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News Article | July 27, 2017
Site: globenewswire.com

MENLO PARK, Calif., July 27, 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 second quarter ended June 30, 2017, and provided an update on its clinical development programs. “This is a time of tremendous excitement for Versartis as we approach our most significant milestone to date: the topline results from our Phase 3 VELOCITY trial of somavaratan in pediatric GHD patients,” said Jay Shepard, Chief Executive Officer of Versartis. “With our last patient visits expected in late August, we anticipate topline results around the end of September. Our confidence in somavaratan is supported by three years of data suggesting a solid safety profile and efficacy comparable to U.S. registries on the key parameters, as well as baseline characteristics in our VELOCITY trial arms that are well balanced and in line with our Phase 2 patient population. We look forward to reporting the trial outcome in the very near future, as we continue our work to prepare a strong regulatory package for submission to the U.S. Food and Drug Administration.” “Adding to this excitement is the enthusiasm we are experiencing at clinical trial sites participating in VISTA,” continued Mr. Shepard. “Through our ongoing dialogue with physicians, patients and advocacy groups, we recognize the burden of daily rhGH injections and the desire for less frequent dosing. By expanding enrollment in our VISTA study, we are increasing the overall number of pediatric patients treated with twice-monthly somavaratan while also collecting ‘real world’ data that will be valuable to physicians and patients if approved.” For the second quarter ended June 30, 2017, Versartis reported a net loss of approximately $36.6 million, or $1.04 per share, basic and diluted, compared to a net loss for the quarter ended June 30, 2016 of $22.1 million, or $0.75 per share, basic and diluted. Net cash used during the quarter ended June 30, 2017 was $21.7 million. Total operating expenses for the quarter ended June 30, 2017 were $36.2 million, compared to $22.3 million for the quarter ended June 30, 2016. Research and development (R&D) expenses for the quarter ended June 30, 2017 were $28.6 million, compared to $16.4 million for the quarter ended June 30, 2016. The increase in R&D expenses was primarily due to an increase in clinical and manufacturing costs to support our ongoing global VELOCITY pediatric trial and our Phase 2/3 trial of somavaratan in pediatric patients in Japan. General and administrative (G&A) expenses for the quarter ended June 30, 2017 were $7.6 million, compared to $5.9 million for the quarter ended June 30, 2016. The increase in G&A expenses was primarily due to additional payroll, consulting, and professional services expenses as we continue to increase our headcount and expand our infrastructure to support our growth. Total operating expenses for the quarter ended June 30, 2017 include non-cash stock-based compensation expense of $3.7 million, compared to $3.0 million of non-cash stock-based compensation expense for the quarter ended June 30, 2016. Total operating expenses for the six months ended June 30, 2017 were $65.8 million, compared to $46.4 million for the six months ended June 30, 2016. R&D expenses for the six months ended June 30, 2017 were $50.6 million, compared with $34.6 million for the six months ended June 30, 2016, reflecting the increase in manufacturing and clinical costs to support our ongoing Phase 2 and 3 clinical trials for somavaratan noted above. G&A expenses for the six months ended June 30, 2017 were $15.2 million, compared to $11.8 million for the six months ended June 30, 2016. The increase was attributable to additional payroll, consulting, and professional services expenses as noted above to support our continued growth. Total operating expenses for the six months ended June 30, 2017 include non-cash stock-based compensation expense of $7.5 million, compared to $5.4 million of non-cash stock-based compensation expense for the six months ended June 30, 2016. Cash and cash equivalents were $143.4 million as of June 30, 2017. 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. 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, which is 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.


News Article | August 2, 2017
Site: globenewswire.com

MENLO PARK, Calif., Aug. 02, 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 that Jay Shepard, President and CEO, is scheduled to present at the Canaccord Genuity 37th Annual Growth Conference on Wednesday, August 9, 2017 at the InterContinental Boston. Event: Canaccord Genuity 37th Annual Growth Conference Date: Wednesday, August 9, 2017 Time: 10:30 a.m. ET / 7:30 a.m. PT Location: InterContinental Boston – Boston, MA An audio webcast of the Company's presentation 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. 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. 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. 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 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 and we assume no obligation to update them after the date of this press release.


