Jay Traver

Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, November 3, 2023

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced additional data from two pivotal clinical studies demonstrating sparsentan has the potential to preserve kidney function and significantly delay time to kidney failure compared to an active comparator, suggesting long-term benefits in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS). Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT) and The New England Journal of Medicine (DUPLEX).

Key Points: 
  • Data from the Phase 3 PROTECT and DUPLEX Studies were presented as late-breaking oral presentations at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet (PROTECT ) and The New England Journal of Medicine (DUPLEX) .
  • The absolute overall change in kidney function from baseline to the end of the study for patients treated with FILSPARI was -5.8 mL/min/1.73m2 compared to -9.5 mL/min/1.73m2 with irbesartan.
  • Treatment with FILSPARI demonstrated lower rates of the composite endpoint of 40% decline in eGFR, kidney failure or death compared to irbesartan.
  • Sparsentan showed a consistent and sustained achievement of complete remission of proteinuria in 18.5% of patients on sparsentan vs. 7.5% for irbesartan.

Travere Therapeutics to Present Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Friday, October 13, 2023

SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.

Key Points: 
  • SAN DIEGO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the Company will present 11 abstracts, including two late-breaking oral presentations, at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 2-5, 2023.
  • Presentations will highlight the long-term efficacy and tolerability data of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) from the PROTECT Study, as well as the potential for use of FILSPARI as a first-line treatment in newly diagnosed IgAN patients and in combination with SGLT2 inhibitors.
  • The Company will also present data on the efficacy and tolerability of sparsentan in focal segmental glomerulosclerosis (FSGS) and pediatric proteinuric glomerular diseases, as well as provide insights into patient quality of life and the impact of proteinuria on kidney survival in rare kidney diseases.
  • “The data we and our collaborators are presenting at ASN are a testament to our collective dedication to enhance our scientific understanding of kidney diseases to improve patients’ lives,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.

US Nephrologists Embrace Current IgA Nephropathy Therapies, Yet a Thriving Pipeline Signals Fierce Market Evolution Ahead

Retrieved on: 
Friday, October 13, 2023

Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.

Key Points: 
  • Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.
  • As a result, access has understandably become a more prominent and pressing concern, overshadowing the actual availability of disease-targeted treatment options.
  • The landscape of the IgAN pipeline is in a constant state of evolution, with one of the most recent developments coming from Novartis.
  • Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

Travere Therapeutics to Present Abstracts at the 17th International Symposium on IgA Nephropathy (IIGANN 2023)

Retrieved on: 
Tuesday, September 26, 2023

SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.

Key Points: 
  • SAN DIEGO, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present preliminary findings from the SPARTAN Study evaluating the potential effect of FILSPARI® (sparsentan) as a first-line therapy in patients with newly diagnosed IgA nephropathy (IgAN) in a late-breaking trial session at the 17th International Symposium on IgA Nephropathy (IIGANN2023) in Ryogoku, Tokyo, September 28-30, 2023.
  • The Company will also present preclinical data supporting the nephroprotective mechanism of action of sparsentan, a dual endothelin angiotensin receptor antagonist, and an analysis of the UK National Registry of Rare Renal Diseases (RaDaR) which demonstrated that patients with IgAN traditionally considered ‘low-risk’, with proteinuria less than one gram per day, had high rates of kidney failure.
  • “Patients with IgA nephropathy need both early and effective treatment options capable of significant and sustained reduction of proteinuria to preserve kidney function,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.
  • “We’re pleased to be presenting 24-week data on proteinuria reduction, blood pressure control, and safety from the ongoing SPARTAN Study evaluating the effect of sparsentan as a first-line treatment option in patients with newly diagnosed IgAN.”
    Sparsentan Treatment of Incident Patients With IgA Nephropathy as First-line Therapy: Interim Findings From the SPARTAN Trial

Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan

Retrieved on: 
Thursday, September 21, 2023

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • “Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggests potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.
  • Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

Ligand’s Partner Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control

Retrieved on: 
Thursday, September 21, 2023

This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.

