Cellectis CAR-T Therapy Receives FDA RMAT Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 10 2026
0mins
Source: seekingalpha
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T therapy, lasme-cel, has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating recognition of its potential to address the urgent medical needs of patients with r/r B-ALL, a severe form of leukemia.
- Clinical Data Support: The RMAT designation is backed by Phase 1 BALLI-01 trial data, which demonstrates promising efficacy and a manageable safety profile, thereby enhancing investor confidence in the therapy's prospects.
- Future Presentation Plans: Cellectis is set to present final Phase 1 data for lasme-cel at the 2026 Congress of the European Hematology Association on June 13, which is expected to attract further attention and potentially drive subsequent clinical development.
- Stock Price Reaction: Following the announcement, Cellectis shares rose over 10% in after-hours trading to $3.30, reflecting the market's positive response to the therapy's designation and its potential commercial value.
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Analyst Views on CLLS
Wall Street analysts forecast CLLS stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 3.080
Low
4.00
Averages
7.00
High
9.00
Current: 3.080
Low
4.00
Averages
7.00
High
9.00
About CLLS
Cellectis SA is a France-based company active in the field of genome engineering and genomic surgery. The Company specializes in the research, development, and commercialization of rational genome engineering technologies. The Company develops immunotherapies that aim to force the immune system to target and eradicate cancer cells. It has developed an expertise in combining meganucleases with engineered targeting Deoxyribonucleic Acid (DNA) matrices into Meganuclease Recombination Systems (MRS), used for gene excision, correction or replacement. Cellectis SA markets its technologies mainly for use in the research field, in pharmaceutical drug discovery programs, in the agronomics, bioproduction, and biotherapeutics fields. Cellectis SA operates several subsidiaries. The Company operates in France and the United States, among others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cellectis Presents Final Phase 1 Data from BALLI-01 Trial
- BALLI-01 Trial Results: Cellectis presented final Phase 1 data from the BALLI-01 trial at EHA 2026, showing a 100% overall response rate for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia, with 57% achieving complete remission, highlighting the therapy's significant efficacy.
- Patient Background Analysis: In the BALLI-01 study, 45 patients were treated, with a median of 5 prior lines of therapy in the target population, indicating the potential of this therapy to provide new treatment options for heavily pretreated patients.
- Safety Assessment: Lasme-cel demonstrated a manageable safety profile, with ≥ grade 3 cytokine release syndrome and neurotoxicity occurring in 4% of patients, and all adverse events resolved, indicating its acceptability in clinical use.
- NATHALI-01 Preliminary Data: Cellectis also showcased preliminary data from the NATHALI-01 study, targeting relapsed/refractory B-cell non-Hodgkin lymphoma with eti-cel, revealing an 88% overall response rate and 63% complete response rate, emphasizing the importance of optimizing treatment regimens.
See More
Cellectis CAR-T Therapy Receives FDA RMAT Designation
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T therapy, lasme-cel, has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating recognition of its potential to address the urgent medical needs of patients with r/r B-ALL, a severe form of leukemia.
- Clinical Data Support: The RMAT designation is backed by Phase 1 BALLI-01 trial data, which demonstrates promising efficacy and a manageable safety profile, thereby enhancing investor confidence in the therapy's prospects.
- Future Presentation Plans: Cellectis is set to present final Phase 1 data for lasme-cel at the 2026 Congress of the European Hematology Association on June 13, which is expected to attract further attention and potentially drive subsequent clinical development.
- Stock Price Reaction: Following the announcement, Cellectis shares rose over 10% in after-hours trading to $3.30, reflecting the market's positive response to the therapy's designation and its potential commercial value.
See More
Cellectis Receives FDA RMAT Designation, Stock Soars
- FDA Designation Impact: Cellectis' cell therapy lasmecabtagene timgedleucel has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation based on early-stage trial data, which, while not guaranteeing approval, provides early and frequent interaction with the FDA and potential acceleration of the approval process.
- Stock Reaction: Following the RMAT designation, Cellectis' stock surged over 24% in after-hours trading on Tuesday, indicating strong market recognition of the therapy's potential and reflecting investor optimism about the company's future developments.
- Analyst Rating: Barclays initiated coverage of Cellectis last month with an 'Overweight' rating and a $9 price target, representing a potential upside of approximately 201% from Tuesday's close, further bolstering market confidence in the company's prospects.
