(Reuters) -The U.S. Food and Drug Administration on Tuesday extended the review of Merus’ gene-targeting cancer therapy to allow sufficient time to assess some recent information submitted by the company, sending its U.S.-listed shares down 5.4% premarket. The health agency will now decide on the treatment zenocutuzumab by Feb. 4, 2025, compared with a previous […]
Health
US FDA extends review of Merus’ gene-targeting cancer therapy
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(Reuters) -The U.S. Food and Drug Administration on Tuesday extended the review of Merus’ gene-targeting cancer therapy to allow sufficient time to assess some recent information submitted by the company, sending its U.S.-listed shares down 5.4% premarket.
The health agency will now decide on the treatment zenocutuzumab by Feb. 4, 2025, compared with a previous action date of Nov. 6 this year.
Merus said it had submitted additional data about the therapy’s manufacturing process and quality control, in response to a request from the FDA.
The FDA has not requested any additional clinical data, the company added.
Zeno represents a modest commercial opportunity for Merus and a three to four month delay would not change that, BMO Capital Markets analyst Etzer Darout said, adding that he expects sales of $411 million in 2030 from the therapy if it is approved.
Merus said that obtaining a commercial partner is an important step in bringing zeno to patients with NRG1+ cancer.
This would help the company allocate its resources to develop its other cancer therapy, petosemtamab, that is expected to generate more revenue, Darout added.
The cancer therapy zeno targets the NRG1 gene, which is associated with the formation and progression of several tumors.
Merus is seeking approval for the therapy in patients with hard-to-treat types of lung and pancreatic cancers.
(Reporting by Bhanvi Satija and Christy Santhosh in Bengaluru; Editing by Abinaya Vijayaraghavan and Shounak Dasgupta)