Gilead acquires CymaBay Therapeutics for $4.3bn

2024-03-25

突破性疗法并购临床3期临床结果优先审批

Gilead acquires CymaBay Therapeutics for $4.3bn

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来源: Pharmaceutical Technology

The merger positioned Gilead to integrate CymaBay’s investigational lead product candidate, seladelpar, into its portfolio. Credit: Sundry Photography / Shutterstock.com.

Gilead Sciences has concluded the acquisition of CymaBay Therapeutics for $4.3bn.

The strategic move was finalised following the closure of a tender offer for the acquisition of all outstanding shares of CymaBay at $32.50 per share.

CymaBay will now function as a wholly owned Gilead subsidiary.

Last month, Gilead and its subsidiary Pacific Merger Sub signed a definitive merger agreement with CymaBay. The tender offer, which began on 23 February, resulted in Gilead acquiring around 77.3% of CymaBay’s outstanding shares by 22 March.

The shares were promptly accepted for payment following the tender offer’s expiration.

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The merger positioned Gilead to integrate CymaBay’s investigational lead product candidate, seladelpar, into its portfolio.

Seladelpar is being developed to treat primary biliary cholangitis (PBC), including pruritus.

This asset complements Gilead’s current liver portfolio and aligns with its treatment delivery strategy.

The US Food and Drug Administration (FDA) has accepted a new drug application for seladelpar, granting it priority review.

A decision on the regulatory approval under the Prescription Drug User Fee Act is anticipated on 14 August 2024.

Seladelpar was also awarded breakthrough therapy designation by the FDA and received PRIME status [for medicines targeting unmet medical need] from the European Medicines Agency (EMA) for PBC.

In the Phase III RESPONSE trial, a 61.7% biochemical response rate was seen in subjects treated with seladelpar compared to 20% for those on placebo.

25% of seladelpar patients had alkaline phosphatase normalisation at 12 months, with a significant improvement in pruritus at six months sustained through 12 months, compared to 0% for placebo.

Gilead Sciences chairman and CEO Daniel O’Day stated: “The acquisition of CymaBay brings us a potential best in disease therapy that could transform the treatment landscape for people with primary biliary cholangitis.

“I want to thank the CymaBay team for their efforts and commitment to addressing this high unmet need. We look forward to advancing seladelpar and building on Gilead’s more than 20-year legacy of treating and curing liver disease on a global scale.”

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