In a significant move within the biopharmaceutical industry, Gilead Sciences, Inc. (Nasdaq: GILD) has confirmed its acquisition of CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for a notable $32.50 per share in cash, culminating in a total equity value of $4.3 billion. This strategic acquisition brings CymaBay’s leading investigational product, seladelpar, into Gilead’s portfolio, potentially transforming the treatment landscape for patients with primary biliary cholangitis (PBC), including those suffering from pruritus. This move underscores Gilead’s ongoing commitment to developing innovative treatments for liver diseases.

Seladelpar, a promising investigational drug, functions as a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. Its primary role is to modulate critical pathways associated with metabolic functions and liver diseases. The drug has shown promise in the management of primary biliary cholangitis, a rare, chronic liver condition predominantly affecting women. Characterized by symptoms such as pruritus (itching) and fatigue, primary biliary cholangitis can severely impair liver function and diminish the quality of life.

The United States Food and Drug Administration (FDA) has recognized seladelpar’s potential by completing its filing review, accepting a New Drug Application, and granting it priority review status. This decision sets a target action date of August 14, 2024, highlighting the drug’s potential to meet a significant unmet medical need in the treatment of PBC.

Seladelpar’s efficacy was notably demonstrated in the pivotal Phase 3 RESPONSE trial, where it achieved statistical significance over placebo across primary composite endpoints and showed a significant improvement in pruritus at six months, sustained through 12 months. These results represent a significant advancement in the treatment options available for patients with moderate-to-severe PBC symptoms.

In addition to FDA’s priority review, seladelpar has received Breakthrough Therapy Designation, PRIME status from the European Medicines Agency (EMA), and Orphan Drug Designation in both the U.S. and Europe. These designations underscore the drug’s potential importance in addressing the needs of patients with primary biliary cholangitis.

The acquisition agreement was unanimously approved by the Boards of Directors of both Gilead and CymaBay, with an anticipated closure date within the first quarter of 2024, pending regulatory approvals and customary closing conditions. The tender offer, priced at a 27 percent premium over CymaBay’s closing share price as of February 9, 2024, reflects both the strategic value of the acquisition and confidence in seladelpar’s commercial potential.

Upon FDA approval, seladelpar is expected to significantly enhance Gilead’s revenue growth, with the transaction projected to be neutral to earnings per share in 2025 and substantially accretive thereafter. This acquisition is a testament to Gilead’s strategic focus on expanding its liver disease portfolio and its commitment to addressing unmet medical needs in this area.

Financial advisory roles were fulfilled by BofA Securities, Inc. and Guggenheim Securities, LLC for Gilead Sciences, and Centerview Partners LLC and Lazard for CymaBay, highlighting the significant financial and strategic planning involved in this transaction.

This acquisition marks a pivotal moment in the treatment of liver diseases, especially PBC. Gilead Sciences’ strategic acquisition of CymaBay Therapeutics and its lead product candidate, seladelpar, highlights the importance of innovative therapies in addressing chronic conditions with high unmet needs. The collaboration between Gilead’s extensive experience in liver diseases and CymaBay’s innovative research on seladelpar promises to bring new hope to patients suffering from primary biliary cholangitis. This deal not only signifies a substantial investment in the future of liver disease treatment but also emphasizes the growing importance of targeted therapies in the biopharmaceutical sector.

  CymaBay Therapeutics, Gilead Sciences, Pharma acquisition news, primary biliary cholangitis, seladelpar