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Organon Presents VTAMA Study Results at Pediatric Dermatology Annual Meeting

Organon will present results from a post hoc analysis of pooled data from the Phase 3 pivotal trials, ADORING 1 and ADORING 2, evaluating the efficacy and safety of VTAMA cream versus vehicle today at the 2026 Society for Pediatric Dermatology Annual Meeting in Minneapolis, Minnesota. VTAMA cream is the first and only aryl hydrocarbon receptor agonist indicated for the treatment of both atopic dermatitis in adults and pediatric patients 2 years and older and plaque psoriasis in adults. In the ADORING 1 and ADORING 2 pivotal trials, adults and children 2 years and older with moderate to severe atopic dermatitis were randomized 2:1 to VTAMA cream or vehicle once daily for 8 weeks.

Organon Completes Global Licensing Agreement with Sebela

Organon announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA, a hormone-free, copper intrauterine device. Approved by the US Food and Drug Administration on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERTTM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm. MIUDELLA is anticipated to be commercially available in late 2026.

Samsung Bioepis and Organon Expand Collaboration Agreement

Samsung Bioepis and Organon, a global healthcare company with expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to Pyzchiva, Samsung Bioepis's biosimilar referencing Stelara - ustekinumab -. Pyzchiva is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease who have had an inadequate response to either immunomodulators or one or more tumour necrosis factor-alpha antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response to either conventional therapy or a biologic or have medical contraindications to such therapies. Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis's collaboration in Canada from five to six complementary products. An estimated 1 in 140 Canadians lives with Crohn's or colitis, the two main forms of inflammatory bowel disease. Pyzchiva is expected to be launched in the market in 2026.