Cellectis Receives FDA RMAT Designation, Stock Soars
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Source: stocktwits
- 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.
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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: 2.930
Low
4.00
Averages
7.00
High
9.00
Current: 2.930
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 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 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 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 to Report Q1 2026 Financial Results on May 11
- Earnings Announcement: Cellectis has announced that it will report its Q1 2026 financial results on May 11, 2026, after the US market closes, demonstrating the company's commitment to transparency and timely information disclosure.
- No Conference Call: The company will not host a conference call to discuss the results, although the investor relations team will be available for questions, which may limit direct investor insights into the company's financial health.
- Gene Editing Platform: Cellectis leverages its pioneering gene-editing platform to develop life-saving cell and gene therapies, showcasing its innovative capabilities and market potential in oncology.
- End-to-End Control: As one of the few companies that control the entire value chain of cell and gene therapies, Cellectis' in-house manufacturing capabilities provide a competitive edge and strengthen its market position.
See More
Cellectis Highlights Allogene's Pivotal Trial Progress
- Clinical Trial Progress: Allogene Therapeutics' interim Event-Free Survival analysis from the ALPHA3 trial reveals that 58.3% of patients in the cema-cel arm achieved minimal residual disease (MRD) negativity, compared to 16.7% in the observation arm, indicating significant potential clinical benefits for this therapy in treating large B-cell lymphoma.
- Safety Assessment: As of the data cutoff, cema-cel treatment was generally well-tolerated, with 10 out of 12 patients managed in an outpatient setting post-infusion and no cases of cytokine release syndrome or other serious adverse events, demonstrating its safety in clinical applications.
- Market Potential: Cellectis is eligible for up to $340 million in development and sales milestone payments under the Servier Agreement, along with low double-digit royalties on net sales of cema-cel, highlighting its significant position in the cell therapy market.
- Future Outlook: Allogene anticipates completing study accrual by the end of 2027 and plans an interim Event-Free Survival analysis in mid-2027, with positive results potentially supporting a Biologics License Application (BLA), further advancing the commercialization of cema-cel.
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 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 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 to Report Q1 2026 Financial Results on May 11
- Earnings Announcement: Cellectis has announced that it will report its Q1 2026 financial results on May 11, 2026, after the US market closes, demonstrating the company's commitment to transparency and timely information disclosure.
- No Conference Call: The company will not host a conference call to discuss the results, although the investor relations team will be available for questions, which may limit direct investor insights into the company's financial health.
- Gene Editing Platform: Cellectis leverages its pioneering gene-editing platform to develop life-saving cell and gene therapies, showcasing its innovative capabilities and market potential in oncology.
- End-to-End Control: As one of the few companies that control the entire value chain of cell and gene therapies, Cellectis' in-house manufacturing capabilities provide a competitive edge and strengthen its market position.
See More
Cellectis Highlights Allogene's Pivotal Trial Progress
- Clinical Trial Progress: Allogene Therapeutics' interim Event-Free Survival analysis from the ALPHA3 trial reveals that 58.3% of patients in the cema-cel arm achieved minimal residual disease (MRD) negativity, compared to 16.7% in the observation arm, indicating significant potential clinical benefits for this therapy in treating large B-cell lymphoma.
- Safety Assessment: As of the data cutoff, cema-cel treatment was generally well-tolerated, with 10 out of 12 patients managed in an outpatient setting post-infusion and no cases of cytokine release syndrome or other serious adverse events, demonstrating its safety in clinical applications.
- Market Potential: Cellectis is eligible for up to $340 million in development and sales milestone payments under the Servier Agreement, along with low double-digit royalties on net sales of cema-cel, highlighting its significant position in the cell therapy market.
- Future Outlook: Allogene anticipates completing study accrual by the end of 2027 and plans an interim Event-Free Survival analysis in mid-2027, with positive results potentially supporting a Biologics License Application (BLA), further advancing the commercialization of cema-cel.
See More
