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FDA sets August 14 review date for CymaBay's PBC drug

EditorIsmeta Mujdragic
Published 02/12/2024, 11:01 AM
© Reuters.
CBAY
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NEWARK, Calif. - CymaBay Therapeutics, Inc. (NASDAQ: NASDAQ:CBAY), a biopharmaceutical company, announced today 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 has granted the application priority review and established a target action date of August 14, 2024.

PBC, which predominantly affects women, can lead to liver cirrhosis and mortality. Symptoms such as pruritus (itching) and fatigue can significantly impair patients' quality of life. Seladelpar, a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, has shown promise in clinical studies, indicating a statistically significant improvement in disease markers and pruritus symptoms.

The NDA submission includes data from over 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 earlier Phase 2 studies. The FDA's decision not to convene an advisory committee meeting at this stage suggests confidence in the data provided.

Seladelpar has previously received Breakthrough Therapy Designation from the FDA, which facilitated the early submission of certain 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 a reduction in alkaline phosphatase (ALP) levels and improvement in pruritus for patients with PBC.

Klara Dickinson, Chief Regulatory and Compliance Officer at CymaBay, expressed optimism about the FDA's priority review and the potential of seladelpar to improve the treatment landscape for PBC patients.

CymaBay focuses on developing therapies for liver and other chronic diseases with high unmet medical need.

This report is based on a press release statement from CymaBay Therapeutics.

InvestingPro Insights

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) stands at the forefront of innovation with its recent FDA acceptance for seladelpar, and this is reflected in the company's financial metrics and market performance. According to InvestingPro data, CymaBay holds a market capitalization of approximately $3.64 billion, showcasing its substantial presence in the biopharmaceutical sector.

InvestingPro Tips indicate that CymaBay has experienced a significant return over the past week, with a 7.67% price total return, and an even more impressive return over the last year at 206.93%. This suggests strong investor confidence, potentially buoyed by the recent FDA news and the company's promising clinical data for seladelpar.

Despite challenges such as weak gross profit margins, which sit at -54.5% for the last 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 R&D expenditures before realizing profits from its products.

For readers interested in a deeper dive into CymaBay's financial health and future prospects, InvestingPro offers additional insights. There are 13 more InvestingPro Tips available that could guide potential investment decisions, which you can explore with the added benefit of a 10% discount on a yearly or biyearly Pro and Pro+ subscription using the coupon code PRONEWS24.

In summary, while CymaBay may not be profitable over the last twelve months and analysts do not anticipate profitability this year, the company's robust return metrics and strong liquidity position are noteworthy. The recent FDA acceptance of seladelpar's NDA could be a pivotal moment for CymaBay, potentially enhancing its market valuation and future revenue streams.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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