- Arbitration Ruling Reaffirms Allogene’s Full Control of Cemacabtagene Ansegedleucel (Cema-Cel)
- Decision Reconfirms Allogene’s Expanded Sub-License Covering EU and UK Rights with Options for Japan and China, Clearing the Path for Allogene to Acquire Full Global Rights
- 1H 2026 Interim Futility Analysis from the Pivotal Phase 2 ALPHA3 Trial with Cema-Cel in First-Line (1L) Consolidation Large B-Cell Lymphoma (LBCL) Remains on Track
SOUTH SAN FRANCISCO, Calif., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today noted the favorable outcome for Servier in its arbitration with Cellectis (Euronext Growth: ALCLS – NASDAQ: CLLS) as it relates to cemacabtagene ansegedleucel (cema-cel). This decisive win reconfirmed Allogene’s full development and commercial control of cema-cel in the United States, all EU Member States, and the United Kingdom, while clearing the path to obtain full global commercialization rights from Servier.
In particular, the tribunal:
- Rejected Cellectis’s allegations relating to alleged breaches by Servier of its development obligations;
- Rejected Cellectis’s financial claims, finding that milestone payments tied to the pivotal trial are not due until U.S. Food and Drug Administration acceptance of a Biologics License Application (BLA); and
- Ordered only a partial termination of the license strictly limited to the UCART19 V1 product (formerly known as ALLO-501, which was discontinued in 2021 in favor of ALLO-501A/cema-cel) and directed Cellectis to negotiate in good faith a direct license to Allogene on terms substantially similar to the existing agreement, if Allogene elects to pursue it.
With this legal matter resolved, Allogene enters 2026 with improved fundamentals. The company is approaching one of the most meaningful catalyst periods in the allogeneic CAR T field, including a 1H 2026 interim futility analysis comparing MRD conversion with cema-cel following standard fludarabine/cyclophosphamide lymphodepletion versus observation in first line patients with large B-cell lymphoma (LBCL).
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow Allogene Therapeutics on X and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This press release may, in some cases, use terms such as “expect,” “project,” “plan,” “scheduled,” “on track,” “aim,” “will,” “may,” “could,” “guidance,” “estimate,” “can,” and “potential,” and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things: the timing for Allogene’s interim futility analysis from the pivotal phase 2 ALPHA3 trial in cema-cel; whether Allogene is approaching one of the most meaningful catalyst periods in the allogeneic CAR T field; and the potential for Allogene to obtain full global commercialization rights from Servier for cema-cel. Various factors may cause material differences between Allogene’s expectations and actual results, including risks and uncertainties related to: clinical development risks, including our novel allogeneic CAR T approach and the unproven first-line consolidation setting in LBCL, the possibility that early or Phase 1 data may not predict later outcomes, trial delays or enrollment challenges, and adverse events (including those previously observed in certain ALPHA3 arms); contractual and counterparty risks; regulatory risks, including potential FDA or foreign authority disagreement with plans or interpretations, requests for additional data or trials, and possible requirements related to MRD assays; manufacturing and CMC risks, including challenges in consistent, scalable manufacturing and technology implementation that could affect timelines, outcomes, or availability; reliance on third parties, including licensors and collaborators (e.g., Cellectis, Servier, and Foresight Diagnostics); and financial risks relating to continued operating losses, the need for additional financing, and the possibility of not meeting financial guidance. These and other risks are discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including, without limitation, under the “Risk Factors” heading in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 6, 2025. Any forward-looking statements made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom.
Allogene Media/Investor Contact:
Christine Cassiano
EVP, Chief Corporate Affairs & Brand Strategy Officer
Christine.Cassiano@allogene.com