- Therapeutic Advantages: Cellectis views lasmecabtagene timgedleucel as a ready-to-use option for heavily pretreated patients, and unlike personalized autologous therapies, its use of healthy donor cells allows for quicker treatment response times, opening up previously inaccessible treatment settings.
See More
Cellectis Receives FDA RMAT Designation for CAR-T Therapy
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T cell therapy, lasmecabtagene timgedleucel (lasme-cel), has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential to address the urgent medical needs of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
- Clinical Trial Data Support: The RMAT designation is backed by promising Phase 1 data from the BALLI-01 trial, which will present final results at the European Hematology Association Congress on June 13, further bolstering market confidence in the therapy's efficacy and safety profile.
- Strategic Implications: Cellectis CEO André Choulika noted that the RMAT designation not only recognizes lasme-cel's potential but also strengthens dialogue with the FDA, facilitating the advancement of the therapy through pivotal clinical trials and enhancing the company's competitive position in the CAR-T market.
- Trial Enrollment Open: The pivotal Phase 2 of the BALLI-01 trial is now open for enrollment, with participant eligibility and clinical center information available on clinicaltrials.gov, marking a significant step forward for Cellectis in the field of cell and gene therapies.
See More
Cellectis to Hold Annual General Meeting on June 25, 2026
- Annual Meeting Announcement: Cellectis has announced that it will hold its annual general meeting on June 25, 2026, at 2:30 p.m. CET at the Biopark auditorium in Paris, aiming to update shareholders on company developments and future strategies.
- Gene Editing Platform Advantage: As a clinical-stage biotechnology company, Cellectis leverages its pioneering gene-editing platform to develop life-saving cell and gene therapies, particularly showcasing unique competitive advantages in CAR T immunotherapies for oncology.
- End-to-End Control Capability: With in-house manufacturing capabilities, Cellectis is one of the few companies that can control the entire value chain of cell and gene therapies, providing it with a significant strategic position in the market.
- Global Business Presence: Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC, demonstrating its global business expansion and market penetration capabilities.
See More
Cellectis Reports Q1 2026 Financial Results and Business Update
- Clinical Trial Progress: Cellectis' BALLI-01 trial for relapsed or refractory B-cell acute lymphoblastic leukemia shows a 100% objective response rate (ORR) in the target population, with the first interim analysis expected in Q4 2026, potentially paving the way for a future Biologics License Application (BLA).
- Favorable Safety Data: In the ALPHA3 trial for cema-cel, 58.3% of patients achieved minimal residual disease (MRD) negativity compared to 16.7% in the control group, with no serious adverse events reported, indicating strong safety and efficacy that could support future commercialization efforts.
- Strong Financial Position: As of March 31, 2026, Cellectis reported $188 million in cash and cash equivalents, providing a runway into Q4 2027; despite a $23 million decrease from 2025, the company demonstrates effective financial management.
- Increased R&D Spending: R&D expenses for Q1 2026 reached $27.2 million, up $5.3 million from the previous year, primarily due to increased personnel and external costs, reflecting the company's commitment to advancing its innovative therapies and enhancing future market competitiveness.
See More
Cellectis Presents Final Phase 1 Data from BALLI-01 Trial
- BALLI-01 Trial Results: Cellectis presented final Phase 1 data from the BALLI-01 trial at EHA 2026, showing a 100% overall response rate for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia, with 57% achieving complete remission, highlighting the therapy's significant efficacy.
- Patient Background Analysis: In the BALLI-01 study, 45 patients were treated, with a median of 5 prior lines of therapy in the target population, indicating the potential of this therapy to provide new treatment options for heavily pretreated patients.
- Safety Assessment: Lasme-cel demonstrated a manageable safety profile, with ≥ grade 3 cytokine release syndrome and neurotoxicity occurring in 4% of patients, and all adverse events resolved, indicating its acceptability in clinical use.
- NATHALI-01 Preliminary Data: Cellectis also showcased preliminary data from the NATHALI-01 study, targeting relapsed/refractory B-cell non-Hodgkin lymphoma with eti-cel, revealing an 88% overall response rate and 63% complete response rate, emphasizing the importance of optimizing treatment regimens.
See More
Cellectis CAR-T Therapy Receives FDA RMAT Designation
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T therapy, lasme-cel, has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, indicating recognition of its potential to address the urgent medical needs of patients with r/r B-ALL, a severe form of leukemia.
