumptions and has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended and undue reliance should not be placed on forward-looking statements.

Loading GHD collaborators
Loading GHD collaborators