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.
Entera Bio (NASDAQ: ENTX) appointed Dr. Juan Camilo Arjona Ferreira to its Board of Directors, effective December 1, 2026. He will succeed Haya Taitel, who is stepping down from the board.
Dr. Arjona Ferreira currently serves as Head of Research and Development and Chief Medical Officer at Organon. He brings more than 20 years of global clinical development experience, including previous roles at Myovant Sciences, Shionogi and Merck, with a focus on women’s health.
Organon (OGN) plans to release its third quarter 2026 financial results through its regularly scheduled Form 10-Q filing with the SEC. A Form 8-K filed the same day is planned to disclose certain non-GAAP financial measures and reconciliations to comparable GAAP measures.
Quarterly earnings calls have been suspended while the acquisition by Sun Pharmaceutical Industries, announced April 26, 2026, remains pending. Organon does not currently expect to record any milestone expense in the third quarter of 2026. Results have not been finalized and remain subject to quarterly financial statement closing procedures.
Organon (OGN) announced interim Phase 3 results evaluating its licensed hormone-free contraceptive device MIUDELLA through six years of use. Organon acquired exclusive global licensing rights from Sebela Women’s Health in June 2026. The ongoing, single-arm study reported a cumulative six-year Pearl Index—pregnancies per 100 women over one year—of 0.93 and a cumulative pregnancy rate of 3.9%. No new safety signals emerged during the additional three years. Bleeding- and pain-related discontinuations involved 139 participants (8.7%) in year one and 11 (1.9%) in year six.
The FDA accepted an application to extend use to up to six years; Organon expects agency action in the second quarter of 2027. Current approval covers up to three years. Sebela will present the results on October 17, 2026, at the Society of Family Planning Annual Meeting. Follow-up continues.
Organon (OGN) will present a real-world analysis of VTAMA cream for atopic dermatitis at the 2026 Fall Clinical Dermatology Conference.
The conference will take place in Las Vegas, Nevada. The analysis, titled Real World Effectiveness of Tapinarof 1% Cream for Atopic Dermatitis, evaluates effectiveness in patients treated with VTAMA. It covers physician-reported measures, including body surface area affected and a physician’s overall assessment, as well as patient-reported itch scores.
Organon (OGN) reports that the US FDA has accepted for review Sebela Women’s Health’s supplemental New Drug Application for MIUDELLA, seeking to extend the hormone-free copper intrauterine system’s approved duration of use from 3 to 6 years, with a PDUFA action date expected in the second quarter of 2027.
Organon completed an agreement in June 2026 to exclusively license global rights to MIUDELLA, which is indicated for pregnancy prevention for up to 3 years and is anticipated to be commercially available in late 2026. In Phase 3 US trials, the first‑year Pearl Index in women 17–35 years (n=1397) was 0.94 (95% CI 0.43–1.78) and the cumulative 3‑year Pearl Index was 1.05 (95% CI 0.66–1.60), corresponding to about 99% contraceptive efficacy and an overall placement success rate of approximately 99%. MIUDELLA is distributed under a REMS program requiring prescriber and site certification, and common adverse reactions (≥5%) included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic pain, and post‑procedural hemorrhage.
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.