Key Developments: Omeros Corp (OMER.OQ)

OMER.OQ on NASDAQ Stock Exchange Global Market

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20 Oct 2014
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Latest Key Developments (Source: Significant Developments)

Omeros receives FDA approval of Omidria for use in cataract and other intraocular lens replacement procedures
Monday, 2 Jun 2014 07:00am EDT 

Omeros Corp:Says U.S. Food and Drug Administration (FDA) has approved Omidria (phenylephrine and ketorolac injection) 1pct/0.3pct for use during cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain.  Full Article

Omeros Corp announces investigational new drug application clearance by FDA for OMS721 in thrombotic microangiopathies
Thursday, 3 Apr 2014 07:00am EDT 

Omeros Corp:Says its Investigational New Drug Application to evaluate OMS721 for the inhibition of complement*mediated thrombotic microangiopathies has been cleared by the U.S. Food and Drug Administration (FDA).  Full Article

Omeros Corp closes $40.25 mln public offering of common stock
Wednesday, 19 Mar 2014 05:20pm EDT 

Omeros Corp:Closes the underwritten public offering of sale of 3,500,000 shares of its common stock at a price of $11.50 per share.Gross proceeds of about $40.25 mln.Intends to use the net proceeds of the offering for general corporate purposes.Cowen and Company, LLC acted as the sole book-running manager for the offering.Wedbush PacGrow Life Sciences acted as co-lead manager.Needham & Company, LLC, Maxim Group LLC, WBB Securities LLC and MLV & Co. LLC acted as co-managers.  Full Article

Omeros Corp prices $35.0 million public offering of common stock
Friday, 14 Mar 2014 08:33am EDT 

Omeros Corp:Has priced an underwritten public offering of 3,043,479 shares of its common stock at a price to the public of $11.50 per share for gross proceeds of $35.0 million.The net proceeds from the sale of the shares, after deducting the underwriters' discounts and other estimated offering expenses, will be about $32.8 million.Omeros has also granted the underwriters a 30-day option to purchase up to an additional 456,521 shares of common stock to cover overallotments, if any, which would result in additional gross proceeds of about $5.2 million if exercised in full.  Full Article

Omeros Corp announces proposed public offering of common stock
Thursday, 13 Mar 2014 04:36pm EDT 

Omeros Corp:Says its intention to offer, subject to market and other conditions, shares of its common stock in a registered underwritten public offering.Expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering solely to cover overallotments, if any.Intends to use the net proceeds of the offering for general corporate purposes.Cowen and Company, LLC is acting as the sole book-running manager for the offering.  Full Article

Omeros Corporation announces positive OMS721 Data in Serum from patients with aHUS
Monday, 10 Mar 2014 07:00am EDT 

Omeros Corporation:Positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program.Thrombotic microangiopathy (TMA) are a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.Phase 2 clinical trial in aHUS and other TMAs expected to begin next quarter.  Full Article

Omeros Corp reports additional positive data from its oms824 phase 2a schizophrenia clinical trial
Thursday, 6 Mar 2014 07:00am EST 

Omeros Corp:Says additional positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor.Patients with schizophrenia were administered a higher dose than had been evaluated in any OMS824 trial, which resulted in about 50 pct higher plasma concentrations than did the previously reported highest dose and had a similar side-effect profile to those of the lower doses.OMS824 inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.The results reported today were in psychiatrically stable patients who continued their usual antipsychotic regimen and received OMS824 or placebo for 14 days.The positive results across all doses tested in this Phase 2a trial indicate that OMS824 can be administered in combination with standard antipsychotic medications.Says that, at tolerated doses, yields plasma concentrations that are predicted to achieve a high degree of PDE10 target interaction in the striatum.  Full Article

Omeros Corp submits IND to advance OMS721 phase two clinical program
Tuesday, 4 Mar 2014 07:00am EST 

Omeros Corp:Says it has submitted to the USFDA an investigational new drug (IND) application to initiate the Phase two clinical program for OMS721.OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin*associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.Last month Omeros announced positive data following completion of dosing in the Phase one clinical trial of OMS721, which was conducted in the Netherlands under a Clinical Trial Application.The initial Phase two clinical trial is an open-label, two-stage ascending-dose-escalation trial in adult subjects with TMA.The objectives of the trial are to evaluate efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of OMS721 in patients with TMAs, including aHUS, TTP and transplant-related TMA.  Full Article

Omeros Corp reports additional positive phase 1 clinical data for Oms824 for the treatment of cognitive disorders
Tuesday, 11 Feb 2014 07:00am EST 

Omeros Corp:Says additional positive data from its Phase 1 program for OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program.This clinical trial evaluated the extent to which OMS824 binds to PDE10, an enzyme expressed in the region of the brain that has been linked to a wide range of diseases that affect cognition.Says the latest cohort enrolled in this trial, OMS824 achieved a high of about 70 percent engagement at PDE10 without evidence of extrapyramidal symptoms (EPS).Says it is completing a Phase 2a trial evaluating the drug in patients with schizophrenia and will start enrollment in a Phase 2 trial for Huntington's disease this quarter.  Full Article

Omeros Corp announces positive data after completion of dosing in phase 1 clinical trial with OMS721
Monday, 3 Feb 2014 07:00am EST 

Omeros Corp:Says positive data following completion of dosing in a phase one clinical trial of OMS721.Says OMS721, administered either by subcutaneous injection or intravenous infusion, was well tolerated and achieved the objective of a high degree of sustained lectin pathway inhibition.Says it expects to initiate a phase two clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome, that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, later this quarter.Says the positive results in the phase one trial enable selection of the dose levels to be evaluated in the phase two program, which will assess the safety and efficacy of OMS721 in patients with disorders thought to involve lectin pathway activation, including TMAs.  Full Article

Omeros suspends mid-stage trial of Huntington's drug, shares fall

- Omeros Corp said it suspended enrolment in a mid-stage study testing its experimental Huntington's drug as the company evaluates data from a concurrent trial in rats, sending its shares down 10 percent before the bell.

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