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Organon & Co. reports developments as a global healthcare company with portfolios in Women's Health and General Medicines, including biosimilars. Company news commonly covers operating results, product and regulatory updates, and clinical data for medicines such as VTAMA cream for atopic dermatitis and plaque psoriasis, biosimilar approvals including POHERDY, and established women's health brands and devices such as Nexplanon, Follistim, and Jada.
Updates also address capital-structure disclosures, governance matters, shareholder voting topics, and material agreements, alongside the company's commercial activity across more than 140 markets.
Organon (NYSE: OGN) opened enrollment for the MIUDELLA® (copper intrauterine system) REMS program at www.miudellarems.com, allowing healthcare providers, healthcare settings and contracted specialty pharmacies to complete required training and certification ahead of MIUDELLA’s anticipated U.S. commercial availability in late 2026.
MIUDELLA is a hormone‑free copper IUD indicated to prevent pregnancy in females of reproductive potential for up to 3 years and is available only through this restricted REMS to ensure proper insertion training. According to Organon, Phase 3 data in women aged 17–35 years (n=1397) showed a first‑year Pearl Index of 0.94 and cumulative 3‑year Pearl Index of 1.05 (about 99% effective) with ~99% placement success. The most common adverse reactions (≥5%) included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, pelvic/procedural pain, post‑procedural hemorrhage and dyspareunia. The product carries a boxed warning on risk of complications due to improper insertion and includes extensive contraindications and precautions, such as ectopic and intrauterine pregnancy risks, pelvic infection, perforation, expulsion and Wilson’s disease.
Organon (NYSE: OGN) announced that its Board of Directors declared a quarterly cash dividend of $0.02 per share on the company’s common stock. The dividend will be paid on September 10, 2026 to stockholders of record as of the close of business on August 14, 2026.
Organon (NYSE: OGN) reported a post hoc pooled analysis of Phase 3 ADORING 1 and 2 trials of VTAMA (tapinarof) cream 1% in atopic dermatitis, presented at the 2026 Society for Pediatric Dermatology meeting. The analysis evaluated once-daily VTAMA versus vehicle over 8 weeks in 813 patients aged ≥2 years with moderate to severe disease, stratified into four age groups (2–6, 7–11, 12–17, ≥18 years). VTAMA showed early responses from week 2 and consistent improvements in skin clearance (vIGA-AD) and EASI75 at week 8 across all pediatric subsets and adults, with vIGA-AD response rates up to 56.3% and EASI75 rates up to 70.2% versus markedly lower vehicle rates. Treatment-emergent adverse events, including folliculitis, headache and nasopharyngitis, were generally mild or moderate, and discontinuations due to treatment-related adverse events occurred less often with VTAMA than with vehicle.
Organon (NYSE: OGN) plans to release its second quarter 2026 financial results through its regularly scheduled Form 10‑Q filing with the SEC. On the same day, the company plans to furnish a Form 8‑K containing certain non‑GAAP financial measures and reconciliations to comparable GAAP metrics.
According to Organon, quarterly earnings calls are suspended during the pendency of the previously announced acquisition by Sun Pharmaceutical Industries Limited, announced on April 26, 2026. The company currently expects to record approximately $1 million of milestone expense for Q2 2026. These results are not yet finalized and remain subject to normal quarterly closing procedures, and actual outcomes may differ from these preliminary expectations.
Organon (NYSE:OGN) will present a new pooled Phase 3 analysis of VTAMA (tapinarof) cream, 1% in atopic dermatitis at the 2026 Society for Pediatric Dermatology Annual Meeting in Minneapolis.
The post hoc analysis reviews efficacy and safety across pediatric and adult age groups from the ADORING 1 and 2 trials.
Organon (NYSE: OGN) and Henlius announced the Canadian launch of BILDYOS 60 mg/1 mL and TUZEMTY 120 mg/1.7 mL, denosumab biosimilars to PROLIA and XGEVA, for all reference indications.
The launch expands Organon Canada’s biosimilars portfolio to eight products across five therapeutic areas, supporting broader access to cost-effective osteoporosis and oncology bone-care treatments.
Organon (NYSE: OGN) completed a global licensing agreement with Sebela Pharmaceuticals for exclusive rights to MIUDELLA, a hormone-free copper IUD. The FDA-approved device prevents pregnancy for up to three years, is 99% effective, and uses proprietary SLIMSERT technology. US commercial launch is anticipated in late 2026 under a REMS program.
Organon (NYSE:OGN) and Samsung Bioepis expanded their agreement, giving Organon exclusive rights to commercialize PYZCHIVA (ustekinumab), a biosimilar referencing STELARA, in Canada.
This amendment grows their Canadian biosimilar portfolio from five to six products, with PYZCHIVA expected to launch in 2026 across multiple immunology and dermatology indications.
Summary not available.
Organon (NYSE:OGN) will present eight new health economics and outcomes research abstracts at ISPOR 2026, held May 17-20, 2026 in Philadelphia.
Presentations cover contraception affordability, biosimilar adoption, VTAMA budget impact, and headache referral patterns across women’s health, dermatology, biosimilars, and neurology.