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NEWARK, California – CymaBay Therapeutics, Inc. (NASDAQ: NASDAQ:), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for seladelpar, intended for the treatment of primary biliary cholangitis (PBC), a chronic liver disease. The FDA granted priority review of the application and set an expected action date of August 14, 2024.
PBC, which predominantly affects women, can lead to liver cirrhosis and mortality. Symptoms such as itching and fatigue can significantly compromise patients’ quality of life. Seladelpar, a selective agonist of peroxisome proliferator-activated receptor delta (PPARδ), has shown promise in clinical trials, indicating statistically significant improvement in disease markers and symptoms of pruritus.
The NDA submission includes data from more than 500 participants in the seladelpar PBC clinical development program, which features results from the Phase 3 RESPONSE and ENHANCE studies, as well as the long-term ASSURE study and prior Phase 2 studies. The decision of the FDA not convening an advisory committee meeting at this stage suggests confidence in the data provided.
Seladelpar previously received breakthrough therapy designation from the FDA, which facilitated the timely submission of some data and indicates the drug’s potential as a significant improvement over existing therapies. The designation was updated in October 2023, recognizing clinical data that showed reduced alkaline phosphatase (ALP) levels and improved pruritus for patients with PBC.
Klara Dickinson, Chief Regulatory and Compliance Officer at CymaBay, expressed optimism about the FDA’s priority review and seladelpar’s potential to improve the treatment landscape for PBC patients.
CymaBay is focused on developing therapies for liver and other chronic diseases with high unmet medical needs.
This report is based on a press release from CymaBay Therapeutics.
Insights on InvestingPro
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) is at the forefront of innovation with the recent FDA acceptance of seladelpar, and this is reflected in the company’s financial metrics and market performance. According to data from InvestingPro, CymaBay holds a market capitalization of approximately $3.64 billion, demonstrating its substantial presence in the biopharmaceutical sector.
Tips from InvestingPro indicate that CymaBay has seen a significant return over the past week, with a total price return of 7.67% and an even more impressive return over the past year of 206.93%. This suggests strong investor confidence, potentially buoyed by recent FDA news and the company’s promising clinical data for seladelpar.
Despite challenges such as weak gross profit margins, which stand at -54.5% for the trailing twelve months as of Q3 2023, the company maintains a strong liquidity position. This is evident as CymaBay holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. These are critical factors for a biopharmaceutical company that may face significant expenditures on research and development before realizing profits from its products.
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In summary, while CymaBay may not have been profitable in the last twelve months and analysts do not expect profitability this year, the company’s robust performance metrics and strong liquidity position are noteworthy. The FDA’s recent acceptance of seladelpar’s NDA could represent a pivotal moment for CymaBay, potentially improving its market valuation and future revenue streams.
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