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MENLO PARK, Calif., May 22, 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), announced that three-year safety and efficacy results for somavaratan and a comparison of baseline demographics within its Phase 2a and Phase 3 trials were presented during the 19th European Congress of Endocrinology (ECE), May 20 – 23, 2017 in Lisbon, Portugal. “The three-year data from the VISTA study in children with GHD has shown safety and efficacy that is in line with contemporary registry data for daily rhGH,” said Philippe F. Backeljauw, M.D., Professor of Clinical Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center and a somavaratan trial investigator. "Our review of the baseline characteristics across the Phase 2 and Phase 3 pediatric studies showed similar treatment populations. Assuming the response profile is maintained in the Phase 3 VELOCITY study, there may be significant interest in somavaratan for the treatment of pediatric GHD, given the potential to decrease injection burden on patients and enhance adherence with therapy.” The poster entitled “3-Year Safety and Efficacy Update of the VERTICAL & VISTA Trials of Somavaratan (VRS-317), a Long-Acting rhGH, in Children with Growth Hormone Deficiency (GHD),” highlighted safety and efficacy data in 48 patients who completed three years of somavaratan treatment in the Phase 2a VERTICAL study and subsequent VISTA long-term safety study. Mean height velocity (HV) for years 1, 2, and 3, following a dose increase at the beginning of Year 2, was comparable to reported HV for daily rhGH therapy. Height SDS continued to improve over the course of treatment, IGF-I responses achieved the target therapeutic range, and change in bone age compared to chronologic age was consistent with observed changes in published literature for the ANSWER Registry for daily rhGH. Overall, the three-year results support the 3.5 mg/kg twice-monthly dose regimen being used in the ongoing Phase 3 VELOCITY trial. The poster entitled “Achievement of a Suitable Basis of Comparison in Phase 2 and 3 Clinical Trials (VERTICAL/VISTA, and VELOCITY) Comparing Somavaratan vs Daily rhGH for Pediatric Growth Hormone Deficiency (PGHD)” compares the baseline characteristics of the patients in both arms of the Phase 3 VELOCITY trial and patients in the Phase 2a VERTICAL trial. Consistent inclusion/exclusion criteria were used in both trials and a stratification procedure balanced the arms in the Phase 3 non-inferiority trial. This approach yielded patient populations without clinically meaningful differences in baseline characteristics, either within the Phase 3 VELOCITY somavaratan and daily treatment arms or between the VERTICAL and VELOCITY trials. Thus, a valid basis of comparison between treatment populations was achieved. 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, 2016 and in our Quarterly Report on Form 10-Q for the three months ended March 31, 2017, 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.


MENLO PARK, Calif., May 22, 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), announced that three-year safety and efficacy results for somavaratan and a comparison of baseline demographics within its Phase 2a and Phase 3 trials were presented during the 19th European Congress of Endocrinology (ECE), May 20 – 23, 2017 in Lisbon, Portugal. “The three-year data from the VISTA study in children with GHD has shown safety and efficacy that is in line with contemporary registry data for daily rhGH,” said Philippe F. Backeljauw, M.D., Professor of Clinical Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center and a somavaratan trial investigator. "Our review of the baseline characteristics across the Phase 2 and Phase 3 pediatric studies showed similar treatment populations. Assuming the response profile is maintained in the Phase 3 VELOCITY study, there may be significant interest in somavaratan for the treatment of pediatric GHD, given the potential to decrease injection burden on patients and enhance adherence with therapy.” The poster entitled “3-Year Safety and Efficacy Update of the VERTICAL & VISTA Trials of Somavaratan (VRS-317), a Long-Acting rhGH, in Children with Growth Hormone Deficiency (GHD),” highlighted safety and efficacy data in 48 patients who completed three years of somavaratan treatment in the Phase 2a VERTICAL study and subsequent VISTA long-term safety study. Mean height velocity (HV) for years 1, 2, and 3, following a dose increase at the beginning of Year 2, was comparable to reported HV for daily rhGH therapy. Height SDS continued to improve over the course of treatment, IGF-I responses achieved the target therapeutic range, and change in bone age compared to chronologic age was consistent with observed changes in published literature for the ANSWER Registry for daily rhGH. Overall, the three-year results support the 3.5 mg/kg twice-monthly dose regimen being used in the ongoing Phase 3 VELOCITY trial. The poster entitled “Achievement of a Suitable Basis of Comparison in Phase 2 and 3 Clinical Trials (VERTICAL/VISTA, and VELOCITY) Comparing Somavaratan vs Daily rhGH for Pediatric Growth Hormone Deficiency (PGHD)” compares the baseline characteristics of the patients in both arms of the Phase 3 VELOCITY trial and patients in the Phase 2a VERTICAL trial. Consistent inclusion/exclusion criteria were used in both trials and a stratification procedure balanced the arms in the Phase 3 non-inferiority trial. This approach yielded patient populations without clinically meaningful differences in baseline characteristics, either within the Phase 3 VELOCITY somavaratan and daily treatment arms or between the VERTICAL and VELOCITY trials. Thus, a valid basis of comparison between treatment populations was achieved. 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, 2016 and in our Quarterly Report on Form 10-Q for the three months ended March 31, 2017, 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.


