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FDA Accepts SMMT's Application Seeking Approval for NSCLC Drug
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Key Takeaways
SMMT's FDA-accepted BLA seeks approval of ivonescimab plus chemo for NSCLC after third-generation EGFR-TKIs.
SMMT faces Nov. 14, 2026, PDUFA date, with FDA planning mid- and late-cycle reviews and labeling talks.
SMMT's BLA is backed by the phase III HARMONi data that met PFS, while OS missed but trended favorably.
Summit Therapeutics (SMMT - Free Report) announced that the FDA has accepted its biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with third-generation EGFR-TKIs.
The regulatory body has set a target action date of Nov. 14, 2026.
The FDA plans to conduct a comprehensive review of the application, including mid-cycle and late-cycle meetings. If no major issues arise, labeling discussions may take place prior to the PDUFA action date.
Over the past year, shares of Summit have declined 28.4% compared with the industry’s 1.3% fall.
Image Source: Zacks Investment Research
The BLA submission was based on data from the phase III HARMONi study evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC post EGFR-TKI therapy.
The study met one of its two primary endpoints — progression-free survival. Although the study did not meet the overall survival (OS) endpoint, which the FDA had previously identified as a key requirement for filing, the data showed a favorable trend toward OS.
More on SMMT’s Ivonescimab
Ivonescimab is a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. The candidate is being developed in collaboration with China-based Akeso. The company licensed ivonescimab from Akeso in January 2023. Summit is currently conducting three late-stage studies, HARMONi, HARMONi-3, and HARMONi-7, to evaluate ivonescimab in separate settings for NSCLC indication.
Ivonescimab was earlier granted Fast Track designation by the FDA for the HARMONi study.
Additionally, SMMT expanded the development of ivonescimab beyond NSCLC by initiating enrollment in a separate phase III HARMONi-GI3 study in late 2025. The study will evaluate the drug in combination with chemotherapy versus bevacizumab plus chemotherapy in patients with first-line unresectable metastatic colorectal cancer. The primary endpoint for this study is progression-free survival.
Like HARMONi-GI3, Summit plans to initiate more late-stage studies on ivonescimab. It intends to provide more details in the first quarter of 2026.
Summit Therapeutics’ Zacks Rank & Stocks to Consider
Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have declined 2.6% over the past year.
Assertio’s earnings beat estimates in one quarter, and missed in the remaining quarters, with the negative average surprise being 35.21%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have risen 10.7% over the past year.
Alkermes’ earnings beat estimates in three of the trailing four quarters, and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Soleno Therapeutics’ 2026 earnings per share have increased from $3.48 to $3.87. SLNO shares have declined 19.3% over the past year.
Soleno Therapeutics’ earnings beat estimates in three of the trailing four quarters, and missed in the remaining one, with the average negative earnings surprise being 0.63%.
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FDA Accepts SMMT's Application Seeking Approval for NSCLC Drug
Key Takeaways
Summit Therapeutics (SMMT - Free Report) announced that the FDA has accepted its biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with third-generation EGFR-TKIs.
The regulatory body has set a target action date of Nov. 14, 2026.
The FDA plans to conduct a comprehensive review of the application, including mid-cycle and late-cycle meetings. If no major issues arise, labeling discussions may take place prior to the PDUFA action date.
Over the past year, shares of Summit have declined 28.4% compared with the industry’s 1.3% fall.
Image Source: Zacks Investment Research
The BLA submission was based on data from the phase III HARMONi study evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC post EGFR-TKI therapy.
The study met one of its two primary endpoints — progression-free survival. Although the study did not meet the overall survival (OS) endpoint, which the FDA had previously identified as a key requirement for filing, the data showed a favorable trend toward OS.
More on SMMT’s Ivonescimab
Ivonescimab is a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. The candidate is being developed in collaboration with China-based Akeso. The company licensed ivonescimab from Akeso in January 2023. Summit is currently conducting three late-stage studies, HARMONi, HARMONi-3, and HARMONi-7, to evaluate ivonescimab in separate settings for NSCLC indication.
Ivonescimab was earlier granted Fast Track designation by the FDA for the HARMONi study.
Additionally, SMMT expanded the development of ivonescimab beyond NSCLC by initiating enrollment in a separate phase III HARMONi-GI3 study in late 2025. The study will evaluate the drug in combination with chemotherapy versus bevacizumab plus chemotherapy in patients with first-line unresectable metastatic colorectal cancer. The primary endpoint for this study is progression-free survival.
Like HARMONi-GI3, Summit plans to initiate more late-stage studies on ivonescimab. It intends to provide more details in the first quarter of 2026.
Summit Therapeutics’ Zacks Rank & Stocks to Consider
SMMT currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Assertio Holdings (ASRT - Free Report) , Alkermes (ALKS - Free Report) and Soleno Therapeutics (SLNO - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have declined 2.6% over the past year.
Assertio’s earnings beat estimates in one quarter, and missed in the remaining quarters, with the negative average surprise being 35.21%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have risen 10.7% over the past year.
Alkermes’ earnings beat estimates in three of the trailing four quarters, and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Soleno Therapeutics’ 2026 earnings per share have increased from $3.48 to $3.87. SLNO shares have declined 19.3% over the past year.
Soleno Therapeutics’ earnings beat estimates in three of the trailing four quarters, and missed in the remaining one, with the average negative earnings surprise being 0.63%.