CYNA Snapped Up For $624 Mln, AMRN On Track, Genmab Gets FDA Nod

(RTTNews) - Amarin Corp. plc (AMRN) has completed randomization of patients in its phase III cardiovascular outcomes study to determine whether Vascepa will reduce cardiovascular risk in statin treated patients that still have elevated or high triglyceride levels.

In the study, dubbed REDUCE-IT, 8,175 individual patients have been randomized, in accordance with the study protocol, on a 1:1 basis between Vascepa and placebo, slightly exceeding the 8,000 patients targeted for the trial.

The first interim efficacy and safety analysis of the trial by an independent Data Monitoring Committee is most likely to occur in September 2016 and a second analysis is expected to occur in mid-2017.

Approved in July 2012, Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

AMRN closed Wednesday's trading at $2.80, up 0.36%.

Shares of Cynapsus Therapeutics Inc. (CYNA) jumped over 112% in extended trading on Wednesday, following news that the company will be acquired by privately-held Sunovion Pharmaceuticals Inc.

Sunovion has agreed to acquire Cynapsus for US$40.50 per share in cash, which is equivalent to a total value of about US$624 million (or approximately CAN$820 million). The transaction is expected to close in the fourth quarter of 2016.

Cynapsus' lead compound is APL-130277, a phase III product candidate in development for OFF episodes associated with Parkinson's disease.

We alerted our premium subscribers to CYNA on August 15, 2016 when it was trading around $17.

CYNA closed Wednesday's trading at $18.36, down 0.49%. In after hours, the stock was up 112.42% to $39.

Genmab A/S' (GMXAY.OB) supplemental Biologics License Application for the use of Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia has been approved by the FDA.

Arzerra won its first FDA approval in October 2009 for Chronic Lymphocytic Leukemia, and this is the drug's fourth CLL indication being approved in the U.S.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Net sales of Arzerra by Novartis and GSK for the full year 2015 were GBP 37.3 million, which resulted in royalty income of DKK 76 million to Genmab.

GMXAY.OB closed Wednesday's trading at $79.70, down 2.80%.

Pfizer Inc.'s (PFE) anti-cancer drug XALKORI has received approval in the European Union for yet another indication - this time, for the treatment of adults with ROS1-positive advanced non-small cell lung cancer. The drug was approved by the FDA for the same indication in March of this year.

XALKORI was approved in 2012 in the European Union for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.

In the six months ended July 3, 2016, global sales of XALKORI were $275 million, up 20% over the year-ago period.

PFE closed Wednesday's trading at $34.80, down 0.23%.