Nexvet Reports Financial Results For First Quarter Of Fiscal Year 2017

DUBLIN, Ireland, Nov. 04, 2016 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET) today announced its financial results for the three month period ended September 30, 2016.

Recent highlights include:
  • Advanced preparations for pivotal studies of the anti-NGF mAb therapy frunevetmab for cats and a pivotal safety study of the anti-NGF mAb therapy ranevetmab for dogs
  • Initiated a pivotal target animal safety study of frunevetmab in October
  • Announced publication of two peer-reviewed articles regarding frunevetmab in the Journal of Veterinary Internal Medicine
  • Received cash of $1.62 million in research and development income from the Australian Government in October

"Throughout the quarter, our top priority has been maintaining the development momentum of ranevetmab and frunevetmab, our lead anti-nerve growth factor (NGF) monoclonal antibody (mAb) programs for chronic pain in dogs and cats, respectively. We were pleased to recently initiate a pivotal safety study of frunevetmab. For both lead product candidates, we also recently achieved significant progress across regulatory and Chemistry, Manufacturing and Controls (CMC) activities," commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.

During the quarter, the Company completed analysis of its successful pilot study of frunevetmab and used this analysis to inform the design of a pivotal field efficacy and safety study. Protocol concurrence with the United States Food and Drug Administration's Center for Veterinary Medicine (CVM) has been obtained for this study. The study's clinical sites have been selected, trial material manufacture has been completed, and investigator training began in October. The pivotal target animal safety study, which commenced in late October, will examine the safety of frunevetmab in cats according to standard Veterinary International Conference on Harmonization (VICH) guidance and a protocol previously concurred with CVM.

In support of the Company's frunevetmab CMC technical section submission to CVM, a second 200 liter batch of frunevetmab was produced during the quarter at BioNua, the Company's manufacturing division in Ireland, which is also being prepared for commercial manufacturing of Nexvet's products.

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