- Strategic collaboration announced for bispecific programs: Novartis to receive ex-U.S. rights to XmAb®14045 and XmAb®13676, Xencor to retain U.S. commercial rights -

 

- XmAb®18087 and XmAb®20717 named as two XmAb® bispecific oncology candidates for treatment of neuroendocrine tumors and multiple cancers, respectively; on track to have four bispecific programs in clinic in 2017 -

 

MONROVIA, Calif., June 28, 2016  -- Xencor, Inc. (XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today highlighted its lead product candidates and reviewed its recent collaboration with Novartis for the development and commercialization of novel bispecific oncology programs at its Analyst Day in New York City.  In addition, the company announced the expansion of its pipeline with two new bispecific oncology programs.

Toraymyxin(TM) may now be used at hospitals that participated in EUPHRATES trial

 

TORONTO, ONTARIO--(Jun 27, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (EDT.TO)(EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from endotoxemic septic shock, today announced that the U.S. Food and Drug Administration (FDA) has accepted its protocol for Expanded Access of Toraymyxin™, the Company's investigational therapeutic device that removes endotoxin from the bloodstream.

 

The Expanded Access program, sometimes referred to as Compassionate Use, can now begin at certain of the 29 U.S. hospitals that had participated in the recently completed Phase III EUPHRATES clinical trial and have agreed to be part of this program. Patients who meet the clinical criteria for septic shock, are in multiple organ failure and who have elevated levels of endotoxin in the blood, as measured by the Company's FDA cleared Endotoxin Activity Assay (EAA™), would be eligible for the treatment. A similar program is planned for Canada, where there were 12 hospitals engaged in the clinical trial.

 - Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo -

- Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in March 2016 -

- Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST -

 

LONDON, June 27, 2016 -- GW Pharmaceuticals plc (GWPH) (GWP.L) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the first randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added as an adjunct to the patient’s current treatment, achieved the primary endpoint of a significant reduction in the monthly frequency of drop seizures assessed over the entire 14-week treatment period compared with placebo (p=0.0135). This trial follows the announcement in March 2016 of positive results in a pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome. Epidiolex has Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LGS and Dravet syndrome.

DUBLIN and FRAMINGHAM, Mass. - June 27, 2016 - Medtronic plc (MDT), the global leader in medical technology, and HeartWare International, Inc. (HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, today announced that the companies have entered into a definitive merger agreement under which Medtronic will acquire HeartWare in a transaction valued at approximately $1.1 billion. Under the terms of the agreement, Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58.00 per share, in cash. The boards of directors of both Medtronic and HeartWare have unanimously approved the transaction. The acquisition is expected to close during Medtronic`s second fiscal quarter ending Oct. 28, 2016, subject to the satisfaction of customary closing conditions.

 

Medtronic`s acquisition of HeartWare will expand Medtronic`s portfolio of diagnostic tools, therapies and services for patients suffering from heart failure, aligning with Medtronic`s Mission of alleviating pain, restoring health and extending life, and is in line with the Company`s strategy to surround the physician with innovative products while focusing on patients and disease states.