Allogene Therapeutics secured a decisive arbitration ruling on December 15 that granted the company full development and commercial control of its lead investigational product, cema‑cel, in the United States, European Union member states, and the United Kingdom. The decision also cleared the path for Allogene to obtain global commercialization rights from its partner, Servier.
The tribunal’s order removes a key legal uncertainty that had previously limited Allogene’s ability to pursue cema‑cel worldwide. By affirming the company’s rights, the ruling eliminates the risk of a competing claim on the product’s commercial rights and establishes a clear framework for future licensing and partnership negotiations.
With the dispute resolved, Allogene can now focus on its 2026 clinical milestones, particularly the pivotal Phase 2 ALPHA3 trial, which will evaluate cema‑cel as a first‑line consolidation therapy for large B‑cell lymphoma. The interim futility analysis scheduled for the first half of 2026 will be a critical catalyst for the company’s development timeline.
Investors responded positively to the arbitration outcome, reflecting confidence in Allogene’s de‑risked commercialization path and its strengthened position in the allogeneic CAR‑T market. The ruling also supports the company’s broader strategy of expanding its allogeneic platform beyond cema‑cel.
CEO John Smith described the decision as a “decisive win” that “reaffirmed Allogene’s full development and commercial control” and emphasized the company’s commitment to advancing cema‑cel through the clinical pipeline while exploring additional partnership opportunities.
The arbitration decision also addressed the status of the UCART19 V1 product, formerly known as ALLO‑501, which Allogene discontinued in 2021. The tribunal ordered a partial termination of the license for UCART19 V1 and directed Cellectis to negotiate a direct license to Allogene if the company chooses to pursue it. Additionally, the company’s recent discontinuation of ALLO‑647 in the ALPHA3 trial following a fatal adverse event underscores the importance of the cema‑cel platform as the focus of its development efforts.
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