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Allogene Therapeutics Reports Favorable Result for Servier in Arbitration with Cellectis

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Allogene (Nasdaq: ALLO) announced a favorable arbitration ruling that reconfirms its full development and commercial control of cemacabtagene ansegedleucel (cema-cel) in the United States, all EU member states, and the United Kingdom and clears a path to obtain full global commercialization rights from Servier.

The tribunal rejected Cellectis’s claims, found milestone payments tied to the pivotal trial are due only upon FDA acceptance of a BLA, and limited license termination to the UCART19 V1 product (ALLO-501). Allogene expects a meaningful catalyst with a 1H 2026 interim futility analysis from its pivotal Phase 2 ALPHA3 trial of cema-cel in 1L consolidation for large B-cell lymphoma (LBCL).

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Positive

  • Control reconfirmed of cema-cel in US, EU and UK
  • Path to full global rights from Servier cleared
  • Tribunal found pivotal milestone payable only upon FDA BLA acceptance
  • 1H 2026 interim futility analysis on track for ALPHA3 pivotal trial

Negative

  • Partial license termination limited to UCART19 V1 (ALLO-501)
  • Direct license negotiation with Cellectis still required if pursued

News Market Reaction

-2.65%
2 alerts
-2.65% News Effect
-2.5% Trough Tracked
-$9M Valuation Impact
$339M Market Cap
2K Volume

On the day this news was published, ALLO declined 2.65%, reflecting a moderate negative market reaction. Argus tracked a trough of -2.5% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $9M from the company's valuation, bringing the market cap to $339M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Trial phase: Pivotal Phase 2 Interim analysis timing: 1H 2026 Product version terminated: UCART19 V1 discontinued in 2021
3 metrics
Trial phase Pivotal Phase 2 ALPHA3 trial of cema-cel in first-line consolidation LBCL
Interim analysis timing 1H 2026 Interim futility analysis for ALPHA3 MRD conversion
Product version terminated UCART19 V1 discontinued in 2021 Legacy ALLO-501 product ended in favor of ALLO-501A/cema-cel

Market Reality Check

Price: $1.84 Vol: Volume 1,998,410 vs 20-da...
normal vol
$1.84 Last Close
Volume Volume 1,998,410 vs 20-day average 2,426,463, indicating activity slightly below recent norms. normal
Technical Shares at $1.47, trading above 200-day MA of $1.33 but still 61.11% below the 52-week high and 70.51% above the 52-week low.

Peers on Argus

While ALLO was down 2.65% pre-news, several biotech peers also declined, includi...

While ALLO was down 2.65% pre-news, several biotech peers also declined, including CADL (-10.12%), RAPT (-9.82%), and IVVD (-5.53%), suggesting broader sector weakness rather than a company-specific move.

Historical Context

5 past events · Latest: Nov 10 (Neutral)
Pattern 5 events
Date Event Sentiment Move Catalyst
Nov 10 Conference participation Neutral +0.0% Announcement of participation in three upcoming investor conferences.
Nov 06 Earnings and update Positive -5.4% Q3 2025 results with cash of $277.1M and runway into 2H 2027.
Nov 03 Clinical trial update Positive -4.8% ALPHA3 trial-in-progress poster and 1H 2026 futility analysis timing.
Oct 30 Earnings scheduling Neutral -0.8% Scheduling of Q3 2025 earnings call and webcast details.
Aug 27 Conference participation Neutral +0.0% Participation announcement for Citi’s 2025 Biopharma Back to School Summit.
Pattern Detected

Recent history shows negative price reactions to fundamentally positive or neutral updates, especially around clinical progress and earnings, with only conference-participation notices seeing flat reactions.

Recent Company History

Over the last six months, Allogene’s newsflow has centered on financial updates, clinical progress, and conference participation. Q3 2025 results highlighted runway into 2H 2027 and reiterated key milestones like the pivotal Phase 2 ALPHA3 futility analysis in 1H 2026, yet the stock fell on that and on the ALPHA3 ASH poster announcement. Routine conference participation pieces on Aug 27 and Nov 10 saw flat moves, underscoring a pattern where more substantive updates have coincided with selling pressure pre-dating today’s favorable arbitration outcome.

