OMER Omeros Corporation

14.5
-0.28  -2%
Previous Close 14.78
Open 14.63
52 Week Low 9.25
52 Week High 25.46
Market Cap $903,761,365
Shares 62,328,370
Float 59,748,633
Enterprise Value $1,147,046,365
Volume 890,755
Av. Daily Volume 499,715
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Upcoming Catalysts

Drug Stage Catalyst Date
Narsoplimab
Hematopoietic stem cell-associated TMA (HSCT-TMA)
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
OMIDRIA (phenylephrine & ketorolac)
Cataract surgery
Approved
Approved
Approved June 2, 2014.
OMS906
MASP-3 inhibitor
Phase 1
Phase 1
Phase 1 data released June 9, 2021 - well tolerated with no apparent safety signals.
Narsoplimab (I-SPY COVID-19)
COVID-19
Phase 2
Phase 2
Phase 2 initiation of dosing announced March 23, 2021.
Narsoplimab
IgA nephropathy
Phase 3
Phase 3
Phase 3 trial ongoing.
Narsoplimab
Atypical hemolytic uremic syndrome (aHUS)
Phase 3
Phase 3
Phase 3 trial ongoing.

Latest News

  1. Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

    Conference Call Details

    To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4195376. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and…

    Omeros Corporation (NASDAQ:OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

    Conference Call Details

    To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 4195376. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 4195376.

    To access the live and subsequently archived webcast of the conference call, go to Omeros' website at https://investor.omeros.com/upcoming-events.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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  2. -- Data on Organ Function Improvement Presented by Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering --

    Omeros Corporation (NASDAQ:OMER) today announced that data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 26th Congress of the European Hematology Association (EHA). The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, was delivered last Friday by Miguel-Angel Perales, M.D., Chief of Adult…

    -- Data on Organ Function Improvement Presented by Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering --

    Omeros Corporation (NASDAQ:OMER) today announced that data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 26th Congress of the European Hematology Association (EHA). The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, was delivered last Friday by Miguel-Angel Perales, M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. The organ function improvement data presented underscore the potential of narsoplimab as a significant advance in the treatment of often fatal HSCT-TMA.

    The trial's findings include:

    • The study population was high-risk, with 93 percent having multiple risk factors for poor outcomes, and highly reflective of "real-world" clinical practice
    • At baseline:
      • 75% of patients had kidney dysfunction
      • 57% had neurologic dysfunction
      • 18% had pulmonary dysfunction
      • 50% had multiple organ TMA involvement
      • 86% had significant infection
      • 68% had graft versus host disease (GVHD)
    • 61% of the intent-to-treat (ITT) population (any patient receiving at least 1 dose of narsoplimab) and 74% of the per-protocol (PP) population (those patients receiving ≥ 4 weeks of dosing) responded to narsoplimab based on improvement in laboratory TMA markers (platelet count improvement and reduction in LDH levels) and clinical status (organ function or freedom from transfusion)
    • 74% of eligible patients in the ITT population experienced improvement in organ function (67%, 50% and 100% in kidney, neurologic, or gastrointestinal function, respectively); 77% of eligible patients in the PP population experienced organ function improvement
    • 48% of eligible patients in the ITT population and 55% in the PP population experienced freedom from transfusion
    • Narsoplimab was well tolerated in this very sick population
      • The most common adverse events were pyrexia, diarrhea, vomiting, nausea, neutropenia, fatigue, and hypokalemia, all common in HSCT
      • Six patients died during the core study period due to causes common in HSCT
      • There were no study discontinuations due to non-fatal adverse events

    Detailed data and findings from the study are being submitted to a peer-reviewed scientific journal for publication.

    Dr. Perales' question-and-answer panel discussion for his presentation is scheduled for Tuesday, June 15, at 1:00-1:45 pm CEST/7:00-7:45 am EDT and will be available to registered attendees through the EHA Congress virtual platform.

    In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, significant morbidity is common with chronic organ injury often persisting. There is no approved treatment for HSCT-TMA. A Biologics License Application for use of narsoplimab in the treatment of HSCT-TMA is under Priority Review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act action date of October 17, 2021.

    About Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy

    Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) is a significant and often lethal complication of stem cell transplantation. This condition is a systemic, multifactorial disorder caused by endothelial cell damage induced by conditioning regimens, immunosuppressant therapies, infection, graft-versus-host disease, and other factors associated with stem cell transplantation. Endothelial damage, which activates the lectin pathway of complement, plays a central role in the development of HSCT-TMA. The condition occurs in both autologous and allogeneic transplants but is more common in the allogeneic population. In the United States and Europe, approximately 25,000 to 30,000 allogeneic transplants are performed annually. Recent reports in both adult and pediatric allogeneic stem cell transplant populations have found an approximately 40-percent incidence of HSCT-TMA, and high-risk features may be present in up to 80 percent of these patients. In severe cases of HSCT-TMA, mortality can exceed 90 percent and, even in those who survive, long-term renal sequalae (e.g., dialysis) are common. There is no approved therapy or standard of care for HSCT-TMA.

