By Colin Kellaher
Organon said the Food and Drug Administration extended by three months its review of an application seeking expanded approval of the healthcare company's recently acquired skin-care cream Vtama.
Organon, which is seeking approval of Vtama as a treatment for atopic dermatitis, said the FDA set a new target action date of March 12 for a decision after requesting the final datasets and clinical-study report from a long-term extension study.
The Jersey City, N.J., company picked up Vtama as part of its acquisition of Dermavant Sciences from Roivant Sciences last month and had been expecting a green light in atopic dermatitis by the end of the year.
Organon noted that the FDA, which approved Vtama as a treatment for plaque psoriasis in 2022, hasn't raised any concerns regarding the safety and efficacy of Vtama or any concerns regarding the approvability of the new indication.
Organon said that as a result of the delay, it now expects Vtama to contribute about $125 million in revenue next year, with the Dermavant deal reducing its 2025 adjusted earnings before interest, taxes, depreciation and amortization margin by about 75 basis points.
The company previously had forecast a $150 million revenue contribution and a 50-basis-point margin headwind next year.
Shares of Organon fell 2.9% to $16.43 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 05, 2024 08:00 ET (13:00 GMT)
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