Cullinan Therapeutics, together with Taiho Oncology and Taiho Pharmaceutical, has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for zipalertinib, an oral epidermal growth factor receptor (EGFR) inhibitor that selectively targets exon 20 insertion mutations in non‑small cell lung cancer (NSCLC). The filing is based on the positive Phase 2b results from the REZILIENT1 trial and is expected to be completed in the first quarter of 2026, with the companies requesting priority review to accelerate the regulatory process.
Zipalertinib is an irreversible, highly selective TKI that binds covalently to the mutant EGFR exon 20 insertion site while sparing wild‑type EGFR, a design that reduces the rash and diarrhea commonly seen with earlier TKIs. In the REZILIENT1 study, the overall response rate (ORR) was 35.2% in the primary efficacy population and 40% in patients who had received only platinum‑based chemotherapy. The median duration of response (mDOR) was 8.8 months, and the drug also showed activity in patients previously treated with the bispecific antibody amivantamab. The FDA has granted zipalertinib Breakthrough Therapy Designation, which is intended to expedite development and review for drugs that address serious conditions with unmet medical needs.
The partnership, formed in 2022, includes a $275 million upfront payment from Taiho to Cullinan and the potential for up to $130 million in milestone payments tied to regulatory approvals. In the United States, the two companies will share profits 50/50. Cullinan’s third‑quarter 2025 financials reported a net loss of $50.61 million, an increase from $40.56 million a year earlier, but the company’s cash runway is projected to extend to 2029 thanks to the partnership structure and its broader pipeline that now includes autoimmune indications.
Zipalertinib could become the first oral therapy for the 4 % of NSCLC patients worldwide who harbor EGFR exon 20 insertions, a subgroup that historically has had limited options beyond the intravenous antibody amivantamab. By offering a convenient oral regimen with a favorable safety profile, the drug could capture a first‑to‑market advantage and generate the company’s first revenue stream, validating its modality‑agnostic development strategy and extending its commercial footprint beyond oncology.
Chief Executive Officer Nadim Ahmed said, “The zipalertinib filing marks a pivotal moment for Cullinan. Our focus on high‑impact targets and the partnership with Taiho gives us the resources and expertise to bring a much‑needed oral therapy to patients who have been underserved.” Chief Medical Officer Jeffrey Jones added, “The REZILIENT1 data confirm that zipalertinib delivers meaningful responses with a manageable safety profile, reinforcing our confidence in its potential to change the treatment landscape for EGFR exon 20 NSCLC.”
The rolling NDA submission positions zipalertinib for a potential priority review, with the goal of achieving FDA approval in 2026. If approved, the drug would fill a critical therapeutic gap and could establish Cullinan as a commercial player in oncology, while the company’s ongoing focus on autoimmune diseases and its diversified pipeline aim to sustain long‑term growth.
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