Shares of Organon & Co. (OGN) plummeted by over 5% on Monday after the company announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its drug VTAMA (tapinarof) cream for the treatment of atopic dermatitis, a common inflammatory skin condition.
The FDA has set a new target action date of March 12, 2025, to complete its review of Organon's supplemental New Drug Application for VTAMA as an atopic dermatitis treatment in adults and children aged 2 years and older. This is a three-month delay from the original target action date of December 12, 2024.
According to Organon, the FDA requested the final datasets and clinical study report from a long-term extension study for VTAMA as part of its review process. After receiving the data, the agency determined that the additional information constituted a major amendment to the application, resulting in the standard three-month extension.
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