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OMEROS CORP (OMER)

Omeros Corporation is a biopharmaceutical firm with commercialized products, actively engaged in the discovery, development, and market introduction of both small-molecule and protein-based therapies, including treatments for rare diseases. The company's therapeutic endeavors primarily focus on inflammatory conditions, illnesses mediated by the complement system, cancers linked to immune system dysregulation, and disorders characterized by addiction or compulsion. Its robust clinical pipeline features several promising candidates. Narsoplimab (also known as OMS721 or MASP-2), a leading asset, has successfully concluded pivotal trials for hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HSCT-TMA). This drug is also currently undergoing Phase III clinical evaluation for immunoglobulin A nephropathy (IgAN) and atypical hemolytic uremic syndrome (aHUS), in addition to a Phase II trial investigating its potential for treating COVID-19. Further expanding its clinical portfolio, Omeros is developing PPAR? (OMS405) in Phase II for opioid and nicotine dependence. PDE7 (OMS527) is progressing through Phase I studies for addiction, compulsive disorders, and movement disorders. Additionally, MASP-3 (OMS906) is currently in Phase I trials for paroxysmal nocturnal hemoglobinuria (PNH) and other conditions involving the alternative complement pathway. Beyond its clinical efforts, the company maintains a dynamic preclinical program. This includes small-molecule inhibitors targeting MASP-2, which are being explored for applications in aHUS, IgAN, HSCT-TMA, and age-related macular degeneration. Also in development is a next-generation, longer-acting antibody that targets MASP-2, alongside MASP-3 small-molecule inhibitors designed to address PNH and other alternative pathway disorders. Omeros's preclinical research further encompasses GPR174 inhibitors, as well as Chimeric Antigen Receptor (CAR) T-Cell and Adoptive T-Cell Therapies for various oncological indications. The company is also investigating G protein-coupled receptor targets for a broad spectrum of diseases, including immunological, immuno-oncological, metabolic, central nervous system (CNS), cardiovascular, musculoskeletal, and other conditions. Established in 1994, Omeros Corporation is headquartered in Seattle, Washington.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Omeros Corporation logo

Omeros Corporation

NASDAQ:OMERHealthcare
-2.69%$18.44
AH$18.45+0.05%vs close
Mkt Cap$1.33B
Float64.19M
O/S72.39M
Vol
$ Vol
RVOL
Inst Own49.9%
SI17.8%
Earnings
Dilution
Omeros Corporation logoNASDAQ:OMER$18.44-2.69%
Phase Distribution
25 lead-sponsored trials·3 active·16 completed
Phase 12
Phase 1/22
Phase 29
Phase 2/31
Phase 310
Not applicable1
(4 more as collaborator)
Status Overview
Recruiting2
Active, not recruiting1
Completed16
Stopped5
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction

    OMS103HP, Vehicle

    Knee Injuries

    Enrollment
    321
    Start
    Nov 2004
    Primary Completion
    Sep 2010
    Completion
    Mar 2011
    NCT00226759
  • Phase 3
    Completed

    Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction

    OMS103HP, Vehicle

    Knee Injuries

    Enrollment
    326
    Start
    Jun 2005
    Primary Completion
    Sep 2010
    Completion
    Mar 2011
    NCT00226772
  • Phase 3
    Completed

    Safety of OMS103HP in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

    OMS103HP, Vehicle

    Anterior Cruciate Ligament Reconstruction

    Enrollment
    480
    Start
    Oct 2004
    Primary Completion
    Mar 2010
    Completion
    Mar 2011
    NCT00245271
  • Phase 3
    Completed

    Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

    OMS103HP-S, Vehicle

    Meniscal Tear

    Enrollment
    344
    Start
    Aug 2011
    Primary Completion
    Nov 2012
    Completion
    Dec 2012
    NCT01406561
  • Phase 3
    Completed

    Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

    OMS302, Placebo

    Intraocular Lens Replacement

    Enrollment
    405
    Start
    Sep 2011
    Primary Completion
    Mar 2012
    Completion
    Mar 2012
    NCT01454063
  • Phase 3
    Completed

    Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

    OMS302, Placebo

    Intraocular Lens Replacement

    Enrollment
    416
    Start
    Apr 2012
    Primary Completion
    Nov 2012
    Completion
    Jan 2013
    NCT01579565
  • Phase 3
    Terminated

    Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery

    Part 1 OMS302, Part 2 OMS302

    Intraocular Lens Replacement, Intraoperative Floppy Iris Syndrome

    Enrollment
    18
    Start
    Feb 2014
    Primary Completion
    Aug 2014
    Completion
    Aug 2014
    NCT02093689
  • Phase 3
    Completed

    A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement

    OMS302, Phenylephrine HCl

    Unilateral Cataract Extraction, Congenital Cataract

    Enrollment
    78
    Start
    Jul 2014
    Primary Completion
    Sep 2016
    Completion
    Sep 2016
    NCT02132312
  • Phase 3
    Terminated

    Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome

    OMS721 (narsoplimab)

    Thrombotic Microangiopathies, Atypical Hemolytic Uremic Syndrome

    Enrollment
    6
    Start
    May 2018
    Primary Completion
    Feb 2021
    Completion
    Feb 2021
    NCT03205995
  • Phase 3
    Terminated

    Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

    OMS721

    IgA Nephropathy

    Enrollment
    360
    Start
    Apr 2018
    Primary Completion
    Jan 2024
    Completion
    Jan 2024
    NCT03608033
  • Phase 2/3
    Completed

    Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy

    OMS103HP, Vehicle

    Postoperative Pain

    Enrollment
    200
    Start
    Dec 2007
    Primary Completion
    May 2009
    Completion
    May 2009
    NCT00624845
  • Phase 2
    Completed

    Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

    OMS302 Solution, OMS302 Mydriatic Solution

    Cataract

    Enrollment
    223
    Start
    Jul 2010
    Primary Completion
    Jan 2011
    Completion
    Feb 2011
    NCT01193127
  • Phase 2
    Completed

    Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects

    OMS643762, Placebo

    Schizophrenia

    Enrollment
    40
    Start
    Sep 2013
    Primary Completion
    Apr 2014
    Completion
    Apr 2014
    NCT01952132
  • Phase 2
    Terminated

    Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease

    OMS643762, Placebo

    Huntington's Disease

    Enrollment
    22
    Start
    Jan 2014
    Primary Completion
    Oct 2014
    Completion
    Oct 2014
    NCT02074410
  • Phase 2
    Completed

    Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

    OMS721

    Thrombotic Microangiopathies

    Enrollment
    58
    Start
    Nov 2014
    Primary Completion
    Jan 2020
    Completion
    Aug 2020
    NCT02222545
  • Phase 2
    Terminated

    Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

    OMS721 (narsoplimab)

    IgAN, LN +2

    Enrollment
    31
    Start
    Mar 2016
    Primary Completion
    Aug 2020
    Completion
    Aug 2020
    NCT02682407
  • Phase 2
    Recruiting

    Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA

    Biological: narsoplimab

    Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation

    Enrollment
    18
    Start
    May 2023
    Primary Completion
    Dec 2025est.
    Completion
    Dec 2025est.
    NCT05855083
  • Phase 2
    Completed

    Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab

    OMS906

    Paroxysmal Nocturnal Hemoglobinuria

    Enrollment
    12
    Start
    Mar 2023
    Primary Completion
    Oct 2024
    Completion
    Oct 2024
    NCT05972967
  • Phase 2
    Recruiting

    Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN

    OMS906 study drug

    C3 Glomerulopathy, Idiopathic Immune Complex-Mediated Glomerulonephritis

    Enrollment
    20
    Start
    Mar 2024
    Primary Completion
    Jan 2026est.
    Completion
    Apr 2026est.
    NCT06209736
  • Phase 2
    Active, not recruiting

    Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

    OMS906 study drug

    Paroxysmal Nocturnal Hemoglobinuria

    Enrollment
    25
    Start
    Feb 2024
    Primary Completion
    Dec 2026est.
    Completion
    Apr 2027est.
    NCT06298955
  • Phase 1/2
    Completed

    Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.

    OMS302, OMS302-PE

    Cataract Extraction

    Enrollment
    60
    Start
    May 2008
    Primary Completion
    Feb 2009
    Completion
    Feb 2009
    NCT00721695
  • Phase 1/2
    Completed

    Pharmacokinetic, Safety and Efficacy Study of OMS201 in Subjects Undergoing Retrograde Ureteroscopic Removal of Upper Urinary Tract Stones

    OMS201, Vehicle

    Urinary Calculi, Urinary Stones +3

    Enrollment
    18
    Start
    Mar 2009
    Primary Completion
    Dec 2010
    Completion
    Dec 2010
    NCT00857090
  • Phase 1
    Completed

    Pharmacokinetic and Safety Study of OMS201 in Subjects Undergoing Ureteroscopic Treatment for Removal of Urinary Tract-Located Stones

    OMS201, Vehicle

    Urinary Calculi, Urinary Stones +1

    Enrollment
    11
    Start
    Dec 2007
    Primary Completion
    -
    Completion
    Sep 2008
    NCT00599664
  • Phase 1
    Completed

    Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria

    OMS906

    Paroxysmal Nocturnal Hemoglobinuria

    Enrollment
    15
    Start
    Dec 2022
    Primary Completion
    Nov 2025
    Completion
    Nov 2025
    NCT05889299
  • Expanded access
    Approved for marketing

    Single Patient Expanded Access Treatment Plan For The Investigational Product Narsoplimab

    Narsoplimab

    Hematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT04247906
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