Cullinan Therapeutics (CGEM) has upcoming FDA regulatory milestones for zipalertinib. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Cullinan Therapeutics (CGEM).
Over the past two years, Cullinan Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
zipalertinib and CLN-978. 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.
Zipalertinib FDA Regulatory Timeline and Events
Zipalertinib is a drug developed by Cullinan Therapeutics for the following indication: For patients with heavily pre-treated EGFR ex20ins mutation NSCLC.
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:
- zipalertinib
- Announced Date:
- April 28, 2026
- Target Action Date:
- February 27, 2027
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, announced that The Prescription Drug User Fee Act (PDUFA)target action date is February 27, 2027.
AI Summary
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics announced that the Prescription Drug User Fee Act (PDUFA) target action date for zipalertinib is February 27, 2027. This date is when the U.S. FDA is expected to complete its review and potentially issue a decision on the regulatory application.
Zipalertinib is an oral EGFR tyrosine kinase inhibitor being developed for patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) that harbors EGFR exon 20 insertion mutations, specifically for those previously treated with platinum‑based systemic chemotherapy. Taiho leads global development and collaborates with Cullinan in the United States.
The announced PDUFA date establishes a clear regulatory timeline for stakeholders and patients awaiting a new targeted option. The companies will continue to work with regulators and share additional data as the review proceeds toward the February 27, 2027 action date.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- April 28, 2026
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab.
AI Summary
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics announced that the U.S. Food and Drug Administration has accepted a New Drug Application (NDA) for zipalertinib. The filing seeks approval to treat patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations and whose disease has progressed on or after platinum‑based chemotherapy, with or without prior treatment with amivantamab.
Zipalertinib is an oral EGFR tyrosine kinase inhibitor in development by Taiho Oncology and Taiho Pharmaceutical, in collaboration with Cullinan Therapeutics in the U.S. FDA acceptance of the NDA begins the agency’s formal review process and, if approved, could offer a new targeted treatment option for patients with this specific and hard‑to‑treat form of NSCLC. The companies will continue to work with regulators as the review proceeds.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- November 20, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. announced the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy.
AI Summary
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics have begun a rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of zipalertinib. Zipalertinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor being developed to treat adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations and who previously received platinum‑based systemic chemotherapy.
The NDA is supported by primary efficacy data from REZILIENT1, a Phase 1/2 trial of zipalertinib (CLN‑081/TAS6417) monotherapy in this patient population. In the trial patients received 100 mg twice daily; key endpoints included objective response rate and duration of response assessed by independent central review, with safety evaluated per standard criteria. Positive REZILIENT1 results were presented at ASCO 2025 and published in the Journal of Clinical Oncology. The companies expect to complete the rolling submission in the first quarter of 2026 and will request priority review.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- October 12, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations and CNS involvement.
AI Summary
Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. reported new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study. This trial tests zipalertinib, a pill that blocks abnormal EGFR proteins, in advanced or metastatic non-small cell lung cancer (NSCLC) patients whose tumors carry EGFR exon 20 insertion or other rare mutations and have spread to the brain.
As of February 2025, 32 patients received 100 mg of zipalertinib twice daily. In 16 patients with measurable brain metastases, the intracranial response rate was 31.3%, including one complete response. Disease control in the brain was 68.8%, with a median response duration of 8.1 months. Systemic response rate was 27.6% and lasted a median of 7.6 months, matching brain activity.
Zipalertinib was generally well tolerated. Twenty-five percent of patients experienced serious side effects, mainly anemia and lung inflammation, and there was one treatment-related death from lung inflammation. No new safety concerns emerged.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- September 9, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC).
AI Summary
Taiho Oncology and Cullinan Therapeutics announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib in advanced or metastatic non-small cell lung cancer.
In REZILIENT1, 84 patients with NSCLC harboring EGFR exon 20 insertions who had prior amivantamab treatment received zipalertinib 100 mg twice daily. The objective response rate (ORR) was 27.4% overall, rising to 31.5% in patients treated only with amivantamab. The median duration of response was 8.5 months, and disease control rate reached 84.5%. Safety results showed manageable side effects, with common events including paronychia, anemia, and rash.
