Seladelpar

Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis

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Sabato, Maggio 18, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Hospitals, Clinical Trials, Cholestasis, Itch, Health care, Seladelpar, Patient, Primary biliary cholangitis, University of Miami, Month, Comorbidity, ALT, Ursodeoxycholic acid, Liver disease, GGT, Food, Liver, NDA, European Medicines Agency, University, FDA, Therapy, Safety, Conference, NRS, PBC, ULN, Gilead Sciences, EMA, Child, Cirrhosis, Biomarker, Acquisition, MHRA, Alkaline phosphatase, Data analysis, UDCA, Observation, TB, Liver injury, Gastrointestinal disease, Inflammation, PPAR, Quality of life, ALP, Female, Pharmaceutical industry

Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with primary biliary cholangitis (PBC).

Key Points: 
  • Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with primary biliary cholangitis (PBC).
  • This data will be shared in an oral presentation during the Presidential Plenary of the Digestive Disease Week® 2024 Conference in Washington, DC.
  • Enrolled patients received an open-label oral dose of 10 mg seladelpar once daily, with the majority (97%) also receiving UDCA treatment.
  • Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

CymaBay Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Corporate Update

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Mercoledì, Febbraio 28, 2024
Alkaline phosphatase, Acquisition, Liver, Child, Therapy, EMA, Ursodeoxycholic acid, New Drug Application, Gilead Sciences, Education, IDEAL, FDA, Science, Quality of life, Food, Marketing, U.S. FDA, Breakthrough, ALP, Hospital, PBC, Phase 3, Cirrhosis, Hepatology, Seladelpar, Safety, ULN, European Medicines Agency, Numerical, Patient, MHRA, UDCA, Itch, NDA, NRS, Pharmaceutical industry

NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.

Key Points: 
  • NEWARK, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced corporate updates and financial results for the year and fourth quarter ended December 31, 2023.
  • “2023 was a seminal year for CymaBay with critical achievements in the development of our investigational therapeutic, seladelpar.
  • Net loss for the year ended December 31, 2023 and 2022 was $105.4 million and $106.0 million, or ($0.99) and ($1.21) per share, respectively.
  • Net loss for the three months ended December 31, 2023 was higher than the three months ended December 31, 2022 primarily due to higher operating expenses.

Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

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Lunedì, Febbraio 12, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Hospitals, Clinical Trials, Alkaline phosphatase, EMA, Woman, Gilead Sciences, Multimedia, Liver disease, Quality of life, Ascending cholangitis, PBC, Risk, Hepatology, Cirrhosis, Seladelpar, Therapy, Fatigue, PRIME, Primary biliary cholangitis, Patient, BofA Securities, Guggenheim Partners, Itch, Centerview Partners, Lazard, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.
  • View the full release here: https://www.businesswire.com/news/home/20240211034242/en/
    “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
  • Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, shown to regulate critical metabolic and liver disease pathways.
  • “Today’s agreement with Gilead is the culmination of years of focus and determination at CymaBay to advance seladelpar and bring new hope to people living with PBC and their families,” said Sujal Shah, President, and CEO at CymaBay Therapeutics.

CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar for the Treatment of Primary Biliary Cholangitis

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Lunedì, Febbraio 12, 2024
Alkaline phosphatase, Liver, Child, Ursodeoxycholic acid, New Drug Application, BTD, Cirrhosis, Inflammation, FDA, Quality of life, Food, Breakthrough, Chief, Conditional sentence, PDUFA, ALP, PBC, Seladelpar, Therapy, Fatigue, Patient, Itch, Mortality, NDA, Pharmaceutical industry

NEWARK, Calif., Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid. The FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • PBC is a rare, chronic condition that can lead to inflammation and eventually liver cirrhosis.
  • People living with PBC can also experience symptoms that significantly impact their quality of life such as pruritus (itch) and fatigue.
  • Seladelpar is an investigational, potent, selective, orally active PPARδ agonist, or delpar, in development for PBC treatment.
  • "We are encouraged by the agency's decision to grant priority review for seladelpar, and its recognition of the significant need for new treatment options for people living with PBC.

