Gilead Sciences shared more data on its $4.3 billion, near-approval liver disease prospect Wednesday, linking the candidate to sustained improvements across two years of treatment.
Gilead’s Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis
Three months after spending $4.3 billion on CymaBay Therapeutics for its primary biliary cholangitis (PBC) med, Gilead Sciences has presented a fresh slice of data as a reminder of seladelpar’s potential while an FDA decision is pending.
Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis
NEWARK, Calif., Feb. 21, 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 New England Journal of Medicine (NEJM) has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an investigational agent, and the only potent, selective peroxisome proliferator-activated receptor delta (PPAR?) agonist or delpar, being studied in adults with primary biliary cholangitis (PBC). Results showed rapid and sustained improvements in reducing cholestasis and liver injury, together with significant reductions in pruritus (itching) across the numerical rating scale (NRS), 5-D Itch Scale, and the PBC-40 questionnaire. Publication of these detailed findings from RESPONSE follows topline data presented as a late breaker at The Liver Meeting® 2023 of the American Association for the Study of Liver Diseases (AASLD) in November 2023.
Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics
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.
Published Data Showes Correlation Between Itch Cytokine Interleukin-31 Reduction and
NEWARK, Calif., Dec. 15, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational treatment, seladelpar, for the management of primary biliary cholangitis, including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid (UDCA). CymaBay has requested a Priority Review of the NDA that, if accepted, would mean the FDA would plan to complete its review within six months of accepting the application.
CymaBay Announces an Oral Presentation of Seladelpar Phase 3 Pivotal Results