REZILIENT2 enrolled 40 patients with uncommon non-ex20ins EGFR mutations. Zipalertinib showed a 30% ORR, 70% disease control rate, and a median response of 7.8 months. Side effects were mainly mild skin and blood toxicities. These results support further studies of zipalertinib in EGFR-mutant NSCLC.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- July 22, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain.
AI Summary
Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. will present new data on zipalertinib at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, on September 6–9, 2025. These findings come from the REZILIENT1 and REZILIENT2 Phase 2 trials in non-small cell lung cancer (NSCLC).
Updated efficacy and safety results from the REZILIENT1 trial will focus on patients with EGFR exon 20 insertion mutations who were previously treated with amivantamab. This Phase 2b study highlights zipalertinib’s potential against this hard-to-treat subgroup.
Preliminary data from the REZILIENT2 trial will report on a parallel cohort of patients with uncommon, non-exon 20 insertion EGFR mutations. Together, these results may support the role of zipalertinib in treating NSCLC with less common EGFR variants. Both studies will be featured as mini oral presentations at the conference. Abstract details will be available on the conference website on August 13, 2025.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- June 1, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO).
AI Summary
Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced the positive publication of the REZILIENT1 trial results in the Journal of Clinical Oncology. This Phase 1/2 global study evaluated the use of zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had already received prior treatments. The trial’s findings show a meaningful clinical response, with an overall objective response rate of about 35% and a median duration of response around 8.8 months in the primary group of 176 patients. These promising results suggest that zipalertinib may offer a new targeted therapy option for those with advanced or metastatic NSCLC, addressing an area of significant unmet need in treatment. Additional details and data from the trial will also be shared during an oral presentation at the upcoming ASCO Annual Meeting.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- January 28, 2025
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate.
AI Summary
Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc. have announced promising results from the REZILIENT1 trial. This Phase 1/2 study evaluated zipalertinib (CLN-081/TAS6417) as a monotherapy in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations who had previously received treatment. The trial successfully met its primary endpoint by achieving a significant overall response rate. The data were obtained from the Phase 2b segment of the trial, and the safety profile observed was consistent with earlier findings. Full results will be presented at an upcoming international medical conference, highlighting the potential of zipalertinib to address the needs of patients facing limited treatment options.
Read Announcement- Drug:
- zipalertinib
- Announced Date:
- September 14, 2024
- Indication:
- For patients with heavily pre-treated EGFR ex20ins mutation NSCLC
Announcement
Cullinan Therapeutics, updated data in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations receiving zipalertinib after prior treatment with amivantamab enrolled in Module C of its pivotal Phase 2b REZILIENT1 clinical trial.
AI Summary
Cullinan Therapeutics released updated results from Module C of its pivotal Phase 2b REZILIENT1 clinical trial. The study focused on patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had already been treated with amivantamab. In the trial, zipalertinib demonstrated an objective response rate of 40% among 30 evaluable patients, with 3% achieving a complete response and 37% a partial response. About 50% of the patients experienced stable disease, indicating consistent anti-tumor activity. The safety profile of zipalertinib remained manageable, with common adverse events such as rash, paronychia, and anemia mostly being mild to moderate. The favorable outcomes were similar to earlier study parts where patients received chemotherapy, reinforcing confidence in zipalertinib's potential for heavily pre-treated NSCLC patients. Additionally, the trial enrollment was completed ahead of schedule.
Read Announcement
CLN-978 FDA Regulatory Timeline and Events
CLN-978 is a drug developed by Cullinan Therapeutics for the following indication: To Treat Systemic Lupus Erythematosus.
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:
- CLN-978
- Announced Date:
- October 25, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, will present new preclinical data for CLN-978, its novel investigational CD19xCD3 bispecific T cell engager.