    About Narsoplimab

    Narsoplimab, also known as "OMS721," is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target and the effector enzyme of the lectin pathway of complement. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2.

    A biologics license application (BLA) is under priority review by the U.S. FDA for use of narsoplimab in the treatment of HSCT-TMA, and the drug is in Phase 3 clinical programs for immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic syndrome (aHUS). Narsoplimab is also being evaluated for the treatment of COVID-19 as part of the I-SPY-COVID-19 platform trial sponsored by Quantum Leap Healthcare Collaborative. The FDA has granted narsoplimab breakthrough therapy designations for HSCT-TMA and for IgA nephropathy; orphan drug status for the prevention (inhibition) of complement-mediated thrombotic microangiopathies, for the treatment of HSCT-TMA and for the treatment of IgA nephropathy; and fast track designation for the treatment of patients with aHUS. The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in HSCT and for treatment of primary IgA nephropathy.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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  3. -- Inhibitors of PDE7 Enzymes Could Treat Nicotine Abuse --

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced publication of the article "Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission" in the peer-reviewed Journal of Neuroscience.

    The article describes for the first time the effect of selective inhibitors of phosphodiesterase…

    -- Inhibitors of PDE7 Enzymes Could Treat Nicotine Abuse --

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced publication of the article "Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission" in the peer-reviewed Journal of Neuroscience.

    The article describes for the first time the effect of selective inhibitors of phosphodiesterase 7 (PDE7), an enzyme that regulates the intracellular levels of the second messenger cyclic adenosine monophosphate, on nicotine consumption. Specifically, inhibitors of PDE7 reduced nicotine consumption and relapse in rodent models of nicotine abuse. Inhibition of PDE7 by Omeros' proprietary small molecules such as OMS527, which was previously reported to have no safety concerns and a pharmacokinetic profile consistent with once-daily oral dosing in its successful Phase 1 trial, resulted in potentiation of intracellular signaling linked to dopamine D1 receptors, which can restore the dopaminergic transmission altered by nicotine. In the study it was also observed that PDE7 inhibition did not elicit conditioned place preference and did not induce intravenous self-administration, indicating lack of abuse liability of OMS527. The research was conducted in collaboration with the School of Pharmacy of the University of Camerino in Italy.

    "In my 30 years of research in addiction, I have rarely seen such a clear and promising effect as that seen with PDE7 inhibitors," said Roberto Ciccocioppo, Professor of Pharmacology and Head of the School of Advanced Studies at the University of Camerino. "I am also excited about the mechanism of action of these molecules. They act by restoring the dopaminergic transmission, which is altered by chronic nicotine use. Equally important, they have this effect without any signs of abuse potential. Considering the general role of dopamine transmission in substance use disorder, I expect that administration of PDE7 inhibitors would also reduce the motivation of other drugs of abuse, such as opioids, psychostimulants and alcohol."

    About Tobacco Use Disorders

    The World Health Organization (WHO) estimates that there are 1.25 billion smokers worldwide, representing one third of the global population over the age of 15. As many as 5 million deaths occur each year as a result of tobacco use. In industrialized countries, approximately 90% of lung cancer, 80% of chronic respiratory disease, and about 20% of cardiovascular diseases are attributed to tobacco use. Recent developments such as forms of electronic nicotine delivery are contributing to a new surge of nicotine use, especially in young adults. Development of novel and more efficacious treatment for smoking cessation can have an important impact on public health. Omeros owns global rights to the use of PDE7 inhibitors for the treatment of addictive disorders.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "look forward to," "may," "objective," "plan," "potential," "predict," "project," "should," "slate," "target," "will," "would" and similar expressions and variations thereof. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with unproven preclinical and clinical development activities, regulatory processes and oversight, challenges associated with manufacture or supply of our investigational products, intellectual property claims, competitive developments, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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  4. Omeros Corporation (NASDAQ:OMER), today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the BofA 2021 Napa BioPharma Virtual Conference next week. The fireside chat with Bank of America analyst, Geoff Meacham, PhD, is scheduled for Tuesday, June 15, 2021 at 4:30 p.m. EDT.