Key Points: 
  • This outcome is incredibly important for IgAN patients, who face the risk of progression to kidney failure in their lifetime.
  • We’re proud of the high bar we’ve set in delivering the only head-to-head study in IgAN, which compares FILSPARI against maximally tolerated dose of irbesartan.
  • Since our accelerated approval, we’ve continued to hear inspiring stories of the impact this medicine is having on people living with IgAN.
  • While eGFR total slope narrowly missed statistical significance, the overall evidence from PROTECT suggest potential long-term benefit of FILSPARI as a foundational treatment for patients with IgAN.

Mirum Pharmaceuticals Completes Acquisition of Bile Acid Product Portfolio for Treatment of Rare Liver Diseases from Travere Therapeutics

Retrieved on: 
Tuesday, September 5, 2023

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the completion of Mirum’s previously announced acquisition of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings (the “Asset Purchase”).

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced the completion of Mirum’s previously announced acquisition of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings (the “Asset Purchase”).
  • In connection with the closing of the Asset Purchase, Travere received an upfront payment of $210 million from Mirum, and remains eligible to receive up to $235 million in potential sales-based milestone payments.
  • The closing of the Asset Purchase was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
  • In connection with the closing, Travere will provide certain transitional services to Mirum.

Travere Therapeutics Completes Sale of Bile Acid Product Portfolio to Mirum Pharmaceuticals

Retrieved on: 
Tuesday, September 5, 2023

SAN DIEGO and FOSTER CITY, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced the completion of the previously announced sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings (the “Asset Purchase”). In connection with the closing of the Asset Purchase, Travere received an upfront payment of $210 million from Mirum, and remains eligible to receive up to $235 million in potential sales-based milestone payments.

Key Points: 
  • SAN DIEGO and FOSTER CITY, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced the completion of the previously announced sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings (the “Asset Purchase”).
  • In connection with the closing of the Asset Purchase, Travere received an upfront payment of $210 million from Mirum, and remains eligible to receive up to $235 million in potential sales-based milestone payments.
  • The closing of the Asset Purchase was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.
  • In connection with the closing, Travere will provide certain transitional services to Mirum.

Mirum Pharmaceuticals Enters Agreement to Acquire Bile Acid Product Portfolio for the Treatment of Rare Liver Diseases from Travere Therapeutics

Retrieved on: 
Monday, July 17, 2023

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.
  • Under the terms of the definitive agreement, Mirum will purchase Travere’s bile acid product portfolio for $445 million, consisting of $210 million upfront and $235 million in potential sales-based milestone payments.
  • Concurrent with entering into the definitive agreement to acquire Travere’s bile acid portfolio, Mirum has also entered into a definitive agreement for the sale of common stock in a private placement.
  • The proceeds from the private placement are intended to fund the up-front payment for the acquisition of Travere’s bile acid portfolio.

Travere Therapeutics Enters Agreement to Sell its Bile Acid Product Portfolio for the Treatment of Rare Liver Diseases to Mirum Pharmaceuticals

Retrieved on: 
Monday, July 17, 2023

SAN DIEGO and FOSTER CITY, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.

Key Points: 
  • Under the terms of the definitive agreement, Mirum will purchase Travere’s bile acid product portfolio for up to $445 million, consisting of $210 million upfront and $235 million in potential sales-based milestone payments.
  • “This agreement is an important step forward in Travere's strategy to deliver our pipeline of innovative medicines to patients living with rare diseases,” said Eric Dube Ph.D., president and chief executive officer of Travere Therapeutics.
  • “This synergistic acquisition of the bile acid portfolio along with the opportunity to sponsor the genetic testing program will help to reinforce our leadership position in pediatric hepatology.
  • For Mirum, Evercore is advising on the acquisition and Gibson, Dunn & Crutcher is acting as legal advisor.