AI Summary
Cullinan Therapeutics will present new preclinical data for CLN-978 at ACR Convergence 2025 in Chicago on October 28 in a poster session. CLN-978 is a novel CD19xCD3 bispecific T cell engager designed to deeply deplete B cells in autoimmune diseases.
In lab tests with human immune cells from patients with rheumatoid arthritis, Sjögren’s disease, and lupus, CLN-978 rapidly and specifically killed B cells while activating T cells. These results matched those seen in healthy donor cells.
In nonhuman primates, subcutaneous CLN-978 caused dose-dependent, long-lasting B cell depletion in blood, bone marrow, and lymph nodes without serious side effects. This suggests it could work well in patients.
In a mouse lupus model, treatment reduced harmful antibodies in blood and kidney, showing potential to modify disease. CLN-978’s small size and albumin binding support easy subcutaneous dosing in ongoing OUTRACE clinical trials.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- May 8, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics announced that it received approval from European Medicines Agency (EMA) for CLN-978
AI Summary
Cullinan Therapeutics announced that it has received approval from the European Medicines Agency (EMA) to begin a Phase 1 trial of its T cell engager, CLN-978, for patients with active, difficult-to-treat rheumatoid arthritis. The study is set to start in Q2 2025 at major trial centers in Germany and Italy, marking an important step in developing targeted therapies for autoimmune diseases.
This EMA approval supports Cullinan’s commitment to advance treatment options in the autoimmune field. The company is also progressing its studies of CLN-978 in patients with systemic lupus erythematosus and Sjögren’s disease, with additional data anticipated later this year or early next year. The initiative reinforces Cullinan's role in pioneering innovative medicines to address challenging autoimmune conditions.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 29, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S.
AI Summary
Cullinan Therapeutics has announced the start of a U.S. study to evaluate its novel therapeutic, CLN-978, in patients with moderate to severe Sjögren’s disease. This study will enroll patients who meet the 2016 ACR/EULAR classification criteria and test positive for anti-SSA/RO antibodies or rheumatoid factor. The trial will use a dose escalation scheme similar to previous studies, with the primary goal of assessing the safety and tolerability of CLN-978 in this patient group. Additionally, researchers will explore secondary outcomes such as pharmacokinetics, pharmacodynamics, immunogenicity, and CLN-978’s overall effect on disease activity. This new study is designed to address the significant unmet needs of individuals living with Sjögren’s disease, a condition marked by chronic pain, fatigue, and other systemic complications, potentially offering a new, convenient subcutaneous treatment option.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 16, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025
AI Summary
Cullinan Therapeutics announced that a company-sponsored clinical trial will begin in the second quarter of 2025 at two leading European research centers: FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome, Italy. The trial will study CLN-978, a novel CD19-targeting bispecific T cell engager, and aims to evaluate its safety, dosing, and overall effectiveness in treating autoimmune diseases.
This initiative is part of a broader global clinical development plan, with additional studies already underway in the U.S., Europe, and Australia focusing on systemic lupus erythematosus. The research aims to address the significant treatment gap for patients with difficult-to-treat autoimmune conditions by offering a potentially more accessible, off-the-shelf subcutaneous therapy that could improve disease management and patient quality of life.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- April 16, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, announced that the European Medicines Agency (EMA) approved the Company's Clinical Trial Application (CTA) for CLN-978.
AI Summary
Cullinan Therapeutics recently reached a significant milestone when the European Medicines Agency (EMA) approved its Clinical Trial Application (CTA) for CLN-978. This clearance allows the company to begin a Phase 1 open-label clinical trial in the second quarter of 2025 in two European centers: FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome. The trial will focus on patients with active, treatment-resistant rheumatoid arthritis, assessing safety, pharmacokinetics, pharmacodynamics, and the drug’s effects on disease activity.
