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JERSEY CITY, N.J. - The American Academy of Dermatology (AAD) has issued a strong recommendation for VTAMA (tapinarof) cream, 1%, in the treatment of moderate to severe atopic dermatitis in adults, according to a statement from Organon (NYSE:OGN). The pharmaceutical company, currently valued at $2.59 billion, maintains a strong financial position with a healthy gross profit margin of 57.18% and revenues of $6.29 billion in the last twelve months.
The recommendation appears in the AAD’s 2025 focused guideline update for managing atopic dermatitis, the most common form of eczema, which affects approximately 26 million Americans.
VTAMA cream, a steroid-free topical aryl hydrocarbon receptor agonist, received FDA approval in December 2024 for treating atopic dermatitis in adults and pediatric patients 2 years and older. It was previously approved in May 2022 for plaque psoriasis in adults.
"With 6.6 million adults in the US living with moderate to severe AD, innovative treatment options that meet the highest standards for efficacy, safety, and tolerability are necessary," said Juan Camilo Arjona Ferreira, Head of Research and Development and Chief Medical Officer at Organon.
The recommendation is based on evidence from the ADORING 1 and ADORING 2 clinical trials. According to the company, VTAMA cream has no label warnings, precautions, contraindications, or restrictions on duration of use or body surface area affected.
In atopic dermatitis trials, the most common adverse reactions (incidence ≥1%) included upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
The AAD’s focused update incorporates recently FDA-approved therapies into existing guidance to ensure dermatologists have access to current evidence-based information.
Organon noted that findings from the Phase 3 ADORING 3 48-week extension study showed the possibility of a treatment-free interval averaging 80 days after treatment success. Trading at a P/E ratio of just 3.46, InvestingPro analysis indicates that Organon is currently undervalued, with additional insights available in the comprehensive Pro Research Report, which covers over 1,400 US stocks.
In other recent news, Organon & Co. reported mixed financial results for the first quarter of 2025. The company announced earnings per share of $1.02, surpassing analyst expectations of $0.91, but its revenue of $1.51 billion fell short of the projected $1.55 billion. Organon has decided to discontinue the development of its endometriosis pain treatment, OG-6219, following unsuccessful trial results. The trial revealed that the drug did not significantly alleviate endometriosis-related pelvic pain compared to a placebo. Additionally, the U.S. Food and Drug Administration approved HADLIMA, a biosimilar to Humira, as interchangeable, potentially offering cost savings to patients. BNP Paribas Exane recently adjusted its outlook on Organon, lowering the price target to $16 but maintaining an Outperform rating. This comes after Organon announced a larger-than-expected dividend cut to focus on debt reduction. These developments highlight Organon’s ongoing strategic adjustments and focus on women’s health and biosimilars.
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