CSL Vifor

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

4BIO Capital Strengthens Advisory Board and Investment Team

Retrieved on: 
Monday, March 11, 2024

LONDON, 11 March 2024 – 4BIO Capital (“4BIO” or “the Group”), an international venture capital firm unlocking the treatments of the future by investing in advanced therapies and other emerging technologies, announces today the appointments of biopharmaceutical industry veteran Abbas Hussain and world-leading vectorology expert Leszek Lisowski, PhD MBA to its Advisory Board.

Key Points: 
  • LONDON, 11 March 2024 – 4BIO Capital (“4BIO” or “the Group”), an international venture capital firm unlocking the treatments of the future by investing in advanced therapies and other emerging technologies, announces today the appointments of biopharmaceutical industry veteran Abbas Hussain and world-leading vectorology expert Leszek Lisowski, PhD MBA to its Advisory Board.
  • Along with the appointment of Abbas and Leszek, 4BIO is also pleased to announce the promotion of Dr Natalie Johnston to Principal.
  • I am honoured to be joining the 4BIO Capital Advisory Board alongside such esteemed members and look forward to working closely with the entire team to support the firm’s portfolio companies and identify the disruptive companies of the future.”
    Leszek Lisowski, newly appointed Advisory Board member added: “I have watched the 4BIO Capital team’s success over the last 8 years with admiration and I am excited to support them as an Advisory Board member.
  • Fostering the development of our team is core to 4BIO’s philosophy, ensuring we have the very best talent to help drive tomorrow’s innovation.

Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 4, 2024

STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A in the third quarter of 2024.
  • Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026.
  • Wholesalers shipped 110,700 vials to dialysis centers during the fourth quarter of 2023 (an increase of 22% vs. the third quarter of 2023), the majority of which were vials reallocated within the Fresenius network of clinics.
  • Revenues: Total revenue was $3.0 million and $3.3 million for the three months ended December 31, 2023 and 2022, respectively.

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Retrieved on: 
Friday, February 23, 2024

SAN DIEGO, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.

Key Points: 
  • The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan.
  • If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.
  • In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.

Travere Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024

Net product sales for the fourth quarter of 2023 were $39.9 million, compared to $25.8 million for the same period in 2022.

Key Points: 
  • Net product sales for the fourth quarter of 2023 were $39.9 million, compared to $25.8 million for the same period in 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $59.7 million, compared to $58.1 million for the same period in 2022.
  • Total other income, net, for the fourth quarter of 2023 was $5.7 million, compared to $1.1 million for the same period in 2022.
  • ET to discuss company updates as well as fourth quarter and full year 2023 financial results.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Travere Therapeutics Provides Corporate Update and 2024 Outlook

Retrieved on: 
Monday, January 8, 2024

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) --  Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects net product sales from continuing operations for the fourth quarter of 2023 to be approximately $40 million. For the fiscal year 2023, the Company expects net product sales from continuing operations to be approximately $128 million. The Company ended 2023 with approximately $567 million in cash, cash equivalents, and marketable securities which is expected to support operations into 2028. The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated milestones for 2024.

Key Points: 
  • For the fiscal year 2023, the Company expects net product sales from continuing operations to be approximately $128 million.
  • The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated milestones for 2024.
  • "Our strong fourth quarter results reflect the growing demand for FILSPARI in IgAN driven by our field teams’ education and outreach efforts to healthcare providers,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics.
  • The Company expects to announce complete full year 2023 financial results and provide a corporate update in February.

XORTX Welcomes New Member to the Board of Directors

Retrieved on: 
Tuesday, January 2, 2024

CALGARY, Alberta, Jan. 02, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, welcomes Mr. Patrick Treanor to the Board of Directors and announces the resignation of Ian Klassen, both effective December 31, 2023.

Key Points: 
  • CALGARY, Alberta, Jan. 02, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, welcomes Mr. Patrick Treanor to the Board of Directors and announces the resignation of Ian Klassen, both effective December 31, 2023.
  • He previously served as President, US for Vifor Pharma, an international pharmaceutical company focused on nephrology.
  • Mr. Treanor currently serves on the board of directors of KalVista Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors.
  • Anthony Giovinazzo, Chair of XORTX, stated, “We are very pleased to have Patrick Treanor agree to join the XORTX board.

American Kidney Fund Renews Calls for Early Diagnosis and Treatment of Chronic Kidney Disease in New Report

Retrieved on: 
Thursday, November 30, 2023

Advocates urge the U.S. Preventive Services Task Force to make recommendations on screening for chronic kidney disease, and strongly support legislative action for direct Medicare reimbursement to genetic counselors.

Key Points: 
  • Advocates urge the U.S. Preventive Services Task Force to make recommendations on screening for chronic kidney disease, and strongly support legislative action for direct Medicare reimbursement to genetic counselors.
  • Educating health care providers and patients about kidney disease and treatment options: Patient advocates have identified patient education and navigation as major challenges.
  • Many people at high risk aren’t aware of their risk factors and don’t know when to ask for screening for kidney disease.
  • The report also recommends identifying opportunities for advocates and policymakers to weigh in on policies that impact chronic kidney disease care.