PDE7

Omeros Corporation Reports Fourth Quarter and Year-End 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
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Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.

Key Points: 
  • Net loss from continuing operations was $39.3 million for the 2023 fourth quarter compared to $51.7 million for the prior quarter.
  • Total operating expenses for the fourth quarter of 2023 were $39.8 million compared to $48.2 million for the third quarter of 2023.
  • Interest expense during the fourth quarter of 2023 was $7.1 million compared to $7.9 million during the prior quarter.
  • During the fourth quarter of 2023, we earned $3.4 million in interest and other income compared to $4.4 million in the third quarter.

Omeros Corporation Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Neurology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, DSM-IV codes, Survival, Tardive dyskinesia, Bangladesh Technical Education Board, Data analysis, Patent, Investment, Patient, Congress, BLA, Inflammation, Emory University, Therapy, Paroxysmal nocturnal hemoglobinuria, European Hematology Association, Research, Emory, Government, Proteinuria, Kidney International, CUD, Glomerulus, Manuscript, L-DOPA, Hematuria, Safety, Omeros, COVID-19, Inflammation Research, Immunoglobulin A, Fibrosis, PIN, Cancer, PNH, National Institute on Drug Abuse, LID, PDE7, Hemolysis, Complement, Clinical trial, Mannan-binding lectin, Sale, Trial of the century, IgA nephropathy, Corporation, NIDA, Society, C5, Pharmaceutical industry, Reinsurance, Music, Security (finance), Vaccine, Video game, Frontiers, Hematology, Immunology, Agency

“Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.

Key Points: 
  • “Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.
  • Total costs and expenses for the second quarter of 2023 were $40.9 million compared to $37.4 million for the second quarter of 2022.
  • Interest expense during the second quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter.
  • During the second quarter of 2023, we earned $4.5 million in interest and other income compared to $0.7 million in the prior year quarter.

Omeros Corporation Awarded $6.69 Million Grant from the National Institute on Drug Abuse for its OMS527 Addiction Program

Retrieved on: 
Monday, April 10, 2023
Health, Clinical Trials, General Health, Research, Pharmaceutical, Science, Rat, Human, Nicotine, Peer review, Brain, Bangladesh Technical Education Board, Trial of the century, Crave, Corporation, CUD, Cocaine, National Institute on Drug Abuse, Patient, Drug, NIDA, Behavior informatics, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PDE7, Food, Safety, Pharmaceutical industry

Omeros Corporation (Nasdaq: OMER) today announced that it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop Omeros’ lead orally administered compound from its proprietary phosphodiesterase 7 (PDE7) program OMS527 for the treatment of cocaine use disorder (CUD).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop Omeros’ lead orally administered compound from its proprietary phosphodiesterase 7 (PDE7) program OMS527 for the treatment of cocaine use disorder (CUD).
  • Following peer review including leaders in the field from academia and industry, grant funding was awarded on April 7, 2023.
  • Omeros discovered the role of PDE7 in addiction and compulsion and elucidated the associated mechanism of action of PDE7 inhibition.
  • Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award number U01DA058541.

Omeros Corporation Reports Fourth Quarter and Year-End 2022 Financial Results

Retrieved on: 
Monday, March 13, 2023
Oncology, Health, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, Society, Paroxysmal nocturnal hemoglobinuria, Systematic review, Ophthalmology, Addiction, Omnibus spending bill, L-DOPA, PNH, LID, Hematopoietic stem cell transplantation, American Society of Hematology, Investment, Immunoglobulin A, Silicon, News, Manuscript, Cancer, Patient, IgA nephropathy, DSM-IV codes, PIN, Consolidated Appropriations Act, 2021, Government, Silicon Valley Bank, Diagnosis, PDE7, Tardive dyskinesia, Survival, FDA, CAA, Type, Omeros, Emory University, COVID-19, Corporation, BLA, Pharmaceutical industry, Video game, Cryptocurrency, Music, Nursing, Vaccine, Medical imaging, Online shopping, Hematology, Transplant

Net loss from continuing operations for the fourth quarter of 2022 was $46.0 million, or $0.73 cents per share.

Key Points: 
  • Net loss from continuing operations for the fourth quarter of 2022 was $46.0 million, or $0.73 cents per share.
  • During the fourth quarter of 2022, we earned royalties of $17.9 million on $35.8 million of Rayner sales of OMIDRIA.
  • Total costs and expenses for the fourth quarter of 2022 were $40.1 million compared to $50.8 million for the third quarter of 2022.
  • Interest expense during the fourth quarter of 2022 was $7.9 million, an increase of $3.0 million from the third quarter of 2022.