- Clinical Data Support: The RMAT designation is backed by Phase 1 BALLI-01 trial data, which demonstrates promising efficacy and a manageable safety profile, thereby enhancing investor confidence in the therapy's prospects.
- Future Presentation Plans: Cellectis is set to present final Phase 1 data for lasme-cel at the 2026 Congress of the European Hematology Association on June 13, which is expected to attract further attention and potentially drive subsequent clinical development.
- Stock Price Reaction: Following the announcement, Cellectis shares rose over 10% in after-hours trading to $3.30, reflecting the market's positive response to the therapy's designation and its potential commercial value.
See More
Cellectis Receives FDA RMAT Designation, Stock Soars
- FDA Designation Impact: Cellectis' cell therapy lasmecabtagene timgedleucel has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation based on early-stage trial data, which, while not guaranteeing approval, provides early and frequent interaction with the FDA and potential acceleration of the approval process.
- Stock Reaction: Following the RMAT designation, Cellectis' stock surged over 24% in after-hours trading on Tuesday, indicating strong market recognition of the therapy's potential and reflecting investor optimism about the company's future developments.
- Analyst Rating: Barclays initiated coverage of Cellectis last month with an 'Overweight' rating and a $9 price target, representing a potential upside of approximately 201% from Tuesday's close, further bolstering market confidence in the company's prospects.
- Therapeutic Advantages: Cellectis views lasmecabtagene timgedleucel as a ready-to-use option for heavily pretreated patients, and unlike personalized autologous therapies, its use of healthy donor cells allows for quicker treatment response times, opening up previously inaccessible treatment settings.
See More
Cellectis Receives FDA RMAT Designation for CAR-T Therapy
- FDA Designation Progress: Cellectis' CD22-targeting CAR-T cell therapy, lasmecabtagene timgedleucel (lasme-cel), has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential to address the urgent medical needs of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
- Clinical Trial Data Support: The RMAT designation is backed by promising Phase 1 data from the BALLI-01 trial, which will present final results at the European Hematology Association Congress on June 13, further bolstering market confidence in the therapy's efficacy and safety profile.
- Strategic Implications: Cellectis CEO André Choulika noted that the RMAT designation not only recognizes lasme-cel's potential but also strengthens dialogue with the FDA, facilitating the advancement of the therapy through pivotal clinical trials and enhancing the company's competitive position in the CAR-T market.
- Trial Enrollment Open: The pivotal Phase 2 of the BALLI-01 trial is now open for enrollment, with participant eligibility and clinical center information available on clinicaltrials.gov, marking a significant step forward for Cellectis in the field of cell and gene therapies.
See More
Cellectis to Hold Annual General Meeting on June 25, 2026
- Annual Meeting Announcement: Cellectis has announced that it will hold its annual general meeting on June 25, 2026, at 2:30 p.m. CET at the Biopark auditorium in Paris, aiming to update shareholders on company developments and future strategies.
- Gene Editing Platform Advantage: As a clinical-stage biotechnology company, Cellectis leverages its pioneering gene-editing platform to develop life-saving cell and gene therapies, particularly showcasing unique competitive advantages in CAR T immunotherapies for oncology.
- End-to-End Control Capability: With in-house manufacturing capabilities, Cellectis is one of the few companies that can control the entire value chain of cell and gene therapies, providing it with a significant strategic position in the market.
- Global Business Presence: Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC, demonstrating its global business expansion and market penetration capabilities.
See More
Cellectis Reports Q1 2026 Financial Results and Business Update
- Clinical Trial Progress: Cellectis' BALLI-01 trial for relapsed or refractory B-cell acute lymphoblastic leukemia shows a 100% objective response rate (ORR) in the target population, with the first interim analysis expected in Q4 2026, potentially paving the way for a future Biologics License Application (BLA).
- Favorable Safety Data: In the ALPHA3 trial for cema-cel, 58.3% of patients achieved minimal residual disease (MRD) negativity compared to 16.7% in the control group, with no serious adverse events reported, indicating strong safety and efficacy that could support future commercialization efforts.
- Strong Financial Position: As of March 31, 2026, Cellectis reported $188 million in cash and cash equivalents, providing a runway into Q4 2027; despite a $23 million decrease from 2025, the company demonstrates effective financial management.
- Increased R&D Spending: R&D expenses for Q1 2026 reached $27.2 million, up $5.3 million from the previous year, primarily due to increased personnel and external costs, reflecting the company's commitment to advancing its innovative therapies and enhancing future market competitiveness.
See More