Market Pulse Summary

This announcement clarifies Allogene’s control of cema-cel, reaffirming U.S., EU, and UK rights and ...
Analysis

This announcement clarifies Allogene’s control of cema-cel, reaffirming U.S., EU, and UK rights and outlining a path to full global commercialization from Servier while delaying pivotal-trial milestone payments until BLA acceptance. It also reiterates the pivotal Phase 2 ALPHA3 interim futility analysis planned for 1H 2026 in first-line LBCL. Investors may focus on future ALPHA3 data, ongoing cash burn, and additional regulatory milestones as key drivers for the story.

Key Terms

biologics license application (bla), allogeneic car t, lymphodepletion, mrd, +1 more
5 terms
biologics license application (bla) regulatory
"milestone payments tied to the pivotal trial are not due until U.S. Food and Drug Administration acceptance of a Biologics License Application (BLA);"
A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.
allogeneic car t medical
"a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer"
Allogeneic CAR T is a type of cancer immunotherapy made from immune cells collected from a healthy donor, genetically reprogrammed to recognize and kill cancer cells, and stored like an off‑the‑shelf medicine. For investors it matters because donor-based products can be manufactured at scale and delivered faster and cheaper than patient-specific (custom) therapies, but they also carry different safety and regulatory risks that affect commercial potential and valuation.
lymphodepletion medical
"comparing MRD conversion with cema-cel following standard fludarabine/cyclophosphamide lymphodepletion versus observation"
Lymphodepletion is a short medical treatment that lowers a patient’s lymphocytes, the immune cells that can interfere with certain cell-based therapies, to create a more supportive environment for the new therapy to work. Think of it like clearing a crowded garden bed before planting seeds: by temporarily reducing competing cells, the engineered therapy can take hold more effectively. Investors watch lymphodepletion because it affects clinical trial results, safety profiles, treatment adoption, and overall commercial potential.
mrd medical
"including a 1H 2026 interim futility analysis comparing MRD conversion with cema-cel"
MRD stands for minimal residual disease, the tiny number of cancer cells that can remain in the body after treatment and that may not show up on routine scans. Detecting MRD is like finding a few seeds left in a garden after clearing: it helps doctors predict the chance of relapse and measure how effective a therapy is, which investors watch because MRD results can influence clinical trial success, regulatory decisions, and a drug’s market potential.
large b-cell lymphoma (lbcl) medical
"in First-Line (1L) Consolidation Large B-Cell Lymphoma (LBCL) Remains on Track"
Large B-cell lymphoma (LBCL) is an aggressive cancer of a type of white blood cell that normally helps fight infections; it forms fast-growing tumors in lymph nodes or other organs. For investors, LBCL matters because it defines a clear market need for treatments, influences clinical trial designs and regulatory decisions, and affects potential sales and valuation for companies developing new drugs, diagnostics, or cell therapies—think of it as a high-priority problem that drives demand for medical solutions.

AI-generated analysis. Not financial advice.

  • 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


FAQ

What did the December 15, 2025 arbitration ruling mean for Allogene (ALLO)?

The tribunal reconfirmed Allogene’s full development and commercial control of cema-cel in the US, EU and UK and cleared a path to obtain full global rights.

How does the arbitration decision affect milestone payments for Allogene (ALLO)?

The tribunal found milestone payments tied to the pivotal trial are due only upon FDA acceptance of a BLA.

Will Allogene (ALLO) own worldwide rights to cema-cel immediately after the ruling?

The ruling cleared the path to obtain full global rights, but remaining steps include completing agreements to acquire those rights.

What license change resulted from the arbitration for Allogene (ALLO)?

The tribunal ordered a partial termination strictly limited to the UCART19 V1 (ALLO-501) product.

When is Allogene (ALLO) expected to report the interim futility analysis for cema-cel?

Allogene expects an interim futility analysis from the ALPHA3 pivotal trial in 1H 2026.

What trial and indication is linked to Allogene’s (ALLO) 1H 2026 catalyst?

A Phase 2 ALPHA3 pivotal trial interim futility analysis of cema-cel in first-line consolidation for large B-cell lymphoma (LBCL).
Allogene Therapeutics

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States
SOUTH SAN FRANCISCO