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) 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.
Cullinan Therapeutics (Nasdaq: CGEM) reported updated Phase 1 results for CLN-049, an investigational FLT3xCD3 T cell engager, presented orally at the 67th ASH meeting on December 8, 2025. In 45 patients (39 AML) across doses 1.5–12 µg/kg, clinically active doses (≥6 µg/kg) showed a CR/CRh 25% (8/32) and CRc 28% (9/32); at 12 µg/kg CR/CRh was 31% (5/16). Among responders at ≥6 µg/kg, 63% had duration >16 weeks; MRD negativity observed in 3/10 patients with marrow blasts 5%. Safety was manageable: CRS in 35.6% (mostly Grade 1–2), febrile neutropenia 20%. CLN-049 received and dose escalation and expansion cohorts are planned in early 2026.
Cullinan Therapeutics (Nasdaq: CGEM) announced that the U.S. FDA granted Fast Track designation to CLN-049, a FLT3xCD3 T cell engager, for treatment of relapsed/refractory acute myeloid leukemia (R/R AML) on December 1, 2025. The company said Phase 1 data in heavily pre-treated patients showed promising efficacy and favorable safety, including complete responses. CLN-049 Phase 1 results will be presented in an oral presentation at the 67th ASH Annual Meeting on December 8, 2025. Cullinan stated the Fast Track designation is intended to accelerate development and facilitate collaboration with the FDA to advance CLN-049 for patients with limited treatment options.
Cullinan Therapeutics (Nasdaq: CGEM) and partners Taiho Oncology and Taiho Pharmaceutical announced a rolling submission of a New Drug Application to the U.S. FDA for zipalertinib to seek accelerated approval for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion (ex20ins) mutations in patients previously treated with platinum chemotherapy.
The companies said zipalertinib previously received Breakthrough Therapy Designation in 2021. The NDA is based on primary efficacy data from the Phase 1/2 REZILIENT1 trial, with positive results presented at ASCO 2025 and published in the Journal of Clinical Oncology. The firms anticipate completing the NDA submission in Q1 2026 and will request priority review.