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‑813 and CNTY-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CNTY‑813 FDA Regulatory Events
CNTY‑813 is a drug developed by Century Therapeutics for the following indication: for patients with type 1 diabetes.
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‑813
- Announced Date:
- April 30, 2026
- Indication:
- for patients with type 1 diabetes.
Announcement
Century Therapeutics, Inc. announced the company will deliver an oral presentation at the American Diabetes Association (ADA) 86th Scientific Sessions, taking place June 5–8, 2026 in New Orleans, Louisiana. The presentation will highlight CNTY-813, Century's iPSC-derived islet cell replacement therapy program engineered with Allo-Evasion™ 5.0 for patients with type 1 diabetes.
AI Summary
Century Therapeutics announced it will deliver an oral presentation at the American Diabetes Association 86th Scientific Sessions, June 5–8, 2026, in New Orleans. The company will highlight CNTY-813, its induced pluripotent stem cell (iPSC)–derived islet cell replacement therapy designed for people with type 1 diabetes. CNTY-813 is engineered with Allo-Evasion™ 5.0, a proprietary approach intended to help the transplanted cells evade immune rejection. The presentation will give attendees a close look at the program’s design and potential to restore insulin-producing cells.
Century’s session offers researchers, clinicians, and industry observers a chance to hear new details about CNTY-813’s approach, rationale, and development plans. The talk may outline preclinical or early clinical findings and the company’s next steps, helping the diabetes community evaluate the therapy’s potential to change how type 1 diabetes is treated.
Read Announcement
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.
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