RAAS

Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

Retrieved on: 
Wednesday, April 24, 2024
Nephrology, Kidney disease, Kidney, Div, Proteinuria, European Commission, Kidney failure, CHMP, Irbesartan, Immunoglobulin A, European, EGFR, Patient, CSL Vifor, CSL, Committee, Civil service commission, RAAS, Teaching hospital, Head, Therapy, CMA, SAN, Pharmaceutical industry

SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (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). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • “The approval of this innovative treatment is based on data from the only head-to-head phase 3 clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.

CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

Retrieved on: 
Wednesday, April 24, 2024
Nephrology, Kidney disease, PROTECT, Proteinuria, European Commission, Kidney failure, Professor, CHMP, Irbesartan, European, EGFR, Senior, Patient, Kidney, CSL Vifor, CSL, Medicine, Committee, Civil service commission, RAAS, Teaching hospital, Clinical trial, Therapy, CMA, SAN, Pharmaceutical industry

ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.
  • "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.

Travere Therapeutics to Present Abstracts on FILSPARI® (sparsentan) in IgA Nephropathy at World Congress of Nephrology and the American Nephrology Nurses Association

Retrieved on: 
Wednesday, April 3, 2024
ART, IgA nephropathy, Congress, Quality of life (healthcare), Patient, SAN, Kidney failure, Immunoglobulin A, RAAS, FSGS, PROTECT, Focal segmental glomerulosclerosis, Abstract, Kidney disease, Therapy, WCN, Proteinuria, ANNA, Communications satellite

SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.

Key Points: 
  • SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the Company will present nine abstracts in rare kidney disease at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina, on April 13-16, 2024, and the American Nephrology Nurses Association (ANNA) National Symposium in Orlando, Florida, on April 14-17, 2024.
  • At WCN, the Company will present subgroup analyses of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) showing the treatment effect across participants with different levels of baseline proteinuria.
  • At ANNA, the Company will present additional insights from the HONUS trial, including health-related quality of life (HRQoL) data and the humanistic burden experienced by patients with IgAN and focal segmental glomerulosclerosis (FSGS).
  • “The data we are presenting at WCN and ANNA reinforce the wealth of evidence supporting FILSPARI’s profile to become an effective foundational treatment replacing RAAS inhibition, with the potential to reduce the lifetime risk of kidney failure for patients with IgAN,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Grifols S.A. - GRFS

Retrieved on: 
Sunday, March 31, 2024
Research, Gotham City, ADR, Haier, RAAS, LLP, News, Pomerantz

NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).

Key Points: 
  • NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).
  • The investigation concerns whether Grifols and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On this news, Grifol’s ADR price fell $0.46 per ADR, or 6.94%, to close at $6.17 per ADR on March 5, 2024.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Grifols S.A. - GRFS

Retrieved on: 
Saturday, March 23, 2024
Research, Gotham City, ADR, Haier, RAAS, LLP, News, Pomerantz

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).
  • The investigation concerns whether Grifols and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On this news, Grifol’s ADR price fell $0.46 per ADR, or 6.94%, to close at $6.17 per ADR on March 5, 2024.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Grifols S.A. - GRFS

Retrieved on: 
Friday, March 15, 2024
Research, Gotham City, ADR, Haier, RAAS, LLP, News, Pomerantz

NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).

Key Points: 
  • NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).
  • The investigation concerns whether Grifols and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • On this news, Grifol’s ADR price fell $0.46 per ADR, or 6.94%, to close at $6.17 per ADR on March 5, 2024.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

OKX Ventures Announces Strategic Investment in 0G, Accelerating On-Chain AI Evolution

Retrieved on: 
Tuesday, March 26, 2024
Ethereum, DA, RAAS, AI, OKX, Weightlessness, Decentralized finance, Polygon, Data, Web 2.0, Cryptocurrency

The first modular AI chain has revolutionized the launch of decentralized AI apps by providing the fastest DA layer.

Key Points: 
  • The first modular AI chain has revolutionized the launch of decentralized AI apps by providing the fastest DA layer.
  • OKX Ventures invested in 0G due to its unique and efficient approach to DA in the blockchain space.
  • This investment aligns with OKX Ventures' commitment to fostering innovation and advancement within the blockchain technology ecosystem.
  • OKX Ventures Dora Yue said: "As Polygon's original DA provider, 0G is dedicated to providing the most modular and unrestricted infrastructure.

Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy

Retrieved on: 
Friday, February 16, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, Chronic kidney disease, Commercialization, Caregiver, Multimedia, Food, BLA, Medication, IgA nephropathy, Risk, RAAS, OPDC, Life expectancy, Otsuka Pharmaceutical, Patient, Immunoglobulin A, Disease, Breakthrough therapy, Biology, Kidney failure, Pharmaceutical industry

Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).

Key Points: 
  • Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy (IgAN; Berger’s disease).
  • This press release features multimedia.
  • Breakthrough therapy designation allows the agency to prioritize and focus resources on the most promising products for which no satisfactory treatment option exists.
  • “We are encouraged by the FDA’s decision to grant breakthrough therapy status for the sibeprenlimab program,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Grifols S.A. - GRFS

Retrieved on: 
Sunday, February 11, 2024
Pomerantz, Research, Gotham City, RAAS, LLP, Haier, Financial services

NEW YORK, Feb. 11, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).

Key Points: 
  • NEW YORK, Feb. 11, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).
  • The investigation concerns whether Grifols and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Grifols S.A. - GRFS

Retrieved on: 
Friday, February 2, 2024
Pomerantz, Gotham City, RAAS, Research, Haier, Prior, LLP, Financial services

NEW YORK, Feb. 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).

Key Points: 
  • NEW YORK, Feb. 02, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Grifols S.A. (“Grifols” or the “Company”) (NASDAQ: GRFS).
  • The investigation concerns whether Grifols and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.