New Published Data Demonstrates Correlation Between Itch Cytokine Interleukin-31 Reduction and Pruritis Improvement in Primary Biliary Cholangitis in Phase 3 Post-Hoc Analysis of CymaBay's Seladelpar

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Mercoledì, Gennaio 3, 2024
Clinical trial, Liver, Primary biliary cholangitis, Patient, Itch, Conditional sentence, Seladelpar, Hepatology, PBC, Therapy

NEWARK, Calif., Jan. 3, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced the first published findings demonstrating the impact of seladelpar on serum interleukin-31 (IL-31) levels and its correlation with pruritus improvement in people with primary biliary cholangitis (PBC). Seladelpar is a first-in-class oral, selective PPARδ agonist being investigated for the treatment of patients with PBC. The latest findings from a post-hoc analysis of the Phase 3 ENHANCE study, were published today in the open access journal Hepatology and are the first peer-reviewed published report of a correlation in decreases in IL-31, bile acids and pruritus symptoms in PBC following treatment with an investigational agent.

Key Points: 
  • Seladelpar is a first-in-class oral, selective PPARδ agonist being investigated for the treatment of patients with PBC.
  • IL-31 is a cytokine known to mediate pruritus and blocking IL-31 signaling can provide relief in pruritic skin diseases.
  • Baseline IL-31 levels also closely correlated with total (r=0.54, p
  • While current treatments for cholestatic pruritus remain limited, these data can help inform potential novel therapeutic approaches."

CymaBay Therapeutics Hosting Virtual Analyst Day on September 22

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Mercoledì, Settembre 14, 2022
Alkaline phosphatase, Adoption, Primary biliary cholangitis, Inflammation, Therapy, Priority, ALP, Woman, Fibrosis, Twitter, Risk, MD, Disease, FACP, Washington State University, Gene, Liver cancer, Analyst, FACG, LinkedIn, AGAF, Seladelpar, U.S. Securities and Exchange Commission, Patient, Bile, Lipid metabolism, Quality of life, Goal, Annual report, Liver, NASDAQ, European Medicines Agency, Security (finance), GLOBE, PBC, Fatigue, Hepatitis, Pakistan Kidney and Liver Institute, Cholestasis, Food and Drug Administration, Itch, Conditional sentence, Pharmaceutical industry, Medicine

NEWARK, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that management will host a virtual analyst day on seladelpar, the company’s lead asset in development for patients with the autoimmune liver disease, primary biliary cholangitis (PBC) on Thursday, September 22, 2022 at 10:30 am Eastern Time.

Key Points: 
  • CymaBays seladelpar is a potent, selective, orally active delpar or PPAR agonist, in late-stage development for patients with PBC.
  • PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40.
  • The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients.
  • CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

CymaBay Therapeutics Presents Positive PBC Data at the International Liver Congress™ 2022

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Mercoledì, Giugno 22, 2022
Doctor of Philosophy, Fibrosis, Association, Patient Centered Primary Care Collaborative, ALP, Security (finance), PBC, Fatigue, Food and Drug Administration, UDCA, EASL, Primary biliary cholangitis, Inflammation, Annual report, Priority, Lipid metabolism, Itch, Gene, Transplant, SD, University of Toronto, Survival, European Medicines Agency, Conditional sentence, Bile, U.S. Securities and Exchange Commission, Woman, Liver cancer, Congress, Disease, European Association for the Study of the Liver, University, NASDAQ, Quality of life, Associate, Death, Twitter, Liver disease, Patient, Hepatitis, Alkaline phosphatase, Cholestasis, Seladelpar, University of California, San Diego Performance-Based Skills Assessment, Therapy, NCT, LinkedIn, Risk, Pharmaceutical industry, Medical device, Copper, Medicine, Liver, GLOBE

The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.