    The presentation will be webcast. The live and archived webcasts can be accessed at https://investor.omeros.com/upcoming-events. The archived webcast will be available for 30 days.

    About Omeros Corporation
    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic…

    Omeros Corporation (NASDAQ:OMER), today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the BofA 2021 Napa BioPharma Virtual Conference next week. The fireside chat with Bank of America analyst, Geoff Meacham, PhD, is scheduled for Tuesday, June 15, 2021 at 4:30 p.m. EDT.

    The presentation will be webcast. The live and archived webcasts can be accessed at https://investor.omeros.com/upcoming-events. The archived webcast will be available for 30 days.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

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  5. -- Results show good safety and PK/PD profile consistent with low-dose, once-monthly subcutaneous dosing --

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. The ongoing trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV…

    -- Results show good safety and PK/PD profile consistent with low-dose, once-monthly subcutaneous dosing --

    Omeros Corporation (NASDAQ:OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. The ongoing trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) administration of OMS906 to healthy adult volunteers. OMS906 has been well tolerated at all doses tested. Preliminary human PK and PD data are consistent with once-monthly SC dosing.

    MASP-3, the key activator of the alternative pathway of complement, converts pro-complement factor D (pro-CFD) to mature CFD. Inhibition of MASP-3 by OMS906 in nonhuman primates reduces systemic levels of mature CFD to below the threshold of detection, correspondingly blocking the alternative pathway of complement. The OMS906 Phase 1 clinical trial design consists of both single- and multiple-ascending dose cohorts. Pharmacodynamic response to OMS906 in the Phase 1 trial is being assessed by quantitation of mature CFD in plasma. In the single-ascending dose stage, 48 subjects have been evaluated to date across a series of IV and SC doses. Findings include:

    • OMS906, administered up to 5 mg/kg, has been well tolerated at all IV and SC doses tested with no apparent safety signals
    • Single 3 mg/kg IV dose of OMS906 suppresses mature CFD below minimum detectable levels for 4 weeks
    • Single lowest SC dose of OMS906 suppresses mature CFD at or below minimum detectable levels for 4 weeks
    • Dose-dependent PK/PD profile across all cohorts is favorable and supports low-dose, once-monthly or less frequent subcutaneous dosing

    The study is ongoing with additional single- and multiple-dose cohorts to determine the pharmacologic dose range and optimal frequency for subcutaneous administration.

    "The data from the Phase 1 clinical trial to date confirm our expectations for the role and dosing of OMS906 in humans," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "The data validate, in humans, the function of MASP-3 – the key activator of the alternative pathway – as a regulator of CFD and support the potential of OMS906 as a safe and long-acting therapeutic for the treatment of alternative pathway-related diseases and disorders. Omeros has built a strong intellectual property position around MASP-3 inhibition, and we look forward to completing the current study and advancing to a Phase 2 clinical trial as quickly as possible."

    About Omeros' MASP-3 Inhibitor Program

    The complement system plays a key role in inflammation and becomes activated as a result of tissue damage or microbial infection. Omeros' MASP-3 inhibitor program includes potent molecules selectively inhibiting mannan-binding lectin-associated serine protease-3 (MASP-3), the protein activator of the alternative pathway of complement (APC). APC inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Omeros is developing both antibody and small molecules to block MASP-3. Through its growing intellectual property position, Omeros exclusively controls inhibitors of the protein activator of the alternative pathway (MASP-3) and, with its OMS721 program, inhibitors of the effector enzyme of the lectin pathway (MASP-2), allowing the company to target with unprecedented precision diseases caused by dysregulation of one or both of these pathways.

    About Omeros Corporation

    Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders. Its commercial product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1%/0.3% continues to gain market share in cataract surgery. Omeros' lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application under priority review by FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial, and the company's PDE7 inhibitor program OMS527, targeting addiction and movement disorders, has successfully completed a Phase 1 trial. Omeros' pipeline holds a diverse group of preclinical programs including a proprietary-asset-enabled antibody-generating technology and a proprietary GPCR platform through which it controls 54 GPCR drug targets and their corresponding compounds. One of these novel targets, GPR174, modulates a new cancer immunity axis recently discovered by Omeros, and the company is advancing GPR174-targeting antibodies and small-molecule inhibitors. For more information about Omeros and its programs, visit www.omeros.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "look forward to," "may," "objective," "plan," "potential," "predict," "project," "should," "slate," "target," "will," "would" and similar expressions and variations thereof. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory processes and oversight, challenges associated with manufacture or supply of our investigational products, intellectual property claims, competitive developments, and the risks, uncertainties and other factors described under the heading "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 1, 2021. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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