Analyst Research

Report Title Price
Provider: Thomson Reuters Stock Report
$25.00
Provider: MacroRisk Analytics/EconomicInvestor
$25.00
Provider: ValuEngine, Inc.
$25.00
Provider: Pechala's Reports
$15.00

NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.

Omeros Corp Announces Clearence Of New Drug Application By FDA For OMS824 In Huntington's Disease


Thursday, 23 May 2013 07:00am EDT 

Omeros Corp announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA. Omeros also announced that it has requested Orphan Drug Designation from the FDA for OMS824 in the treatment of Huntington's disease. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity. This designation is granted to drugs that are expected to provide therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. 

Company Quote

14.61
-0.14 -0.95%
10 Jul 2014