Key Points: 
  • The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.
  • These findings demonstrate that seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC.
  • Presentations at The International Liver Congress 2022 include:
    Congress attendees can visit CymaBay throughout the meeting at booth 93.
  • A full list of presentations can be found on The International Liver Congress 2022 website.

CymaBay Therapeutics Announces Presentations During The International Liver Congress™ 2022

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Mercoledì, Giugno 8, 2022
Woman, Conditional sentence, Itch, Congress, Alkaline phosphatase, University, NL, Seladelpar, Fibrosis, Carbon tetrachloride, EASL, European Association for the Study of the Liver, Liver cancer, Farnesoid X receptor, Hepatitis, Fatigue, Thyroid hormone receptor, Doctor of Philosophy, Peroxisome, Associate, Priority, Bile, Annual report, Security (finance), Disease, U.S. Securities and Exchange Commission, Inflammation, Cholestasis, Primary biliary cholangitis, ALP, Gene, CA, Telmisartan, Lipid metabolism, PBC, Therapy, Patient, Thyroid, THR, Risk, University of California, San Diego Performance-Based Skills Assessment, Food and Drug Administration, NASDAQ, European Medicines Agency, Twitter, Association, Erasmus MC, LinkedIn, FXR, Medical device, Pharmaceutical industry, Copper, Biostatistics, GLOBE, Liver

NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd 26th.

Key Points: 
  • NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd 26th.
  • Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, We are excited to have the opportunity to present once again this year at the International Liver Congress.
  • Presentations at The International Liver Congress 2022 include:
    Congress attendees can visit CymaBay throughout the meeting at booth 93.
  • A full list of presentations can be found on The International Liver Congress 2022 website.

CymaBay Therapeutics Announces Presentations at Digestive Disease Week® 2022

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Mercoledì, Maggio 11, 2022
Itch, Gene, University of Toronto, U.S. Securities and Exchange Commission, Division, University, Cirrhosis, Wayne, Twitter, Woman, NASDAQ, Gastrointestinal disease, Fatigue, Liver disease, Food and Drug Administration, Patient Centered Primary Care Collaborative, OCA, Henry Ford, Research, Bile, AASLD, Doctor of Philosophy, Fibrosis, Hepatology, Security (finance), Hepatitis, Associate, Toronto Centre, Cholestasis, Inflammation, DDW, Annual report, Wayne State University, Primary biliary cholangitis, Liver cancer, PBC, Lipid metabolism, ALP, European Medicines Agency, MD, Conditional sentence, Priority, Quality of life, GI, Disease, Liver, Assistant, Henry Ford Health System, Phase II, LinkedIn, Alkaline phosphatase, Risk, Therapy, Pharmaceutical industry, GLOBE, Seladelpar, Medicine, Patient, Safety

This presentation will highlight the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival.

Key Points: 
  • This presentation will highlight the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival.
  • The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.
  • PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40.
  • CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

Can-Fite Receives Notice of Patent Allowance in China for NASH Treatment

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Mercoledì, Giugno 16, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Clinical medicine, Medicine, Hepatitis, Steatohepatitis, Non-alcoholic fatty liver disease, Nash, Adenosine receptor, Metabolic syndrome, Adenosine, Seladelpar

This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fites drug platform technology, to reduce liver fat particularly in patients with non-alcoholic steatohepatitis (NASH).

Key Points: 
  • This patent addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fites drug platform technology, to reduce liver fat particularly in patients with non-alcoholic steatohepatitis (NASH).
  • Namodenoson has been out licensed for the treatment of NASH in China and is part of a deal worth up to $74.5 million in milestone payments plus double-digit royalties.
  • The treatment market for NASH in China is projected to reach $6.4 billion by 2027 driven by increasing rates of obesity, metabolic syndrome, and diabetes.
  • This latest NASH patent adds to those already issued in the U.S., Europe, and South Korea, stated Can-Fite CEO Dr. Pnina Fishman.