CLN-978 is a novel, CD19-targeting T cell engager that offers potential benefits in managing autoimmune conditions, including rheumatoid arthritis and systemic lupus erythematosus. This regulatory step is a key part of Cullinan’s global development plan, which aims to provide convenient, off-the-shelf, subcutaneous treatments that could improve therapy flexibility and outcomes for patients in need of better treatment options.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- February 27, 2025
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, reported recent and anticipated business highlights
AI Summary
Cullinan Therapeutics reported recent and upcoming milestones that underscore its leadership in targeted therapies. The company highlighted CLN-978 as the first and only development-stage CD19 T cell engager with FDA IND clearance for autoimmune diseases in the U.S. Initial clinical data from the global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) is expected by the fourth quarter of 2025, and a Phase 1 study in rheumatoid arthritis is set to launch in the second quarter of 2025. Additionally, the pivotal Phase 2b portion of the REZILIENT1 study for zipalertinib, an EGFR exon20 insertion inhibitor, met its primary endpoint, boosting optimism for its use in NSCLC patients. Full results for zipalertinib are anticipated by mid-2025, with an NDA submission planned for the second half of 2025 after further discussions with the FDA.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 17, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, today received Human Research Ethics Committee (HREC) approval in Australia to initiate its global Phase 1 clinical trial to evaluate CLN-978, its CD19xCD3 bispecific T cell engager, for the treatment of systemic lupus erythematosus (SLE).
AI Summary
Cullinan Therapeutics recently received approval from Australia’s Human Research Ethics Committee (HREC) to start its global Phase 1 clinical trial of CLN-978, a CD19xCD3 bispecific T cell engager. This early-stage trial is designed to evaluate the safety, pharmacokinetics, and initial clinical activity of CLN-978 in patients with systemic lupus erythematosus (SLE).
SLE is a chronic autoimmune disease that affects hundreds of thousands of people worldwide, often requiring lifelong immune suppression. CLN-978 is developed to target B cells by binding to CD19, aiming to deliver a potent T cell response with convenient, off-the-shelf dosing. The trial will be conducted at multiple international sites, starting in Australia, and represents an important step in Cullinan’s global push to bring innovative treatment options to patients suffering from autoimmune conditions like SLE.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 17, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics, Inc today received Human Research Ethics Committee (HREC) approval in Australia to initiate its global Phase 1 clinical trial to evaluate CLN-978, its CD19xCD3 bispecific T cell engager, for the treatment of systemic lupus erythematosus (SLE)..
AI Summary
Cullinan Therapeutics has received Human Research Ethics Committee (HREC) approval in Australia to begin its global Phase 1 clinical trial for CLN-978, a novel CD19xCD3 bispecific T cell engager aimed at treating systemic lupus erythematosus (SLE). This early-stage study will assess the safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients, who currently rely on lifelong immune suppression since existing treatments rarely achieve treatment-free remissions.
The trial, which will be conducted at multiple sites in Australia and other countries, focuses on determining whether CLN-978 can provide a convenient, off-the-shelf therapeutic option. Designed to efficiently target B cells with low levels of CD19, CLN-978 features a half-life extended construct that could potentially reduce toxicity and enhance patient dosing. This approval marks a critical step in Cullinan’s efforts to develop transformative therapies for autoimmune diseases like SLE.
Read Announcement- Drug:
- CLN-978
- Announced Date:
- September 16, 2024
- Indication:
- To Treat Systemic Lupus Erythematosus
Announcement
Cullinan Therapeutics today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE).
AI Summary
Cullinan Therapeutics, Inc. announced that it has filed an Investigational New Drug (IND) application with the FDA to evaluate its novel CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). This development is an important step in their efforts to address the needs of over 160,000 patients in the U.S. who suffer from SLE. Unlike current treatments that rely on lifelong immune suppression, CLN-978 is designed to potentially modify the course of the disease.
CLN-978 works by targeting CD19-positive cells, including those with very low levels of CD19, and features a half-life–extending design that may allow for subcutaneous delivery. Cullinan hopes that this therapy could offer a more convenient, off-the-shelf option that delivers potent and disease-modifying effects, ultimately improving the quality of life for patients with SLE.
Read Announcement
