Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
CGEM Catalyst Timeline
Dated clinical, regulatory and corporate events for Cullinan Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Cullinan Therapeutics, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How CGEM actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-13 | zipalertinib plus chemotherapy | Phase 3 data presentation | Phase 3 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CLN-619 Small moleculeNCT05117476 | Advanced Solid Tumor | Phase 1 | ACTIVE NOT_RECRUITING | 440 | Jun 1, 2026 |
Clinical Trial Results
Readouts, endpoints and source filings for every CGEM program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| zipalertinib Breakthrough | non-small cell lung cancer | Phase 3 | 2026-09-13 | 6-Month Median Progression-Free Survival BenefitRead More | Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung CancerRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Michaelson JenniferOfficer (Chief Scientific Officer) | Option | 4,000 166,844 held | $4.30 | 09/08/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in CGEM
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| BIOIMPACT CAPITAL LLC | 10.8 % (28.6 %) | 177.21 M | 9.73 M | 27.24% ( 2.08 M) |
CGEM Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2027-01-15 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How CGEM ranks across every disease it competes in
CGEM News
Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia
Cullinan Therapeutics has announced the dosing of the first patient in its pivotal Phase 2 study of CLN-049, aimed at treating relapsed/refractory acute myeloid leukemia (AML). This investigational FLT3 T cell engager is designed to target FLT3-expressing leukemia cells, providing a new treatment avenue for patients with limited options. The study follows a successful End-of-Phase 1 meeting with the FDA and includes an exploratory cohort for TP53-mutated AML.
Read more →New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program
Cullinan Therapeutics has initiated a New Drug Application for zipalertinib in combination with chemotherapy for treating EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC). This submission follows the promising results from the Phase 3 REZILIENT3 study, which showed significant improvement in progression-free survival. The NDA is being reviewed under the FDA's Real-Time Oncology Review program, with completion expected by late 2026.
Read more →Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio
Cullinan Therapeutics has outlined significant milestones for Q4 2026, focusing on its T cell engager portfolio in immunology and oncology. Key updates include multi-dose regimen data for CLN-978 and velinotamig, as well as CLN-049's Phase 1 study results. The company anticipates sharing comprehensive data at the ACR Convergence 2026 event and progressing towards a Phase 2 study for CLN-049.
Read more →Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum
Cullinan Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the Stifel 2026 Virtual Immunology and Inflammation Forum. CEO Nadim Ahmed and CMO Jeffrey Jones will engage in a fireside chat on September 24, 2026. The event highlights Cullinan's commitment to developing innovative T cell engagers for autoimmune diseases and cancer.
Read more →Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer
Cullinan Therapeutics is hosting a virtual analyst and investor event to discuss the interim analysis results of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy. The results will be presented at the IASLC 2026 World Conference on Lung Cancer. Key executives will participate in the event, which will be available via live webcast.
Read more →Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics announced positive results from the Phase 3 REZILIENT3 trial. The trial evaluated zipalertinib combined with chemotherapy against chemotherapy alone for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer. The findings indicate a significant median progression-free survival benefit for the combination treatment.
Read more →Cullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer
Cullinan Therapeutics will host a virtual analyst and investor event on September 14, 2026, to discuss the interim analysis results of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy for NSCLC. The trial met its primary endpoint of progression-free survival, and results will be presented at the IASLC 2026 World Conference on Lung Cancer. Key executives will participate in the event.
Read more →Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer
The Phase 3 REZILIENT3 trial results for Zipalertinib combined with chemotherapy have been selected for presentation at the IASLC 2026 World Conference on Lung Cancer. The interim analysis indicates that the trial successfully met its primary endpoint of progression-free survival in patients with EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC).
Read more →Zipalertinib Plus Chemotherapy Meets Primary Endpoint of Progression-Free Survival in Planned Interim Analysis of Phase 3 REZILIENT3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics announced that their Phase 3 REZILIENT3 trial has successfully met its primary endpoint of progression-free survival. This trial evaluates the efficacy of zipalertinib in combination with chemotherapy for patients with EGFR Exon 20 insertion mutation non-small cell lung cancer. The results from this interim analysis are promising for future treatment options.
