omeros corp (OMER) Key Developments
Omeros Corporation Provides Update on Development of OMS824 Inhibitor for Treatment of Schizophrenia and Huntington's Disease
Oct 21 14
Omeros Corporation provided an update on OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor in development for the treatment of schizophrenia and Huntington's disease. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition. Omeros has suspended its Huntington's clinical trial as it further evaluates an observation from a nonclinical study in rats. The observation occurred in several of the rats receiving the study's maximum dose of OMS824, a dose that resulted in OMS824 free-plasma concentrations multiply higher than those that have been measured in patients. Non-human primates exposed to plasma concentrations equal to those in the rat demonstrated no findings similar to the observation reported from the rat study. OMS824 has been well tolerated in all human clinical trials. Earlier this year, Omeros initiated a Phase 2 trial of OMS824 in patients with Huntington's disease. That trial is a sequential-cohort dose-escalation study that evaluates the safety and tolerability of OMS824 dosed for four weeks in patients with Huntington's disease. Concurrent with the clinical OMS824 program, Omeros is conducting nonclinical studies to allow clinical trials of longer duration. Following preliminary data collection from a 13--week nonclinical study in rats, Omeros submitted a report on an observation in several of the rats receiving the maximum dose administered in the study to FDA's Division of Neurology Products and its Division of Psychiatry Products where Omeros has its Investigational New Drug applications for Huntington's disease and schizophrenia, respectively. The drug exposure at that maximum dose in the rat study is multiply above the drug exposure in humans at the doses used in the Huntington's disease trial, and the potential relevance of the nonclinical findings to humans, if any, is unknown. Based on follow-up communications with FDA, Omeros has suspended the ongoing Huntington's disease trial, the only OMS824 trial actively enrolling. FDA has requested that Omeros further evaluate the nonclinical data from the 13-week rat study as well as nonclinical studies that did not yield the observation in order to characterize it more fully prior to reinitiating the clinical trial. In addition to the 13-week rat study, Omeros has conducted several nonclinical studies with OMS824 in rats and in primates, including a 13--week nonclinical study in primates, at equally high drug exposures to those resulting from the maximal dose in the rat study, with no findings similar to the observation reported from the most recent study in rats. To date, over 120 people have received OMS824 for up to four weeks and the drug is well tolerated. Omeros plans to release available data from the Phase 2 Huntington's program later this year. In addition, other Omeros programs are on track for their near-term milestones.
Omeros Corporation Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014
Sep 10 14
Omeros Corporation Presents at EBD Group's Biopharm America 2014 Conference, Sep-22-2014 . Venue: Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA 02116, United States.
Omeros Corporation Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014
Aug 11 14
Omeros Corporation announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter ended June 30, 2014, Omeros reported a net loss of $18.0 million, or $0.53 per share. This compares to a net loss of $13.6 million or $0.48 per share, for the same period in 2013. Revenue for the quarter ended June 30, 2014 was $45,000 compared to $140,000 for the same period in 2013. This decrease was due to a reduction of activity on NIH grant projects, which resulted in lower revenue being recognized. Loss from operations was $17.217 million against $13.160 million a year ago.
For the six-month period, the company reported revenues were $0.145 million against $1.235 million a year ago. Loss from operations was $32.901 million against $23.180 million a year ago. Net loss was $34.633 million or $1.07 basic and diluted per share against $24.081 million or $0.89 basic and diluted per share a year ago.
Omeros Corporation Presents at Wedbush 2014 Life Sciences Management Access Conference, Aug-12-2014 12:45 PM
Jul 2 14
Omeros Corporation Presents at Wedbush 2014 Life Sciences Management Access Conference, Aug-12-2014 12:45 PM. Venue: Le Parker Meridien, New York, New York, United States. Speakers: Gregory A. Demopulos, Co-Founder, Chairman, Chief Executive Officer and President.
Omeros Corporation Presents at Washington Biotechnology & Biomedical Association 14th Annual Life Science Innovation Northwest 2014, Jun-19-2014 03:00 PM
Jun 11 14
Omeros Corporation Presents at Washington Biotechnology & Biomedical Association 14th Annual Life Science Innovation Northwest 2014, Jun-19-2014 03:00 PM. Venue: Washington State Convention Center, Seattle, Washington, United States.