Shares of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) ended Thursday session in red amid volatile trading. The shares closed down -0.43 points or -3.04% at $13.17 with 5.32 million shares getting traded. Post opening the session at $14.03, the shares hit an intraday low of $13.57 and an intraday high of $14.15 and the price vacillated in this range throughout the day. The company has a market cap of $2.68 billion and the numbers of outstanding shares have been calculated to be 138.71 million shares.
Ariad Pharmaceuticals, Inc. (ARIA) on September 28, 2016 announced that its partner Otsuka Pharmaceutical Co., Ltd. (Otsuka) has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig® (ponatinib) for the treatment of chronic myeloid leukemia (CML) resistant or intolerant to preceding drug treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
“Our collaboration with Otsuka has resulted in approval of Iclusig in Japan, providing an important new treatment for patients with refractory CML and Ph+ ALL,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Japan represents a large market opportunity for Iclusig and its first approval in Asia. We are committed to expanding patient access and to continuing our successful partnership with Otsuka as evidenced by recent marketing applications for Iclusig submitted in Korea and Taiwan.”
This approval triggers a $10 million milestone payment to ARIAD from Otsuka under the parties’ collaboration agreement entered in December 2014.
”Treatment failure affects a substantial proportion of CML patients treated with tyrosine kinase inhibitors due to resistance or intolerance. For these patients living with CML in Japan, we are grateful to have Iclusig as a new approved treatment option,” said Arinobu Tojo, M.D., Ph.D, deputy director, Research Hospital, The Institute of Medical Science at the University of Tokyo.
Shares of Novavax, Inc. (NASDAQ:NVAX) ended Thursday session in red amid volatile trading. The shares closed down -0.14 points or -6.36% at $2.06 with 28.28 million shares getting traded. Post opening the session at $2.20, the shares hit an intraday low of $2.00 and an intraday high of $2.25 and the price vacillated in this range throughout the day. The company has a market cap of $539.04 million and the numbers of outstanding shares have been calculated to be 271.19 million shares.
Novavax, Inc. (NVAX) on September 16, 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.