Firmonertinib Misses FURVENT PFS Endpoint as ArriVent Loss Widens

The Tip Desk · November 12, 2026 · 3 min read

ArriVent BioPharma (AVBP) reported a $40.3 million net loss, or $0.81 a share, for the three months ended September 30, 2026, as Phase 3 FURVENT missed its primary PFS endpoint.

ArriVent BioPharma, Inc. (AVBP), a clinical-stage company developing firmonertinib and antibody-drug conjugates, reported a net loss of $40.3 million, or $0.81 a share, for the three months ended September 30, 2026, compared with a net loss of $35.0 million, or $0.83 a share, a year earlier.

The loss widened as research and development expenses rose to $38.9 million from $32.2 million and general and administrative expenses increased to $9.5 million from $6.1 million. Operating loss was $43.4 million. Collaboration revenue was $5.0 million, versus none in the year-ago quarter.

The quarter’s defining clinical event was the Phase 3 FURVENT study. Firmonertinib did not meet its primary endpoint of progression-free survival by blinded independent central review. At 240 mg, median PFS was 11.0 months versus 9.5 months with chemotherapy (HR 0.75; p=0.0654), and the confirmed objective response rate by BICR was 60% versus 33%. The company said it is reviewing the full dataset, including differences between BICR and investigator-assessed PFS in the chemotherapy arm, to inform potential next steps.

Chief Executive Bing Yao said enrollment remains on track for the global Phase 3 ALPACCA trial in first-line EGFR PACC-mutant NSCLC, where firmonertinib 240 mg is being compared with investigator’s choice of osimertinib or afatinib. ALPACCA includes an interim analysis of objective response rate to support a potential accelerated-approval pathway, with PFS assessed for potential full approval. The company plans to provide an update on firmonertinib in the first quarter of 2027 around the review of FURVENT.

The antibody-drug conjugate pipeline continued to move. Preliminary Phase 1 data for ARR-217 (MRG007), a CDH17-targeted ADC in partnership with Lepu Biopharma, were presented at ESMO Congress 2026. In evaluable patients with colorectal cancer treated at 6 mg/kg, the objective response rate, including confirmed and unconfirmed responses, was 44.8% and the disease control rate was 93.1%. Adverse events were predominantly low-grade gastrointestinal and hematologic toxicities. Phase 1b dose optimization and expansion are ongoing. Phase 1b dose-optimization data in late-line colorectal cancer are expected in the first half of 2027, with combination data later in the year.

ArriVent also dosed the first patient in a U.S. Phase 1a/1b first-in-human study of ARR-002, a dual-target MUC16/NaPi2b tetravalent ADC, with initial focus in ovarian and endometrial cancers.

On the corporate side, the company named Priti Patel, M.D., M.S., as Chief Medical Officer. Co-founder Stuart Lutzker, M.D., Ph.D., who had served as President of Research and Development and on the board, announced his retirement.

Cash and investments were $393.2 million as of September 30, 2026, versus $373.1 million as of June 30, 2026. The company said the cash is expected to fund operations to mid-2028.

For the nine months ended September 30, 2026, net cash used in operations was $122.2 million, versus $129.9 million a year earlier. Research and development expenses were $118.9 million and $121.2 million, respectively. General and administrative expenses were $28.3 million and $17.5 million. Net loss for the nine months was $133.5 million, or $2.82 a share, versus $130.8 million, or $3.54 a share.

The company said it is conducting a detailed review of FURVENT to better understand the totality of the data, with a firmonertinib update planned in the first quarter of 2027.