Organon updates outlook as FDA delays VTAMA label expansion
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Organon (NYSE:OGN) projected a roughly 75 basis-point headwind to the company’s 2025 EBITDA margin on Tuesday after the FDA delayed a potential label expansion for its skin disorder therapy VTAMA (tapinarof) cream.
The Merck (MRK) spinoff said that the regulator had assigned March 12, 2025, as the new target action date for the company’s supplemental New Drug Application for VTAMA after adding a standard three-month extension to the prior target action date of December 12, 2024.
The decision came after the FDA determined that new data OGN had submitted in response to a regulatory request constituted a major amendment to the sNDA.
The once-daily topical treatment already indicated in the U.S. for the autoimmune disease plaque psoriasis is currently under FDA review for those aged two years and older with atopic dermatitis, a skin condition known as eczema.
Given the new target action date, the company forecasted an approximately 75 basis point impact on its 2025 EBITDA margin next year and updated its projected 2025 revenue contribution from the drug to $125M.
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