Read more →Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results
Cullinan Therapeutics provided a corporate update highlighting promising data for its T cell engagers CLN-978 and velinotamig, with plans for Phase 2 studies in 2027. The company reported a net loss of $53.7 million for Q2 2026 but maintains a strong cash position of $356 million, ensuring operational runway into 2029. Upcoming data presentations are expected to further inform the clinical potential of their therapies.
Read more →Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML
Cullinan Therapeutics announced positive feedback from the FDA regarding its CLN-049 program during an End-of-Phase 1 meeting. The company plans to initiate a potentially registrational Phase 2 study for CLN-049 in patients with relapsed/refractory acute myeloid leukemia (AML) in Q3 2026. The FDA's feedback supports the development strategy and highlights the urgent need for new treatments in this area.
Read more →Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases
Cullinan Therapeutics has reported promising clinical data for its T cell engager programs, CLN-978 and velinotamig, targeting autoimmune diseases like systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). The data indicates significant efficacy, including clinical remissions and renal responses in patients. The company plans to expand its clinical trials and present further data in the coming months.
Read more →Cullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 Congress
Cullinan Therapeutics presented initial clinical data for CLN-978, a CD19xCD3 T cell engager, at the EULAR 2026 Congress. The data indicates significant clinical benefits, including remissions in patients with systemic lupus erythematosus and rheumatoid arthritis following treatment. Alongside a favorable safety profile and substantial B cell depletion, the data support CLN-978’s potential as a novel therapeutic option. Further studies are planned to advance the development of CLN-978 for these challenging-to-treat autoimmune conditions.
Read more →Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager
Cullinan Therapeutics will host an Immunology Day event on June 10, 2026, in New York City to present new clinical data for its autoimmune disease therapies, CLN-978 and Velinotamig. Initial results from over 30 patients involved in systemic lupus erythematosus and rheumatoid arthritis studies will be shared. The event is aimed at analysts and institutional investors, featuring discussions led by prominent clinical experts. The company aims to provide insights into data milestones and its global development strategy.
Read more →Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
Cullinan Therapeutics has received FDA Orphan Drug Designation for CLN-049, a novel FLT3xCD3 T cell engager, aimed at treating relapsed/refractory acute myeloid leukemia (AML). This designation underscores the urgent need for new therapies in AML, particularly for patients with TP53 mutations. CLN-049 is currently being evaluated in ongoing Phase 1 clinical trials.
Read more →Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress
Cullinan Therapeutics announced the presentation of initial clinical data for CLN-978 at the EULAR 2026 Congress. The data, from ongoing Phase 1 studies, indicates a favorable safety profile and early signs of clinical activity in patients with treatment-refractory rheumatoid arthritis and systemic lupus erythematosus. The findings will be shared in detail during the congress in London.
Read more →Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results
Cullinan Therapeutics provided a corporate update and reported its Q1 2026 financial results. The company announced initial clinical data for its CD19 T cell engager, CLN-978, to be presented at the EULAR 2026 Congress. Additionally, the FDA accepted the NDA for zipalertinib, with a target action date of February 27, 2027. Cullinan's financial position remains strong, with cash reserves expected to last into 2029.
Read more →U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
The FDA has accepted a New Drug Application for zipalertinib, a treatment for locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. This acceptance is based on positive results from the Phase 2b REZILIENT1 clinical trial, which demonstrated a 35% objective response rate. The PDUFA target action date is set for February 27, 2027.
Read more →Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Cullinan Therapeutics has announced its fourth quarter and full year 2025 financial results alongside several key updates. Initial clinical data for their therapy CLN-978 for systemic lupus erythematosus and rheumatoid arthritis is slated for release in Q2 2026. Furthermore, the company has completed its rolling NDA submission for zipalertinib, with expectations for significant data releases throughout 2026. Despite a growing cash position of $439 million, the company reported increasing net losses and R&D expenses, highlighting both potential progress and financial challenges.
Read more →Cullinan Therapeutics to Participate in Upcoming Investor Conferences
Cullinan Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in upcoming investor conferences. The company focuses on developing first- or best-in-class therapies for autoimmune diseases and cancer. Webcasts of the events will be available on their investor relations website, showcasing their commitment to innovation in healthcare.
Read more →