Merck (NYSE: MRK) stock fell during intraday trading Friday after the FDA declined to approve a lung cancer drug developed in partnership with Daiichi Sankyo.
On Wednesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) seeking accelerated approval for patritumab deruxtecan (HER3-DXd), co-developed by Daiichi Sankyo (OTC: DSKYF) (OTC: DSNKY) and Merck & Co Inc (NYSE: MRK). The application sought accelerated approval for use in adult patients with locally advanced or EGFR-mutated metastatic non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
The CRL is based on findings from an inspection of a third-party manufacturing facility and did not raise concerns regarding the efficacy or safety data submitted for patritumab deruxtecan.
Daiichi Sankyo and Merck are jointly developing patritumab deruxtecan, a first-in-class HER3-directed DXd antibody-drug conjugate (ADC). The FDA had previously granted Priority Review to the BLA for patritumab deruxtecan in December.
The BLA submission was based on primary findings from the pivotal phase 2 HERTHENA-Lung01 trial, involving 225 patients. Results from the trial showed an objective response rate (ORR) of 29.8%. The ORR included one complete response and 66 partial responses, with a median duration of response (DoR) lasting 6.4 months.
Dr. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, expressed commitment to collaborating closely with the FDA and the third-party manufacturer to address the feedback. He underscored their determination to make patritumab deruxtecan available as the first HER3-directed therapy for patients with previously treated EGFR-mutated NSCLC.
Merck (NYSE: MRK) Stock Price Action
MRK stock declined 4.64% on Friday, closing at $123.80, marking a 5.29% decrease for the week. The trading volume was 57,055,456 shares, significantly higher than the average daily volume of 8.28 million.
Salman Akhtar is a finance, stocks, and technology journalist with years of experience across various news organizations. He has contributed his expertise to outlets such as 24NewsHD, TrimFeed, The Voice Pakistan, and TheTechBasic. Salman is passionate about making complex topics accessible to a broad audience. His dedication to delivering accurate and timely information has established him as a trusted voice in the industry. Read Full Bio
