Welcome to our dedicated page for Cullinan Oncology news (Ticker: CGEM), a resource for investors and traders seeking the latest updates and insights on Cullinan Oncology stock.
Cullinan Therapeutics, Inc. develops clinical-stage therapies for autoimmune diseases and cancer, with a pipeline centered on T cell engagers and targeted oncology programs. Recurring news includes updates on CLN-978, a CD19xCD3 T cell engager for autoimmune diseases; velinotamig, a BCMAxCD3 program; CLN-049, a FLT3xCD3 bispecific T cell engager for relapsed or refractory AML and MDS; and zipalertinib for EGFR exon 20 insertion-mutated non-small cell lung cancer.
Company announcements commonly cover clinical data presentations, regulatory submissions and FDA communications, portfolio prioritization, collaborations involving zipalertinib, quarterly financial results, cash runway commentary and healthcare investor conference participation.
Cullinan Therapeutics (Nasdaq: CGEM) announced that the FDA granted Orphan Drug Designation to CLN-049, an investigational FLT3xCD3 T cell engager, for treating relapsed/refractory acute myeloid leukemia (AML). According to Cullinan, this recognizes the unmet need in AML, including TP53-mutated disease, and aligns with promising Phase 1 results.
Cullinan Therapeutics (Nasdaq: CGEM) will present initial Phase 1 clinical data for CLN-978, a subcutaneous CD19xCD3 T cell engager, at the EULAR 2026 Congress in London on June 3-6, 2026.
Data from the OUTRACE RA and OUTRACE SLE studies in treatment-refractory rheumatoid arthritis (RA) and moderate to severe systemic lupus erythematosus (SLE) show single target doses with a favorable safety profile at initial dose levels, robust B cell depletion in blood and tissue, and early signals of clinical activity. Updated data, including additional patients, will be shared in Poster POS1179 on June 6, 2026.
MindWalk Holdings (NASDAQ: HYFT) reported that over 20 drug candidates in partner pipelines originated from its antibody discovery work, with 10 programs now in active Phase 1–3 clinical trials across oncology, immunology, neurology, and infectious disease.
The company highlighted its HYFT® and LensAI™ biological intelligence infrastructure, built on a Knowledge Graph indexing 660 million biological patterns and 25 billion relationships, and a record of 400+ peer-reviewed publications and patents supporting collaborations with firms such as Annexon, argenx, Xencor, Cullinan Oncology, and others.
Cullinan Therapeutics (Nasdaq: CGEM) reported first-quarter 2026 results and provided a corporate update on clinical and regulatory milestones. Cash, cash equivalents, short- and long-term investments, and interest receivable were $393.3 million as of March 31, 2026, providing runway into 2029. Key near-term clinical readouts include initial single-dose CLN-978 data in SLE and RA to be presented at EULAR on June 6, 2026, CLN-049 dose-escalation updates in H2 2026 and RP2D by Q4 2026, and velinotamig multi-dose data in Q4 2026. The U.S. FDA accepted an NDA for zipalertinib with a PDUFA date of February 27, 2027; Cullinan is eligible for up to $130 million in U.S. regulatory milestone payments and a 50/50 U.S. profit share.
Cullinan Therapeutics (Nasdaq: CGEM) announced the FDA has accepted the New Drug Application for zipalertinib to treat locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations; the PDUFA target action date is February 27, 2027.
Support comes from the Phase 2b REZILIENT1 trial: confirmed ORR 35% (n=176) and median duration of response 8.8 months; safety was described as manageable.
Cullinan Therapeutics (Nasdaq: CGEM) reported Q4 and full-year 2025 results and a detailed 2026 clinical and regulatory roadmap. Cash, cash equivalents, investments and interest receivable totaled $439.0 million as of December 31, 2025, providing runway into 2029 under current plans.
Key near-term catalysts: initial CLN-978 data in SLE and RA in Q2 2026, repeat-dosing RA data in Q3 2026, zipalertinib rolling 2L NDA submission completed and REZILIENT3 enrollment finished with top-line by year-end 2026, and CLN-049 advancement toward registrational AML development.
Cullinan Therapeutics (Nasdaq: CGEM) announced management will present at two upcoming investor conferences in early March 2026. CEO Nadim Ahmed and CMO Jeffrey Jones will appear in fireside chats at the TD Cowen 46th Annual Healthcare Conference on March 3 and the Leerink Global Healthcare Conference on March 10. Webcasts will be available under the Events and Presentations section of the company's investor relations website.
Cullinan Therapeutics (Nasdaq: CGEM) will participate in a fireside chat at the Citi 2026 Virtual Oncology Leadership Summit on Thursday, February 19, 2026 at 10:00 a.m. ET. Speakers include CEO Nadim Ahmed and CMO Jeffrey Jones, M.D., M.B.A.
A live webcast will be available under the Events and Presentations section of the company’s investor relations website: https://investors.cullinantherapeutics.com/events.
Cullinan Therapeutics (Nasdaq: CGEM) announced that CEO Nadim Ahmed and CMO Jeffrey Jones, M.D., M.B.A., will take part in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026 at 11:00 a.m. ET.
A live webcast will be available via the company’s investor relations Events and Presentations page at https://investors.cullinantherapeutics.com/events.
Cullinan Therapeutics (Nasdaq: CGEM) provided a 2026 corporate update highlighting clinical and regulatory catalysts and its financial position. Key clinical milestones include planned 2026 data readouts for CLN-978 across RA, SLE and Sjögren’s (single-dose and repeat dosing), initiation of monotherapy expansion and a frontline combination study for CLN-049 with an expected RP2D decision in Q4 2026, and a rolling NDA completion for zipalertinib expected in Q1 2026 with REZILIENT3 enrollment completion in H1 2026. Cullinan reported preliminary cash, cash equivalents and investments of $439.0 million as of Dec 31, 2025, and expects runway into 2029.