News Article | June 1, 2017
Site: globenewswire.com

MENLO PARK, Calif., June 01, 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 the appointment of Eric Dobmeier to its Board of Directors. “Eric’s experience with pre-commercial and commercial-stage companies, as well as forming successful collaborations will offer a valuable perspective as we work to bring somavaratan to GHD patients in key markets globally,” said Jay Shepard, Chief Executive Officer of Versartis. “His involvement as an executive officer and board member of numerous biotech companies adds further depth to our active board, and we look forward to his participation in the growth of Versartis.” Mr. Dobmeier currently serves as Chief Operating Officer of Seattle Genetics, which is a role he has held since 2011. Since he began his career at Seattle Genetics in 2002, he has also served as Chief Business Officer, Vice President, Corporate Development and General Counsel. He oversees the company's business development, corporate communications, manufacturing and program/alliance management groups, as well as corporate strategy initiatives. While at the company, he has been responsible for the negotiation and completion of multiple corporate alliances, including the ex-U.S./Canada development and commercialization agreement with Takeda Pharmaceutical Company for ADCETRIS®. He has also been instrumental in securing $1.2 billion in financing for Seattle Genetics’ growth. Previously, Mr. Dobmeier was with the law firms of Venture Law Group and Heller Ehrman LLP where he represented technology companies in connection with public and private financings, mergers and acquisitions and corporate partnering transactions. Mr. Dobmeier serves on the Boards of Directors of Stemline Therapeutics, Inc. and Atara Biotherapeutics, Inc. He holds a J.D. from University of California, Berkeley School of Law and an A.B. in History from Princeton University. 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. 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 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 and we assume no obligation to them after the date of this press release.


News Article | June 1, 2017
Site: globenewswire.com

MENLO PARK, Calif., June 01, 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 the appointment of Eric Dobmeier to its Board of Directors. “Eric’s experience with pre-commercial and commercial-stage companies, as well as forming successful collaborations will offer a valuable perspective as we work to bring somavaratan to GHD patients in key markets globally,” said Jay Shepard, Chief Executive Officer of Versartis. “His involvement as an executive officer and board member of numerous biotech companies adds further depth to our active board, and we look forward to his participation in the growth of Versartis.” Mr. Dobmeier currently serves as Chief Operating Officer of Seattle Genetics, which is a role he has held since 2011. Since he began his career at Seattle Genetics in 2002, he has also served as Chief Business Officer, Vice President, Corporate Development and General Counsel. He oversees the company's business development, corporate communications, manufacturing and program/alliance management groups, as well as corporate strategy initiatives. While at the company, he has been responsible for the negotiation and completion of multiple corporate alliances, including the ex-U.S./Canada development and commercialization agreement with Takeda Pharmaceutical Company for ADCETRIS®. He has also been instrumental in securing $1.2 billion in financing for Seattle Genetics’ growth. Previously, Mr. Dobmeier was with the law firms of Venture Law Group and Heller Ehrman LLP where he represented technology companies in connection with public and private financings, mergers and acquisitions and corporate partnering transactions. Mr. Dobmeier serves on the Boards of Directors of Stemline Therapeutics, Inc. and Atara Biotherapeutics, Inc. He holds a J.D. from University of California, Berkeley School of Law and an A.B. in History from Princeton University. 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. 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 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 and we assume no obligation to them after the date of this press release.


