Glomerulopathy

American Kidney Fund Launches Educational Awareness Campaigns for Two Rare Kidney Diseases

Retrieved on: 
Tuesday, September 26, 2023
Infection, Tissue, Kidney failure, AKF, Inflammation, Immunoglobulin A, Kidney, Antibody, Hyperkinesia, C3, New Brunswick neurological syndrome of unknown cause, Novartis, Patient, American Kidney Fund, Blood, Immune system, Glomerulopathy, Diagnosis, Health, Kidney disease, Disease, Pharmaceutical industry, IgA nephropathy

ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).

Key Points: 
  • ROCKVILLE, Md., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) launched educational awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).
  • The campaigns, sponsored by Novartis, provide patients with information about the diseases and connect them with resources to help them better understand and manage these conditions.
  • C3G and IgAN are two types of kidney diseases that are related to improper function of the immune system, which is your body's cells and tissues that fight infection.
  • The C3G and IgAN campaigns are part of AKF’s ongoing work to increase awareness and understanding of rare kidney diseases and ensure people with these conditions have access to critical resources.

American Kidney Fund Announces Support for Two Rare Kidney Disease Education Campaigns

Retrieved on: 
Tuesday, January 24, 2023
Mental health, Disease, Health, Education, IgA nephropathy, Glomerulopathy, AKF, Kidney disease, Kidney, American Kidney Fund, Blood, Caregiver, Autoimmune disease, Patient, Partnership, Kidney failure, Immunoglobulin A, Organization, Inflammation, Pharmaceutical industry, Medicine, Novartis

ROCKVILLE, Md., Jan. 24, 2023 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today announced sponsorship from Novartis Pharmaceuticals Corporation (Novartis) for education and awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).

Key Points: 
  • ROCKVILLE, Md., Jan. 24, 2023 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today announced sponsorship from Novartis Pharmaceuticals Corporation (Novartis) for education and awareness campaigns for two rare kidney diseases: complement 3 glomerulopathy (C3G) and IgA nephropathy (IgAN).
  • Through these campaigns, AKF will provide patient-friendly information to support increased understanding of these complex, rare kidney diseases, including how to manage them, and connect patients to specialized resources and organizations that can further aid them in their care journey.
  • The campaign will also include educational videos, including a series highlighting patient voices, helping those diagnosed with this rare disease feel less alone.
  • For the IgAN campaign, AKF will expand its dedicated IgAN webpage with information about nutrition and mental health resources to help manage the disease.

Omeros Corporation Receives Decision from FDA on Formal Dispute Resolution Request for Narsoplimab

Retrieved on: 
Tuesday, November 8, 2022
Oncology, FDA, Health, Pharmaceutical, Cardiology, Biotechnology, Food, Review, Breakthrough therapy, OND, Corporation, Physician, U.S. Securities and Exchange Commission, Securities Exchange Act of 1934, Atypical hemolytic uremic syndrome, CRL, FDA, Patient, PNH, Survival, Drug Quality and Security Act, Cancer, Forward-looking statement, BLA, IgA nephropathy, COVID-19, Regulation of tobacco by the U.S. Food and Drug Administration, Securities Act of 1933, Division, Immunoglobulin A, Security (finance), Pharmaceutical industry, Agency, Hematology, Omeros, Endocrinology, Glomerulopathy, Cardiology, Nephrology

In its formal dispute resolution request submitted to the Agency in June 2022, Omeros requested OND to direct the review division to accept resubmission of the existing BLA and to commence labeling discussions with the company immediately thereafter.

Key Points: 
  • In its formal dispute resolution request submitted to the Agency in June 2022, Omeros requested OND to direct the review division to accept resubmission of the existing BLA and to commence labeling discussions with the company immediately thereafter.
  • Although that request was denied, the decision proposes a path forward for the resubmission of the BLA based on survival data from the completed pivotal trial versus an historical control group.
  • We look forward to working with the Agency to obtain approval for narsoplimab as soon as possible.
  • The first drug candidate submitted to FDA for approval in TA-TMA, narsoplimab has Breakthrough Therapy and Orphan-Drug designations in this disorder as well as in IgA nephropathy.

Omeros Corporation to Announce Third Quarter Financial Results on November 9, 2022

Retrieved on: 
Friday, November 4, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Corporation, PNH, FDA, BLA, COVID-19, PIN, Immunoglobulin A, Atypical hemolytic uremic syndrome, IgA nephropathy, Cancer, NASDAQ, Omeros, Pharmaceutical industry, Glomerulopathy

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its third quarter financial results for the period ended September 30, 2022, on Wednesday, November 9, 2022, 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, 2022, on Wednesday, November 9, 2022, after the market closes.
  • Omeros management will host a conference call and webcast that same 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, participants must register at the following link to receive a unique PIN: https://register.vevent.com/register/BI4363ad5bbf154eef81c3be16f4e47738 .
  • Omeros long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 clinical trial.

Omeros Corporation Announces Upcoming Presentations at ASH Annual Meeting

Retrieved on: 
Thursday, November 3, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, 2021 Essex County Council election, Corporation, Society, PNH, FDA, BLA, ASH, COVID-19, Immunoglobulin A, Atypical hemolytic uremic syndrome, IgA nephropathy, Cancer, Pharmaceutical industry, Glomerulopathy

Omeros Corporation (Nasdaq: OMER) today announced that two presentations pertaining to Omeros investigational complement inhibitors will be featured at the upcoming 64th American Society of Hematology (ASH) Annual Meeting, which will be held from December 10-13, 2022 in New Orleans.