Omeros Corporation Reports Second Quarter 2022 Financial Results

Retrieved on: 
Tuesday, August 9, 2022
Research, Infectious Diseases, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, U.S. Securities and Exchange Commission, Disclosure, OND, Investment, CRL, Security (finance), Marketing, Patient, Rayner, CMS, Securities Act of 1933, Tardive dyskinesia, Lynch, Securities Exchange Act of 1934, Disease, Drug Quality and Security Act, Risk, Inflammation, Sale, Translational medicine, Proteinuria, Immunoglobulin A, Endpoint security, Corporation, Safety, Paroxysmal nocturnal hemoglobinuria, Publication, BLA, PDE7, IgA nephropathy, Ophthalmology, PNH, Death, Forward-looking statement, Growth, Atypical hemolytic uremic syndrome, Micronutrient deficiency, Cancer, Income, COVID-19, Mission statement, Program, Infection, Â, Time, FDA, Ahus, Government, Human, Pharmaceutical industry, Vaccine, Glomerulopathy, Omeros

Rayners reported net sales of $34.5 million for the second quarter of 2022, all of which were in the U.S., establish a new all-time high for quarterly OMIDRIA sales and represent a $5.7 million increase over net sales of $28.8 million reported by Omeros for the second quarter of last year.

Key Points: 
  • Rayners reported net sales of $34.5 million for the second quarter of 2022, all of which were in the U.S., establish a new all-time high for quarterly OMIDRIA sales and represent a $5.7 million increase over net sales of $28.8 million reported by Omeros for the second quarter of last year.
  • At June 30, 2022, Omeros had $122.6 million of cash, cash equivalents and short-term investments available for operations, which is a reduction of $19.7 million from March 31, 2022.
  • During the second quarter of 2022, Omeros earned royalties of $17.2 million on sales of OMIDRIA, which were recorded as a reduction from the OMIDRIA contract royalty asset.
  • Total costs and expenses for the second quarter of 2022 were $37.4 million compared to $45.6 million for the second quarter of 2021.

Omeros’ Narsoplimab Stabilized Kidney Function and Reduced Urinary Complement Proteins in a Patient with IgA Vasculitis

Retrieved on: 
Friday, November 5, 2021
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The objective was to stabilize her rapidly deteriorating kidney function to allow for renal transplantation.

Key Points: 
  • The objective was to stabilize her rapidly deteriorating kidney function to allow for renal transplantation.
  • Diagnosed with IgA vasculitis, she developed rapidly worsening kidney function with highly elevated creatinine levels, hypertension, proteinuria, and hematuria despite treatment with systemic corticosteroids.
  • After one course of 12 weekly doses of narsoplimab, her kidney function stabilized and she was able to undergo successful renal transplantation without the need for dialysis.
  • As reported in yesterdays ASN Annual Meeting presentation, complement levels assessed in urinary samples collected during the patients clinical course demonstrated substantial reduction in local complement activation associated with narsoplimab treatment-related lectin-pathway inhibition and stabilization of kidney function.

Omeros Corporation to Announce Third Quarter Financial Results on November 9, 2021

Retrieved on: 
Thursday, November 4, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Cancer, Corporation, GPCR, IgA nephropathy, NASDAQ, FDA, Phenylephrine, Immunoglobulin A, Omeros, GPR174, Movement disorders, PDE7, COVID-19, Inflammation, Atypical hemolytic uremic syndrome, Neurological disorder, Program, Pharmaceutical industry

Omeros Corporation (NASDAQ: OMER) today announced that the company will issue its third quarter financial results for the period ended September 30, 2021, on Tuesday, November 9, 2021, after the market closes.

Key Points: 
  • Omeros Corporation (NASDAQ: OMER) today announced that the company will issue its third quarter financial results for the period ended September 30, 2021, on Tuesday, November 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.
  • To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally.
  • To access the live and subsequently archived webcast of the conference call, go to Omeros website at https://investor.omeros.com/upcoming-events .

Omeros Receives Complete Response Letter from FDA for Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

Retrieved on: 
Monday, October 18, 2021
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Omeros Corporation (Nasdaq: OMER) today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
  • In the CRL, FDA expressed difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and asserted that additional information will be needed to support regulatory approval.
  • Omeros remains confident in the efficacy and safety data for narsoplimab in HSCT-TMA.
  • Omeros lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement, and Omeros is seeking FDA approval of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Omeros Provides Regulatory Update on Biologics License Application for Narsoplimab in the Treatment of HSCT-TMA

Retrieved on: 
Friday, October 1, 2021
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Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA.

Key Points: 
  • Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA.
  • The BLA for narsoplimab in HSCT-TMA was accepted for filing inJanuary 2021under FDAs Priority Review program.
  • 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.