News Article | June 1, 2017
Site: globenewswire.com

MENLO PARK, Calif., June 01, 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 the appointment of Eric Dobmeier to its Board of Directors. “Eric’s experience with pre-commercial and commercial-stage companies, as well as forming successful collaborations will offer a valuable perspective as we work to bring somavaratan to GHD patients in key markets globally,” said Jay Shepard, Chief Executive Officer of Versartis. “His involvement as an executive officer and board member of numerous biotech companies adds further depth to our active board, and we look forward to his participation in the growth of Versartis.” Mr. Dobmeier currently serves as Chief Operating Officer of Seattle Genetics, which is a role he has held since 2011. Since he began his career at Seattle Genetics in 2002, he has also served as Chief Business Officer, Vice President, Corporate Development and General Counsel. He oversees the company's business development, corporate communications, manufacturing and program/alliance management groups, as well as corporate strategy initiatives. While at the company, he has been responsible for the negotiation and completion of multiple corporate alliances, including the ex-U.S./Canada development and commercialization agreement with Takeda Pharmaceutical Company for ADCETRIS®. He has also been instrumental in securing $1.2 billion in financing for Seattle Genetics’ growth. Previously, Mr. Dobmeier was with the law firms of Venture Law Group and Heller Ehrman LLP where he represented technology companies in connection with public and private financings, mergers and acquisitions and corporate partnering transactions. Mr. Dobmeier serves on the Boards of Directors of Stemline Therapeutics, Inc. and Atara Biotherapeutics, Inc. He holds a J.D. from University of California, Berkeley School of Law and an A.B. in History from Princeton University. 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. 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 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 and we assume no obligation to them after the date of this press release.


News Article | June 1, 2017
Site: globenewswire.com

MENLO PARK, Calif., June 01, 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 the appointment of Eric Dobmeier to its Board of Directors. “Eric’s experience with pre-commercial and commercial-stage companies, as well as forming successful collaborations will offer a valuable perspective as we work to bring somavaratan to GHD patients in key markets globally,” said Jay Shepard, Chief Executive Officer of Versartis. “His involvement as an executive officer and board member of numerous biotech companies adds further depth to our active board, and we look forward to his participation in the growth of Versartis.” Mr. Dobmeier currently serves as Chief Operating Officer of Seattle Genetics, which is a role he has held since 2011. Since he began his career at Seattle Genetics in 2002, he has also served as Chief Business Officer, Vice President, Corporate Development and General Counsel. He oversees the company's business development, corporate communications, manufacturing and program/alliance management groups, as well as corporate strategy initiatives. While at the company, he has been responsible for the negotiation and completion of multiple corporate alliances, including the ex-U.S./Canada development and commercialization agreement with Takeda Pharmaceutical Company for ADCETRIS®. He has also been instrumental in securing $1.2 billion in financing for Seattle Genetics’ growth. Previously, Mr. Dobmeier was with the law firms of Venture Law Group and Heller Ehrman LLP where he represented technology companies in connection with public and private financings, mergers and acquisitions and corporate partnering transactions. Mr. Dobmeier serves on the Boards of Directors of Stemline Therapeutics, Inc. and Atara Biotherapeutics, Inc. He holds a J.D. from University of California, Berkeley School of Law and an A.B. in History from Princeton University. 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. 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 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 and we assume no obligation to them after the date of this press release.


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.


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.


MENLO PARK, Calif., Sept. 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 that the VELOCITY Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (GHD) did not meet its primary endpoint of non-inferiority. Non-inferiority versus daily growth hormone was not demonstrated in the intent to treat (ITT) population for the primary efficacy variable, height velocity (HV) at 12 months. The 12-month HV for ITT patients receiving somavaratan twice monthly was 9.44 cm, versus 10.70 cm for those receiving Genotropin® 1 daily. Non-inferiority was defined as the lower bound of the two-sided 95% confidence interval of the difference between somavaratan and Genotropin HV greater than or equal to -2.0 cm/year. In the ITT study population the lower bound of this confidence interval was -2.3 cm/year. In the per protocol population (PP), non-inferiority was demonstrated. The 12-month HV for PP patients receiving somavaratan twice monthly was 9.71 cm, versus 10.63 cm for those receiving Genotropin daily. Somavaratan was well tolerated with treatment discontinuation rate lower than for the Genotropin arm. No new emergent safety signals were observed. “We are very surprised and disappointed to learn the outcome of the VELOCITY trial. Somavaratan showed height velocity in the range we had hoped, but it was not sufficient to demonstrate non-inferiority in this trial,” stated Jay Shepard, President and CEO of Versartis, Inc. “We have done an initial analysis of the top-line data and are continuing to thoroughly review the results to gain greater insight into the trial outcome. We plan to provide a corporate update later this year. I would like to thank the investigators, pediatric GHD patients and families that participated in the VELOCITY trial.” 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.


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.

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