Summit Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA Seeking Approval for Ivonescimab in Combination with Chemotherapy in 2L+ Treatment of Patients w...
Summit Therapeutics Inc. (SMMT)
Last summit therapeutics inc. earnings: 6/12 07:00 am
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Source: Business Wire
Significant Unmet Need Remains in this SettingOver 14,000 Patients are Eligible for 2L+ Treatment in This Setting in the United States Each YearSummit Enters 2026 with Approximately $710 Million in Cash MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for ivonescimab, the novel, first-in-class investigational bispecific antibody, in combination with chemotherapy in second-line or later treatment of patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The BLA submission was based on the overall results of the global Phase III HARMONi trial. The BLA was submitted during the fourth quarter of 2025.“This BLA submission, the first for ivonescimab, marks a critical milestone for Summit, our global clinical develop
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News
- Summit Therapeutics (NASDAQ:SMMT) was given a new $40.00 price target on by analysts at Piper Sandler.MarketBeat
- Summit Therapeutics (NASDAQ:SMMT) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Is Summit Therapeutics (SMMT) Still Attractive After Recent Pullback And Multi Year Surge [Yahoo! Finance]Yahoo! Finance
- Summit Therapeutics (SMMT) Is Down 8.7% After Ivonescimab BLA Filing And Oncology Expansion Update – Has The Bull Case Changed? [Yahoo! Finance]Yahoo! Finance
- 2 Biotech Stocks That Could Soar This Year [Yahoo! Finance]Yahoo! Finance
SMMT
Earnings
- 10/20/25 - Beat
SMMT
Sec Filings
- 1/12/26 - Form 4
- 1/12/26 - Form 8-K
- 1/6/26 - Form 4
- SMMT's page on the SEC website