Gilead Sciences to Acquire CymaBay Therapeutics, Expanding Liver Portfolio

Gilead Sciences, a biopharmaceutical company, has announced its plans to acquire CymaBay Therapeutics for a total equity value of $4.3 billion. The acquisition aims to bolster Gilead's existing liver portfolio and reinforce its commitment to providing innovative treatments for patients. The deal includes CymaBay's lead investigational product, seladelpar, designed to treat primary biliary cholangitis (PBC), a rare and chronic liver disease.

Seladelpar, an oral peroxisome proliferator-activated receptor delta (PPARδ) agonist, has shown promising results in the Phase 3 RESPONSE trial. The trial demonstrated statistical significance in key endpoints, such as biochemical response, normalization of alkaline phosphatase, and improvement in pruritus for patients with moderate-to-severe itching.

The United States Food and Drug Administration (FDA) has accepted the New Drug Application for seladelpar and has granted it priority review status. The Prescription Drug User Fee Act target action date is set for August 14, 2024. Seladelpar has also received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation in both the U.S. and Europe for the treatment of PBC.

Primary biliary cholangitis predominantly affects women, with approximately 1 in 1,000 women over the age of 40 and around 130,000 people in the U.S. living with the disease. PBC can lead to impaired liver function, decreased quality of life, and an increased risk of liver-related mortality.

Gilead's chairman and CEO, Daniel O'Day, expressed enthusiasm for the acquisition, highlighting the potential of seladelpar in addressing the significant unmet needs of PBC patients. Leveraging Gilead's expertise in liver disease treatment, O'Day believes the company can bring seladelpar to patients quickly.

CymaBay's President and CEO, Sujal Shah, expressed his satisfaction with the agreement, stating that years of dedication at CymaBay have led to the potential for new hope for PBC patients. Shah expressed confidence that Gilead's commitment to liver disease management, combined with its regulatory and commercial expertise, will expedite the availability of seladelpar for those in need.

The deal is subject to regulatory approvals and customary closing conditions, with the transaction expected to be completed in the first quarter of 2024. Financial advisory services for Gilead are being provided by BofA Securities, Inc. and Guggenheim Securities, LLC, while Centerview Partners LLC and Lazard are advising CymaBay.

The acquisition of CymaBay and the addition of seladelpar to Gilead's portfolio are expected to enhance revenue growth for the company. While the transaction is predicted to be approximately neutral to earnings per share in 2025, it is anticipated to be significantly accretive thereafter.

The news of Gilead's acquisition of CymaBay highlights the companies' shared commitment to advancing liver disease treatments and addressing unmet medical needs. Patients with primary biliary cholangitis may soon have access to a potentially transformative therapy, pending FDA approval.