Shares of Organon & Co (NYSE: OGN) soared 6.26% in the past 24 hours following an update on the U.S. Food and Drug Administration's (FDA) review process for the company's investigational drug VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis (AD) in adults and children aged two and above.

The FDA has extended the target action date for reviewing the supplemental New Drug Application (sNDA) for VTAMA by three months, from December 12, 2024, to March 12, 2025. This extension was triggered by the agency's request for additional data from the long-term extension study for VTAMA, which constituted a major amendment to the sNDA.

While the delay could be seen as a setback, Organon remains optimistic about VTAMA's prospects. "Organon remains confident in the robust efficacy and safety data package that has been submitted to the agency to support the review of VTAMA for AD," said Juan Camilo Arjona Ferreira, MD, Head of Research & Development at Organon.