The FDA has approved Omeros' (OMER) investigational new drug application for the company's OMS721 treatment for complementmediated thrombotic microangiopathies (TMAs), which are rare, debilitating and life-threatening disorders characterized by multiple clots in the body's organs, most commonly the kidney and brain.
The FDA's authorization paves the way for Omeros to start Phase II trials of OMS721, the first one of which is planned for this quarter. (PR)
Omeros (OMER) closes a new credit facility with Oxford Finance and MidCap Financial for $32M. The company will pay interest only through March 2015. Thereafter, principal and interest will due through the March 2018 maturity date.
$19.4M of the loan will pay off Omeros' current debt with Oxford.
The remaining $12.6M will be used for general corporate purposes.
Consensus revenue target for this year is $1.6M, but ramps up to $29M in 2015.
103 mutual funds hold positions, up from 93 a year ago.
Omeros (OMER +3.5%) says more data from Phase I testing of its OMS824 drug support the potential for using the compound as a treatment for schizophrenia, Huntington's Disease and other cognitive disorders.
The testing evaluated the extent to which OMS824 binds to PDE10, an enzyme in the the brain that has been linked to a wide range of diseases that affect cognition. OMS824 achieved a peak of 70% engagement at PDE10.
Omeros now plans to increase the dosage in the trial to see if a higher rate can be achieved.
The company is also completing a Phase IIa trial of OMS824 for schizophrenia and plans to begin enrollment in a Phase II study for Huntington's disease in Q1. (PR)
Omeros (OMER +5.1%) says the FDA granted fast-track status to its OMS824 experimental treatment for cognitive impairment in patients with Huntington's disease, a genetic disorder that affects the brain.
OMER expects to begin enrolling patients this quarter in its Phase 2 trial evaluating OMS824 for Huntington's disease.