MENLO PARK, Calif., May 22, 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), announced that three-year safety and efficacy results for somavaratan and a comparison of baseline demographics within its Phase 2a and Phase 3 trials were presented during the 19th European Congress of Endocrinology (ECE), May 20 – 23, 2017 in Lisbon, Portugal. “The three-year data from the VISTA study in children with GHD has shown safety and efficacy that is in line with contemporary registry data for daily rhGH,” said Philippe F. Backeljauw, M.D., Professor of Clinical Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center and a somavaratan trial investigator. "Our review of the baseline characteristics across the Phase 2 and Phase 3 pediatric studies showed similar treatment populations. Assuming the response profile is maintained in the Phase 3 VELOCITY study, there may be significant interest in somavaratan for the treatment of pediatric GHD, given the potential to decrease injection burden on patients and enhance adherence with therapy.” The poster entitled “3-Year Safety and Efficacy Update of the VERTICAL & VISTA Trials of Somavaratan (VRS-317), a Long-Acting rhGH, in Children with Growth Hormone Deficiency (GHD),” highlighted safety and efficacy data in 48 patients who completed three years of somavaratan treatment in the Phase 2a VERTICAL study and subsequent VISTA long-term safety study. Mean height velocity (HV) for years 1, 2, and 3, following a dose increase at the beginning of Year 2, was comparable to reported HV for daily rhGH therapy. Height SDS continued to improve over the course of treatment, IGF-I responses achieved the target therapeutic range, and change in bone age compared to chronologic age was consistent with observed changes in published literature for the ANSWER Registry for daily rhGH. Overall, the three-year results support the 3.5 mg/kg twice-monthly dose regimen being used in the ongoing Phase 3 VELOCITY trial. The poster entitled “Achievement of a Suitable Basis of Comparison in Phase 2 and 3 Clinical Trials (VERTICAL/VISTA, and VELOCITY) Comparing Somavaratan vs Daily rhGH for Pediatric Growth Hormone Deficiency (PGHD)” compares the baseline characteristics of the patients in both arms of the Phase 3 VELOCITY trial and patients in the Phase 2a VERTICAL trial. Consistent inclusion/exclusion criteria were used in both trials and a stratification procedure balanced the arms in the Phase 3 non-inferiority trial. This approach yielded patient populations without clinically meaningful differences in baseline characteristics, either within the Phase 3 VELOCITY somavaratan and daily treatment arms or between the VERTICAL and VELOCITY trials. Thus, a valid basis of comparison between treatment populations was achieved. 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, 2016 and in our Quarterly Report on Form 10-Q for the three months ended March 31, 2017, 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.


NEWTOWN, Pa.--(BUSINESS WIRE)--Palladio Biosciences, Inc. (Palladio) http://palladiobio.com/, a private biopharmaceutical company founded to develop medicines that make a meaningful impact on the lives of patients with orphan diseases of the kidney, announced today that it has acquired global rights to lixivaptan, a selective vasopressin V2 receptor antagonist, from Chiesi USA, Inc. Palladio will develop lixivaptan for Polycystic Kidney Disease (PKD), an orphan kidney disease for which there are no drug treatments approved in the United States. “We are very pleased to be developing lixivaptan as our first product,” said Lorenzo Pellegrini, Ph.D., Founder and Chief Executive Officer of Palladio. “We believe that lixivaptan may be able to delay the progression of PKD, thus decreasing the need for dialysis and/or kidney transplant and potentially extending the lives of patients with PKD.” In conjunction with the lixivaptan acquisition, Palladio closed on a Series A venture round led by Medicxi, one of Europe’s largest dedicated life sciences venture capital firms. Michele Ollier, MD, Partner and co-founder of Medicxi, and Jonathan Edwards, Ph.D. principal at Medicxi, have joined the Board of Directors of Palladio Biosciences. "We are excited to be supporting Palladio Biosciences," said Michele Ollier, MD. "Lixivaptan represents a late stage, de-risked orphan development program in an area of high unmet need with no treatment approved in the US." "We are pleased to have completed this transaction with Palladio Biosciences in an effort to bring this important medicine to PKD patients worldwide," stated Ken McBean, President and CEO at Chiesi USA, Inc. "As a company focused on developing treatments to address important unmet medical needs, we are glad that Palladio is committed to the development of this product." Lixivaptan is a selective vasopressin V2 receptor antagonist. This mechanism of action has clinical proof of concept to delay the progression of the autosomal dominant form of PKD. Lixivaptan was previously administered to more than 1,600 subjects across 36 clinical studies as part of a prior clinical development program for the treatment of hyponatremia. Palladio expects to leverage this extensive data package and the learnings from recent PKD drug development activities to advance lixivaptan for PKD. PKD is an inherited genetic disease that affects thousands of people in the United States and millions globally. The disease is characterized by uncontrolled growth of fluid-filled cysts in the kidney, which can each grow to be as large as a football. The continued enlargement of cysts and replacement of normal kidney tissue causes irreversible loss of renal function. In the United States, approximately 2,500 new people with PKD require dialysis or a kidney transplant every year, making PKD the 4th leading cause of kidney failure. There is no cure for PKD. Palladio Biosciences is a privately-owned, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney and is located in Newtown, PA. For more information, please visit www.palladiobio.com. Medicxi is a life sciences focused venture capital firm, recently spun out of Index Ventures. One of Europe's largest dedicated life sciences VC firms, Medicxi has offices in London, Jersey and Geneva. Past and existing portfolio companies include for example GenMab (Copenhagen: GEN.CO), PanGenetics (acquired by Abbott), Minerva Neurosciences (Nasdaq: NERV), Egalet (Nasdaq: EGLT), Molecular Partners (Swiss: MOLN. SW), Versartis (Nasdaq: VSAR), Levicept, XO1 (acquired by J&J), MorphogenIX, and Gadeta. For more information, please visit www.Medicxi.com and connect with Medicxi on Twitter and LinkedIn. Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, please visit www.chiesiusa.com. Please note that lixivaptan is for investigational use only.


NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky, LLP announces it has commenced an investigation of Versartis Inc. (NASDAQ:VSAR) concerning possible breaches of fiduciary duty. To obtain additional information, go to: or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972. There is no cost or obligation to you. Levi & Korsinsky is a national firm with offices in New York, Connecticut, California, and Washington D.C. The firm’s attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities lawsuits and have recovered hundreds of millions of dollars for aggrieved shareholders. For more information, please feel free to contact any of the attorneys listed below. Attorney advertising. Prior results do not guarantee similar outcomes.


NEW YORK, NY / ACCESSWIRE / April 26, 2017 / Levi & Korsinsky, LLP announces it has commenced an investigation of Versartis Inc. (NASDAQ: VSAR) concerning possible breaches of fiduciary duty. To obtain additional information, go to: http://zlk.9nl.com/versartis-vsar, or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212) 363-7500, toll-free: (877) 363-5972. There is no cost or obligation to you. Levi & Korsinsky is a national firm with offices in New York, Connecticut, California, and Washington D.C. The firm's attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities lawsuits and have recovered hundreds of millions of dollars for aggrieved shareholders. For more information, please feel free to contact any of the attorneys listed below. Attorney advertising. Prior results do not guarantee similar outcomes.


Rare Diseases affect 30 million people in the United States and 350 million people globally. Despite this size, it lacks a strong unified voice as only 15% of rare diseases have organizations or foundations providing support or driving research, halting the progress that could be made. Mediaplanet’s cross-platform edition of “Rare Diseases” will call upon researchers, universities, students, companies, policy makers, and clinicians to do more research and to make readers aware of the importance of advocating for the rare disease community. Sam Buck, a child fighting VWM, graces the cover of the print publication. Through an exclusive interview with Mediaplanet, his mother Allyson opens up about her families struggle with rare diseases “The pediatrician told us that there’s no treatment, no cure- there’s nothing” Allyson recalls. Allyson shares how to make the best of such a difficult situation, and how to answer an unlucky diagnosis with rare courage. "It does get easier” Allyson shares. The print component of “Rare Diseases” is distributed within the weekend edition of USA Today with a circulation of approximately 750,000 copies and an estimated readership of 1.5 million. The digital component is distributed nationally through a vast social media strategy and across a network of top news sites and partner outlets. To explore the digital version of the campaign, click here. This edition of “Rare Diseases” was made possible with the support of The Buck Family, NORD (National Organization for Rare Disorders), NIH office of Rare Disease Research, Global Genes, C1 Consulting, Alexion Pharmaceuticals, Aegerion Pharmaceuticals, Incyte, Versartis, Fibrocell, Amicus Therapeutics, AmeriSourceBergen, and Illumina. About Mediaplanet Mediaplanet is the leading independent publisher of content marketing campaigns covering a variety of topics and industries such as Health, Education, Lifestyle, Business and Technology, and Corporate Social Responsibility. We turn consumer interest into action by providing readers with motivational editorial, pairing it with relevant advertisers and distributing it within top newspapers and online platforms around the world. Please visit http://www.mediaplanet.com for more on who we are and what we do.


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.


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.

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