FSGS

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.

Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, BTD, Orphan drug, APOL1, RPD, Disease, Patient, Apolipoprotein L1, FSGS, Standard of care, EMA, UPCR, European Medicines Agency, Vertex Pharmaceuticals, Clinical trial, Vertex, Proteinuria, Food, FDA, IDMC, VRTX, Pharmaceutical industry

The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.

Key Points: 
  • The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.
  • In addition, the trial has been expanded to include adolescents with AMKD ages 10 to 17 years.
  • The IDMC also recommended enrolling adolescents with AMKD ages 10 to 17 years in the Phase 3 portion of the study.
  • The European Medicines Agency (EMA) has also granted inaxaplin Priority Medicines (PRIME) and Orphan Drug designations for AMKD.

Ligand Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MRK, Research, CRL, New Drug Application, Investment, Eisai, Growth, Sale, Parent, Novin, Focal segmental glomerulosclerosis, Streptococcus, LGND, FSGS, Breakthrough therapy, BLA, AED, GAAP, Therapy, NASH, Liver, NDA, Depreciation, Breast cancer, Total, Forecasting, Perampanel, Shanda, Telecanthus, ID, Retirement, PDUFA, Vaccine, Symantec Endpoint Protection, Type 2 diabetes, Safety, VRNA, Molluscum contagiosum, F2, Acquisition, Caregiver, Merck, AASLD, FDA, Telephone, Food, Pneumonia, Income tax, Hepatology, COVID-19, Element, Patient, SPA, Pharmaceutical industry

Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.

Key Points: 
  • Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.
  • Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022.
  • Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022.
  • Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter.

Travere Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024
SPARTAN, Research, New Drug Application, Growth, Table, CSL Vifor, DSM-IV codes, Webcast, Conditional, HCU, FY, Medication, Diagnosis, Plasma, Bank statement, Committee, FSGS, UPCR, GAAP, Therapy, CHMP, CMA, International, SAN, Total, Shanda, Kidney disease, Safety, Clinical trial, Quarter, FDA, Food, Risk, Income tax, PMDA, Patient, Disease, Kidney, Pivotal, Proteinuria, Pharmaceutical industry

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.

American Kidney Fund Announces April 30 as the First Annual APOL1-Mediated Kidney Disease (AMKD) Awareness Day

Retrieved on: 
Thursday, January 25, 2024
Vertex Pharmaceuticals, Apolipoprotein L1, Dialysis, Central African, Focal segmental glomerulosclerosis, Kidney failure, Health, Foreign policy, Kidney, FSGS, APOL1, Gene, AKF, Risk, Kidney disease, Genetic testing, Mutation, Disease, Congress, L1, Education, American Kidney Fund, Pharmaceutical industry

ROCKVILLE, Md., Jan. 25, 2024 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) is proud to announce that April 30, 2024 will mark the nation’s first ever AMKD Awareness Day .

Key Points: 
  • ROCKVILLE, Md., Jan. 25, 2024 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) is proud to announce that April 30, 2024 will mark the nation’s first ever AMKD Awareness Day .
  • Building on AKF’s educational campaign for the condition, AMKD Awareness Day aims to spread awareness of APOL1-mediated kidney disease (AMKD) , a spectrum of kidney diseases associated with variants (mutations) in the apolipoprotein L1 (APOL1) gene and linked to an increased risk for rapidly progressing kidney disease in people of Western and Central African descent.
  • People with two mutations are at higher risk of developing genetic forms of kidney disease such as focal segmental glomerulosclerosis (FSGS).
  • Additionally, AKF will provide resources and ways to engage and raise awareness of the important connection between APOL1 gene variants and kidney disease in the months ahead.

Travere Therapeutics Provides Corporate Update and 2024 Outlook

Retrieved on: 
Monday, January 8, 2024
CMA, Risk, Shanda, FDA, Plasma, UPCR, European, FSGS, Disease, Education, Therapy, New Drug Application, Kidney disease, CSL Vifor, Proteinuria, SPARTAN, CHMP, HCU, Growth, Committee, Patient, Safety, Diagnosis, Conditional, Pharmaceutical industry

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.

ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Providing Outlook for 2024

Retrieved on: 
Wednesday, January 3, 2024
Alport syndrome, Quality of life, Entrepreneurship, Inflammasome, NLRP1, Survival, IND, VAR, Letter, Kidney disease, Inflammation, FSGS, AIM2, Health, Human, Therapy, Clinical trial, Diabetic nephropathy, Focal segmental glomerulosclerosis, Kidney, Proteinuria, NLRP3, DKD, ACE, Optimism, SGLT2, Patient, Capital, Fibrosis, Dialysis, Environment, Pharmaceutical industry

Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.

Key Points: 
  • Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.
  • On the financial front, various market watchers are seeing signals that the biotech and pharma investment environment is set to trend positively in 2024.
  • Capital is again starting to flow to companies that are seeking to innovate through differentiated technologies or novel mechanisms of action.
  • We look forward to embarking on what we believe will be a productive 2024.

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
University of Minnesota Medical School, EGFR, Key finding attacks, Heart Protection Study, Kidney failure, Kidney, University Center, SGLT2, Kidney disease, Society, American Society of Nephrology, Quality of life, Disease, Division, Clinical trial, ASN, Jay Traver, Abstract, The New England Journal of Medicine, Overload, University, Immunoglobulin A, Focal segmental glomerulosclerosis, Therapy, Patient, Death, International Pediatric Nephrology Association, SAN, Proteinuria, Pharmaceutical industry, Dietary supplement, Medical device, IgA nephropathy, Irbesartan, PROTECT, Nephrology, FSGS, Lancet

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.

DaVita Unveils New Research to Drive Health Equity and Improve Care Quality during Annual American Society of Nephrology Meeting

Retrieved on: 
Thursday, November 2, 2023
Kidney, Chronic kidney disease, Patient, DaVita Inc., DCR, Physician, Kidney transplantation, Equity, Health, Alport syndrome, Research, Society, American Society of Nephrology, ASN, Health equity, IA Financial Group, Abstract, Kidney disease, Diversity, CKD, Pennsylvania Convention Center, FSGS, IgA nephropathy, Nursing

DENVER and PHILADELPHIA, Nov. 2, 2023 /PRNewswire/ -- DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is presenting the findings of five new research projects at the American Society of Nephrology (ASN)'s annual "Kidney Week," which is currently underway in Philadelphia. The studies are focused on driving health equity and reducing hospitalizations, among other outcomes.

Key Points: 
  • DENVER and PHILADELPHIA, Nov. 2, 2023 /PRNewswire/ -- DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is presenting the findings of five new research projects at the American Society of Nephrology (ASN)'s annual "Kidney Week," which is currently underway in Philadelphia.
  • The studies are focused on driving health equity and reducing hospitalizations, among other outcomes.
  • To learn more about the CKD-RDN please click here , or stop by booth #1004 to meet with DCR representatives.
  • DaVita will share updates throughout the meeting on X (formerly Twitter) on @DaVitaDoc and @DaVitaResearch, and will join the online conversation using #KidneyWk.

ZyVersa Therapeutics Announces a Publication in the Peer-Reviewed Journal, Aging, Linking Inflammasome NLRP3 Activation with Age-Related Structural Changes in the Kidney and Reduced Kidney Function

Retrieved on: 
Wednesday, October 18, 2023
ASC, Hypertrophy, Kidney, Inflammation, Research, Journal, Mouse, Enlargement, Chronic kidney disease, Glomerulosclerosis, Disease, Kidney disease, Focal segmental glomerulosclerosis, Scar, Genetic distance, Podocyte, Therapy, FSGS, Inflammasome, Glomerulus, Super Meat Boy, Pharmaceutical industry, Ageing, NLRP3

Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.

Key Points: 
  • Age-related inflammasome signaling and its effects are compounded in the presence of kidney disease, leading to poorer outcomes.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which can inhibit up to 12 different inflammasomes (including NLRP3 inflammasomes) and their associated ASC specks which perpetuate damaging inflammation.
  • Data demonstrate a critical role for NLRP3 inflammasomes in age-related kidney deterioration, which is exacerbated in the presence of kidney disease.
  • NLRP3 inflammasome signaling and its effects on podocytes may be a critical contributor to a lower threshold for developing kidney disease in older people.