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that two presentations pertaining to Omeros investigational complement inhibitors will be featured at the upcoming 64th American Society of Hematology (ASH) Annual Meeting, which will be held from December 10-13, 2022 in New Orleans.
  • The following abstracts were published today and are now available on the ASH website at www.hematology.org :
    Session Name: 331.
  • Omeros long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 clinical trial.
  • For more information about Omeros and its programs, visit www.omeros.com
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005648/en/

Omeros Corporation Announces Royalty Monetization Transaction with DRI Healthcare Trust

Retrieved on: 
Monday, October 3, 2022
Biotechnology, Finance, Health, Professional Services, Pharmaceutical, PNH, Securities Exchange Act of 1934, Medicare, Immunoglobulin A, Medicare Part D coverage gap, SEC, Securities Act of 1933, Atypical hemolytic uremic syndrome, FDA, Corporation, Center, COVID-19, Asset purchase agreement, Medicare (United States), U.S. Securities and Exchange Commission, BLA, IgA nephropathy, Sale, DRI, Security (finance), Cancer, Calendar, Forward-looking statement, Centers for Medicare & Medicaid Services, CMS, Holding company, Health insurance, Pharmaceutical industry, Omeros, Glomerulopathy

Omeros Corporation (Nasdaq: OMER) today announced that Omeros has sold to DRI Healthcare Acquisitions LP (DRI), a wholly owned subsidiary of DRI Healthcare Trust, an interest in certain royalty payments based on net sales of OMIDRIA (the Purchased Receivables).

Key Points: 
  • Omeros Corporation (Nasdaq: OMER) today announced that Omeros has sold to DRI Healthcare Acquisitions LP (DRI), a wholly owned subsidiary of DRI Healthcare Trust, an interest in certain royalty payments based on net sales of OMIDRIA (the Purchased Receivables).
  • Omeros received gross proceeds from DRI of $125 million upon closing of the sale of the Purchased Receivables, which was completed pursuant to a Royalty Purchase Agreement between Omeros and DRI, dated September 30, 2022 (the Royalty Purchase Agreement).
  • Based on the payment schedule and associated caps, not until July 2028 will DRI have been paid an aggregate of $125 million, the amount that Omeros has received from DRI.
  • Royalty payments, as received from Rayner, will be allocated between Omeros and DRI each month based on the amount to which DRI is entitled.

Omeros Corporation Receives Interim Response from FDA on Formal Dispute Resolution Request for Narsoplimab

Retrieved on: 
Wednesday, August 17, 2022
FDA, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, FDA, PNH, U.S. Securities and Exchange Commission, Drug Quality and Security Act, OND, Forward-looking statement, Securities Exchange Act of 1934, Breakthrough therapy, Security (finance), Atypical hemolytic uremic syndrome, Immunoglobulin A, Cancer, Calendar, COVID-19, Corporation, Securities Act of 1933, BLA, IgA nephropathy, Pharmaceutical industry, Glomerulopathy, Agency

Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the 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 United States Food and Drug Administration (FDA) provided an interim response to the companys formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
  • Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND).
  • As part of FDAs standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal.
  • Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information.

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 Corporation to Announce Second Quarter Financial Results on August 9, 2022

Retrieved on: 
Thursday, August 4, 2022
General Health, Health, Science, Pharmaceutical, Research, FDA, PNH, Glomerulopathy, Atypical hemolytic uremic syndrome, Immunoglobulin A, Cancer, COVID-19, Corporation, NASDAQ, IgA nephropathy, Pharmaceutical industry, Omeros

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2022, on Tuesday, August 9, 2022, after the market closes.

Key Points: 
  • Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2022, on Tuesday, August 9, 2022, after the market closes.
  • Omeros management will host a conference call and webcast that same 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 (833) 634-2592 from the United States and Canada or (412) 902-4100 internationally and ask to be placed into the Omeros earnings call.
  • For online access to the live or subsequently archived webcast of the conference call, go to Omeros website at https://investor.omeros.com/upcoming-events .

Complement 3 Glomerulopathy Market Insights, Epidemiology and Market Forecasts, 2032 - ResearchAndMarkets.com

Retrieved on: 
Monday, March 28, 2022
Health, Pharmaceutical, Therapy, Diagnosis, United Kingdom, Complement, Glomerulopathy, Comprehension, Technology, Epidemiology, Report, News, Acquisition, Table, Algorithm, Pharmaceutical industry, Medical device, Management, Health insurance

The "Complement 3 Glomerulopathy - Market Insight, Epidemiology and Market Forecast -2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Complement 3 Glomerulopathy - Market Insight, Epidemiology and Market Forecast -2032" report has been added to ResearchAndMarkets.com's offering.
  • The Complement 3 Glomerulopathy market report provides current treatment practices, emerging drugs, Complement 3 Glomerulopathy market share of the individual therapies, current and forecasted Complement 3 Glomerulopathy market Size from 2019 to 2032 segmented by seven major markets.
  • The Complement 3 Glomerulopathy market report gives a thorough understanding of the Complement 3 Glomerulopathy by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis and treatment.
  • The Complement 3 Glomerulopathy epidemiology division provide insights about historical and current Complement 3 Glomerulopathy patient pool and forecasted trend for every seven major countries.