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Investing.com - Cantor Fitzgerald reiterated its Overweight rating on Summit Therapeutics plc (NASDAQ:SMMT) following the FDA’s approval of a competing lung cancer treatment.
The FDA on Monday approved Dato-DXd, a TROP2 ADC therapy developed by Daiichi Sankyo and AstraZeneca (NASDAQ:AZN), for second-line and beyond EGFR-mutated non-small cell lung cancer (NSCLC) patients who previously received osimertinib treatment.
This approval targets the same indication that Summit Therapeutics’ ivonescimab will seek approval for based on its HARMONi clinical trial, according to Cantor Fitzgerald.
The research firm views the FDA’s decision to approve Dato-DXd as having favorable implications for ivonescimab’s own approval prospects with the regulatory agency.
Dato-DXd received accelerated approval based on pooled analysis from two trials after the phase 3 TROPION-Lung01 trial did not meet its primary endpoint of overall survival, with the company initially withdrawing and then refiling its Biologics License Application with the additional data.
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