Shares of Novavax, Inc. (NASDAQ:NVAX) ended Friday session in green amid volatile trading. The shares closed up +0.11 points or 5.12% at $2.26 with 70.92 million shares getting traded. Post opening the session at $2.25, the shares hit an intraday low of $2.17 and an intraday high of $2.14 and the price vacillated in this range throughout the day. The company has a market cap of $679.23 million and the numbers of outstanding shares have been calculated to be 271.19 million shares.
Novavax, Inc. (NVAX) on September 15, 2016 announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.
Phase 3 Resolve(TM) Trial
The trial was a randomized, observer-blinded, placebo-controlled trial conducted at 60 sites in the United States. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms. The secondary objective of the trial was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD). Finally, the trial also evaluated the safety of the unadjuvanted, 135 microgram dose of the RSV F Vaccine compared to placebo.
“We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results,” said Gregory Glenn M.D., President, Research and Development. “Historically, annual seasonal RSV ARD attack rates between 3% and 7% have been observed in older adults1. In our Phase 2 trial, we observed an RSV ARD attack rate of 4.9% and an RSV msLRTD attack rate of 1.8%. In contrast, we observed an RSV ARD attack rate of 2.0% and an msLRTD attack rate of 0.4% in our Phase 3 trial. These attack rates indicate a mild RSV season in older adults this year. We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults.”
Shares of Endo International plc – Ordinary Shares (NASDAQ:ENDP) ended Friday session in green amid volatile trading. The shares closed up +3.13 points or 15.45% at $23.39 with 21.09Million shares getting traded. Post opening the session at $20.19, the shares hit an intraday low of $20.90 and an intraday high of $23.98 and the price vacillated in this range throughout the day. The company has a market cap of $4.51 Billion and the numbers of outstanding shares have been calculated to be 222.77 million shares.
Endo International plc – Ordinary Shares (ENDP) on Sept. 23, 2016 announced that its Board of Directors has named Paul V. Campanelli President and Chief Executive Officer, effective immediately. Mr. Campanelli currently serves as President of Endo’s Generic and OTC drugs business, Par Pharmaceutical, which accounts for approximately 60 percent of Endo’s total revenues through the first half of 2016. Campanelli, who will also join Endo’s Board of Directors, succeeds Rajiv De Silva , who has stepped down as President, CEO and a member of the Board.
Campanelli, 54, joined Endo in 2015 following Endo’s acquisition of Par Pharmaceutical, where he had served as Chief Executive Officer since 2012. While CEO of Par, Campanelli built a strong leadership team and an industry-leading generics business. Specifically, during his tenure, Par significantly increased total revenue, acquired JHP Pharmaceuticals and established a presence in the European generics market. Since joining Endo, Campanelli has overseen the Company’s U.S. Generic Pharmaceuticals business.
“Given the continued evolution of Endo’s business and Paul’s impressive track record of delivering strong operating results, the Board concluded that Paul is the right leader for Endo at this juncture as we focus on execution and increasing the value of our attractive U.S. Branded, U.S. Generic and International pharmaceutical assets,” stated Roger H. Kimmel , Chairman of the Board of Endo. “Paul has spent a significant portion of his career leading and operating complex generics businesses and overseeing Par’s branded business. The Board believes his experience positions him to drive a broad range of growth initiatives across Endo’s entire portfolio, generating better health outcomes for patients and creating value for Endo’s shareholders.”