FDA Events for Century Therapeutics (IPSC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Century Therapeutics (IPSC).
Over the past two years, Century Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CNTY-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CNTY-101 - FDA Regulatory Timeline and Events
CNTY-101 is a drug developed by Century Therapeutics for the following indication: Relapsed or refractory CD19 positive B-cell malignancies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CNTY-101
- Announced Date:
- May 28, 2025
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics, Inc. announced two presentations at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is being held from June 11-14, 2025, at Fira de Barcelona in Barcelona, Spain.
AI Summary
Century Therapeutics, Inc. has announced that it will present two sessions at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress. The event will be held from June 11-14, 2025, at Fira de Barcelona in Barcelona, Spain. The first presentation, led by Dr. Hongxia Zhang, will feature CNTY-101, an iPSC-derived allogeneic CD19 targeting CAR-NK product. This session will highlight the robust B cell depletion exhibited by CNTY-101 and its broad potential for development in B cell-induced autoimmune diseases. The second presentation, by Dr. Jonathan Kurtz, is set to discuss the generation of iPSC-derived CAR-NK, γδ CAR-T, and αβ CAR-T cells with strong activity against autoimmune conditions. More details and presentation materials will be available on the EULAR Congress website and via Century Therapeutics’ online scientific resources after the event.
Read Announcement- Drug:
- CNTY-101
- Announced Date:
- March 19, 2025
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics, Inc provided business highlights for the full year 2024..
AI Summary
Century Therapeutics provided its full year 2024 business highlights, emphasizing a strategic pipeline re-prioritization focused on four transformative programs. The company is advancing CNTY-308, a CD19-targeted CAR-iT cell therapy engineered with its proprietary Allo-Evasion™ 5.0 technology. CNTY-308 is being developed for B-cell-mediated autoimmune diseases and malignancies, and its preclinical performance suggests it could be comparable to existing autologous CAR-T therapies. IND-enabling studies for CNTY-308 are anticipated to begin in mid-2025, moving the therapy toward product candidate selection. Additionally, the company refined its clinical focus for CNTY-101, with clinical data expected in 2025 from its CALiPSO-1 Phase 1 trial. With a strong cash position of $220.1 million extending operations into the fourth quarter of 2026, Century Therapeutics is well positioned to drive these key initiatives forward.
Read Announcement- Drug:
- CNTY-101
- Announced Date:
- January 21, 2025
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics, Inc announced that it has entered into an agreement for an investigator-initiated Phase 1/2 trial by Professors Georg Schett and Andreas Mackensen of its CD19 CAR-iNK investigational cell therapy candidate CNTY-101 in patients with B-cell mediated autoimmune diseases.
AI Summary
Century Therapeutics, Inc. announced that it has entered into an agreement for an investigator-initiated Phase 1/2 trial led by Professors Georg Schett and Andreas Mackensen at Friedrich-Alexander University Erlangen-Nürnberg. The trial will evaluate CNTY-101, an allogeneic CD19 CAR-iNK cell therapy candidate, in patients with B-cell mediated autoimmune diseases. The study, known as the CARAMEL trial, will assess the safety, efficacy, and key translational data of CNTY-101 in conditions such as systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy, and diffuse cutaneous systemic sclerosis.
Led by renowned pioneers in the field, the Schett/Mackensen group’s initiative represents the first exploration of an off-the-shelf, iPSC-derived NK cell therapy for autoimmune indications. This collaboration highlights the promise of CNTY-101 in addressing significant unmet needs in autoimmune disease treatment by potentially overcoming hurdles related to traditional cell therapies.
Read Announcement- Drug:
- CNTY-101
- Announced Date:
- June 3, 2024
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics v
AI Summary
Century Therapeutics has reported promising interim results from its ongoing Phase 1 ELiPSE-1 study of CNTY-101 in patients with relapsed or refractory non-Hodgkin lymphoma. CNTY-101 is an innovative, allogeneic, iPSC-derived natural killer cell therapy that targets CD19 and employs six precise gene edits through the company’s proprietary Allo-Evasion™ technology. This technology allows repeated dosing without the need for continued lymphodepletion.
The study has shown CNTY-101 to have a manageable safety profile, with no dose-limiting toxicities or graft-versus-host disease observed, even at higher doses. Notably, the majority of patients received treatment in an outpatient setting. A novel cell-free DNA method demonstrated that CNTY-101 persists outside the bloodstream. Enrollment continues as the trial explores additional dosing schedules, further supporting the potential of this novel cell therapy in treating high-risk B-cell malignancies.
Read Announcement- Drug:
- CNTY-101
- Announced Date:
- May 10, 2024
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics announced two poster presentations at the ASGCT 27th Annual Meeting.
AI Summary
Century Therapeutics announced that it is set to present two poster presentations at the ASGCT 27th Annual Meeting. The company plans to showcase its latest research and insights into innovative cell therapy approaches, highlighting significant advancements in its therapeutic strategies. These posters will detail new studies that emphasize their progress in refining manufacturing processes and optimizing cell-based treatments, which could have a profound impact on patient outcomes.
Experts believe that these presentations will contribute valuable information regarding the development and clinical potential of cell therapies. With the ASGCT conference providing a prestigious platform, Century Therapeutics aims to strengthen its position in the competitive field of biotechnology. The event is expected to facilitate discussions among industry leaders, potentially leading to further collaborations and a better understanding of emerging therapies.
Read Announcement- Drug:
- CNTY-101
- Announced Date:
- April 11, 2024
- Indication:
- Relapsed or refractory CD19 positive B-cell malignancies
Announcement
Century Therapeutics announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications
AI Summary
Century Therapeutics has announced plans to expand the clinical development of its lead cell therapy program, CNTY-101, into additional autoimmune disease indications. CNTY-101 is a CD19-targeting, iPSC-derived iNK cell therapy that uses Century’s Allo-Evasion™ technology to allow repeat dosing without the need for continuous lymphodepletion. This expanded focus comes after promising preclinical data showing that CNTY-101 can effectively target B-cells, including those from patients with autoimmune diseases like systemic lupus erythematosus (SLE). Although the CALiPSO-1 trial for moderate to severe SLE is set to start in early 2024, Century now plans to pursue regulatory filings for CNTY-101 in other autoimmune conditions with limited treatment options. These efforts are part of Century’s broader strategy to address significant unmet medical needs in the autoimmune disease area with innovative cell therapy solutions.
Read Announcement
Century Therapeutics FDA Events - Frequently Asked Questions
As of now, Century Therapeutics (IPSC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Century Therapeutics (IPSC) has reported FDA regulatory activity for CNTY-101.
The most recent FDA-related event for Century Therapeutics occurred on May 28, 2025, involving CNTY-101. The update was categorized as "Presentation," with the company reporting: "Century Therapeutics, Inc. announced two presentations at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, which is being held from June 11-14, 2025, at Fira de Barcelona in Barcelona, Spain."
Currently, Century Therapeutics has one therapy (CNTY-101) targeting the following condition: Relapsed or refractory CD19 positive B-cell malignancies.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IPSC) was last updated on 7/10/2025 by MarketBeat.com Staff
