IgA nephropathy

Vera Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 9, 2022
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During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

Key Points: 
  • During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.
  • IgAN is a common cause of kidney failure and there is a high unmet medical need for treatment of IgAN globally.
  • We are also pleased to announce initiation of our pivotal Phase 3 COMPASS clinical trial of atacicept in lupus nephritis.
  • Vera reported $114.4 million in cash, cash equivalents, and marketable securities as of September 30, 2022.

Omeros Corporation Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 9, 2022
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Rayners U.S. net sales of OMIDRIA were $33.0 million for the third quarter of 2022.

Key Points: 
  • Rayners U.S. net sales of OMIDRIA were $33.0 million for the third quarter of 2022.
  • In September 2022, results of the narsoplimab treatment arm of the I-SPY COVID-19 adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative were announced.
  • Total costs and expenses for the third quarter of 2022 were $50.8 million compared to $39.8 million for the third quarter of 2021.
  • The increase was primarily due to the manufacturing of narsoplimab drug substance in the third quarter of 2022 for future commercial and clinical use.

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

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Tuesday, November 8, 2022
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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.

KORU Medical Systems Announces Novel Therapy Collaboration for Three Indications with Kira Pharmaceuticals

Retrieved on: 
Tuesday, November 8, 2022
Medical Devices, Health, Clinical Trials, Health Technology, Medical Supplies, Linda, Flo, NASDAQ, IgA nephropathy, Patient, KRMD, CMC, FREEDOM, KORU, Hematology, Nephrology, Partnership, Quality of life, Thrombotic microangiopathy, Therapy, CEO, Pharmaceutical industry

KORU Medical Systems, Inc. (NASDAQ: KRMD) (KORU Medical or the Company), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.

Key Points: 
  • KORU Medical Systems, Inc. (NASDAQ: KRMD) (KORU Medical or the Company), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.
  • Kira will utilize KORU Medicals Freedom System for Phase II studies of Kiras lead program, KP-104, an innovative, first-in-class bifunctional complement inhibitor, in three indications.
  • The expanded Kira partnership reflects the previously announced collaboration with an unnamed partner for a single hematology indication.
  • KORU Medical develops, manufactures, and commercializes innovative and easy-to-use subcutaneous infusion solutions that improve quality of life for patients around the world.

Ionis presents positive Phase 2 data in patients with IgA Nephropathy at American Society of Nephrology's Kidney Week 2022

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Monday, November 7, 2022
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CARLSBAD, Calif., Nov. 7, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN). Results from the study were presented in a poster session at the American Society of Nephrology's (ASN) Kidney Week 2022.

Key Points: 
  • CARLSBAD, Calif., Nov. 7, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN).
  • Resultsfrom the study were presented in a poster session at the American Society of Nephrology's (ASN) Kidney Week 2022.
  • Kidney function, as measured by estimated glomerular filtration rate (eGFR), was maintained in all patients in the study.
  • In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to Ionis Pharmaceuticals and its subsidiaries.

Key Opinion Leader Fireside Chat with Professor Richard Lafayette on the US IgAN Treatment Landscape

Retrieved on: 
Monday, November 7, 2022
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STOCKHOLM, Nov. 7, 2022 /PRNewswire/ --Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Fireside Chat on the IgA Nephropathy (IgAN) treatment landscape in the US on Tuesday, November 8th, 2022 at 1:30pm Eastern Time.

Key Points: 
  • STOCKHOLM, Nov. 7, 2022 /PRNewswire/ --Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Fireside Chat on the IgA Nephropathy (IgAN) treatment landscape in the US on Tuesday, November 8th, 2022 at 1:30pm Eastern Time.
  • The fireside chat will feature a presentation from KOL Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss the importance of proteinuria reduction, the recently published data from Part A of the NefIgArd study, and the existing treatment paradigm in the United States for IgAN patients.
  • Dr. Lafayette is Professor of Medicine (Nephrology) and the Found and Director of the Stanford Glomerular Disease Center and its fellowship training program at Stanford University Medical Center.
  • Dr. Lafayette was a member of the first Kidney News Editorial Board and is a member of the ASN Glomerular Diseases Advisory Group.

Key Opinion Leader Fireside Chat with Professor Richard Lafayette on the US IgAN Treatment Landscape

Retrieved on: 
Monday, November 7, 2022
Associate, KOL, Chandos Chair of Medicine and Anatomy, Primary biliary cholangitis, Stanford University, Nasdaq, New York Medical College, Stada Arzneimittel, Internal medicine, FDA, Royal commission, Senior, CALT, Therapy, European Commission, NOX, CET, Head, Stanford University Medical Center, Found, Long Island, Q&A, Nephrology, Medical Center, Nasdaq Stockholm, American depositary receipt, Proteinuria, Person, Patient, Pharmaceutical industry, IgA nephropathy, Medicine

STOCKHOLM, Nov. 7, 2022 /PRNewswire/ --Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Fireside Chat on the IgA Nephropathy (IgAN) treatment landscape in the US on Tuesday, November 8th, 2022 at 1:30pm Eastern Time.

Key Points: 
  • STOCKHOLM, Nov. 7, 2022 /PRNewswire/ --Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Fireside Chat on the IgA Nephropathy (IgAN) treatment landscape in the US on Tuesday, November 8th, 2022 at 1:30pm Eastern Time.
  • The fireside chat will feature a presentation from KOL Richard Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss the importance of proteinuria reduction, the recently published data from Part A of the NefIgArd study, and the existing treatment paradigm in the United States for IgAN patients.
  • Dr. Lafayette is Professor of Medicine (Nephrology) and the Found and Director of the Stanford Glomerular Disease Center and its fellowship training program at Stanford University Medical Center.
  • Dr. Lafayette was a member of the first Kidney News Editorial Board and is a member of the ASN Glomerular Diseases Advisory Group.

Chinook Therapeutics Presents Updated Data from Atrasentan Phase 2 AFFINITY IgA Nephropathy (IgAN) Patient Cohort, Preclinical Atrasentan Research and Ongoing Clinical Trials at the American Society of Nephrology (ASN) Kidney Week 2022

Retrieved on: 
Thursday, November 3, 2022
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We are encouraged by these results, and look forward to reporting topline proteinuria data from our ongoing phase 3 ALIGN trial in 2023.

Key Points: 
  • We are encouraged by these results, and look forward to reporting topline proteinuria data from our ongoing phase 3 ALIGN trial in 2023.
  • Key highlights from the presentation include the following:
    In the IgAN cohort, median baseline 24-hour urine protein excretion was 1.2 g/day.
  • As of the October 19, 2022 data cutoff, atrasentan was well-tolerated in patients with IgAN, with no treatment-related SAEs.
  • A trial-in-progress overview for the ongoing, global, phase 2, open-label AFFINITY basket study of atrasentan was presented as an informational poster.

Selecta Biosciences Reports Third Quarter 2022 Financial Results and Provides Business Update

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Thursday, November 3, 2022
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Selecta continues to work with its partners to develop a next generation IL-2 molecule to combine with ImmTOR and still anticipates selecting an IL-2 candidate by year-end 2022.

Key Points: 
  • Selecta continues to work with its partners to develop a next generation IL-2 molecule to combine with ImmTOR and still anticipates selecting an IL-2 candidate by year-end 2022.
  • In Q3 2022, Selecta received a $10 million milestone payment from Sobi following the completion of enrollment of DISSOLVE II in June 2022.
  • Selecta management will host a conference call at 8:30 AM ET today to provide a business update and review the companys third quarter 2022 financial results.
  • The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law.

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

Retrieved on: 
Friday, November 4, 2022
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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.