Organon & Co.

Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting

Organon announced positive interim Phase 3 results for MIUDELLA, its hormone-free copper IUD, showing efficacy through 6 years of use with a cumulative Pearl Index of 0.93 and no new safety signals. The 6-year analysis drew on data presented at the 2026 Society of Family Planning Annual Meeting from a 42-site U.S. study conducted by Sebela Women's Health, which licensed global rights to Organon in June 2026. The FDA has accepted an sNDA for extended use up to 6 years, with a PDUFA action expected in Q2 2027, which would extend the product's label from the current 3-year indication.

•9d ago

Organon to Present New Real-World Analysis of VTAMA® (tapinarof) Cream, 1%, at the 2026 Fall Clinical Dermatology Conference

Organon will present a new real-world analysis of VTAMA (tapinarof) cream, 1% at the 2026 Fall Clinical Dermatology Conference in Las Vegas. The analysis is billed as one of the first large-scale real-world effectiveness studies of VTAMA in atopic dermatitis, covering physician-reported outcomes (BSA, PGA) and patient itch scores. This is a routine data-dissemination event supporting the commercialized product rather than a clinical or regulatory milestone; expect minimal market impact.

•24d ago

Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device

The FDA accepted for review Sebela Women's Health's supplemental New Drug Application for MIUDELLA, Organon's hormone-free copper intrauterine device, seeking to extend the approved duration of use from 3 to 6 years, with PDUFA action expected in the second quarter of 2027. Organon exclusively licensed global rights to MIUDELLA from Sebela in an agreement completed in June 2026, and the product is anticipated to be commercially available in late 2026. The filing is supported by a Phase 3 US trial in 1,904 women that showed the device to be approximately 99% effective, with a cumulative 3-year Pearl Index of 1.05. If approved, MIUDELLA would offer up to six years of hormone-free contraception; the current label carries a Boxed Warning and a REMS program restricting dispensing to certified providers and pharmacies.

•1mo ago

National Can-RISE Study to Help Close Critical Gaps in Menopause Research

Organon is supporting the launch of the national Can-RISE Study through a charitable grant, aimed at closing critical research gaps regarding menopause in Canada. The investigator-led study will collect data on menopause experiences to produce a report in early 2027, intended to inform healthcare policy and workplace support. This initiative aligns with Organon's focus on women's health, assisting in knowledge mobilization efforts to reach healthcare professionals and policymakers.

•1mo ago

Persistent unmet need in women's reproductive health across APAC highlights need for cross-sector partnerships

Organon announced a strategic partnership with Family Planning 2030 (FP2030) to address unmet needs in women's reproductive health across the Asia Pacific region. The collaboration aims to expand access to voluntary, rights-based family planning services and mobilize private-sector leadership through high-impact convenings. This effort leverages Organon's Her Health Grants and FP2030's convening power to unlock innovative financing and strengthen regional dialogue on gender equity and economic growth.

•2mo ago

Organon Opens REMS Program for MIUDELLA® Ahead of Anticipated Commercial Availability

Organon opened the REMS program for MIUDELLA, its hormone-free copper intrauterine device, allowing healthcare providers and pharmacies to complete required training and certification ahead of the product's late 2026 commercial launch. The REMS program mandates separate certifications for individual healthcare providers and their practice settings to mitigate risks associated with improper insertion. Clinical data from 1,904 women demonstrated 99% contraceptive efficacy and a 99% placement success rate, with discontinuation rates dropping from 8.5% in year one to 3.2% by year three.

•2mo ago

Organon Announces Quarterly Dividend

Organon’s Board of Directors declared a quarterly dividend of $0.02 per share on the company’s common stock. The dividend is payable on September 10, 2026, to stockholders of record at the close of business on August 14, 2026.

•2mo ago

New Analysis of Phase 3 Pooled Data for Organon’s VTAMA® (tapinarof) cream, 1%, Demonstrates Early, Consistent Improvements in Atopic Dermatitis Patients Across Pediatric Age Groups and in Adults1

Organon presented a post hoc analysis of Phase 3 ADORING 1 and 2 trial data showing VTAMA cream achieved early and consistent improvements in atopic dermatitis across pediatric and adult age groups. Patients aged 2-6 years demonstrated a 70.2% EASI75 response rate at week 8 compared to 20.5% for vehicle, with significant improvements observed as early as week 2 across all cohorts. Safety data remained consistent with prior studies, with folliculitis, headache, and nasopharyngitis reported as the most common treatment-emergent adverse events.

•3mo ago

OGN: 8-K · proxy statement

Organon & Co. stockholders voted overwhelmingly to approve the company's merger with Sun Pharmaceutical Holdings USA, Inc. during a special meeting held on July 23, 2026. The proposal to adopt the Merger Agreement received 192,776,552 votes in favor, compared to just 2,573,118 against, representing a strong mandate for the transaction to proceed. This approval, along with the passage of a related advisory executive compensation proposal, clears the way for Sun Pharma USA to acquire Organon, with the company surviving as a wholly owned subsidiary of Sun Pharma USA upon closing.

SEC 8-K•3mo ago

Organon to Present New Analysis on VTAMA® (tapinarof) cream, 1%, at the 2026 Society for Pediatric Dermatology Annual Meeting

Organon announced that a new pooled analysis of Phase 3 data for VTAMA cream will be presented at the 2026 Society for Pediatric Dermatology Annual Meeting. The analysis evaluates the efficacy and safety of VTAMA across pediatric and adult age groups using data from the pivotal ADORING 1 and ADORING 2 trials for moderate to severe atopic dermatitis. VTAMA is the only aryl hydrocarbon receptor agonist indicated for both plaque psoriasis and atopic dermatitis in adults and pediatric patients ages two and older, backed by strong recommendations from the American Academy of Dermatology.

•3mo ago

Organon Canada and Henlius Expand Access to Denosumab Treatments With Launch of BILDYOS® (denosumab injection) and TUZEMTY® (denosumab injection), Biosimilars to PROLIA and XGEVA

Organon Canada and Henlius launched BILDYOS and TUZEMTY, biosimilars to PROLIA and XGEVA, now available in Canada for osteoporosis and bone events associated with cancer. The launch expands Organon’s biosimilars portfolio in Canada to eight products spanning five therapeutic areas, leveraging products with more than nine years of market experience. Management highlighted that the addition reinforces the commitment to expanding access to cost-effective treatments and strengthening the healthcare system.

•4mo ago

Organon Completes Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device

Organon completed a global licensing agreement with Sebela Pharmaceuticals for MIUDELLA, the first hormone-free copper intrauterine device (IUD) introduced in the US in over 40 years. Approved by the FDA in February 2025, MIUDELLA is 99% effective over three years and features proprietary SLIMSERT technology designed for easier insertion. Commercial availability is anticipated in late 2026, though the product will be subject to a Risk Evaluation and Mitigation Strategy (REMS) to ensure proper provider training.

•4mo ago

Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada

Organon expanded its partnership with Samsung Bioepis to secure exclusive commercialization rights in Canada for PYZCHIVA, a biosimilar referencing STELARA. The agreement adds a sixth product to the companies' Canadian collaboration portfolio, which covers therapeutic areas including immunology and oncology. Management expects PYZCHIVA to launch in the Canadian market in 2026, aiming to expand access for patients with conditions like psoriasis and Crohn's disease.

•4mo ago

OGN: DEFM14A · proxy statement

Organon has entered into a definitive agreement to be acquired by Sun Pharmaceutical Holdings USA for $14.00 per share in cash. This represents a 103% premium to the unaffected closing price and values the transaction at approximately $3.68 billion. The special meeting of stockholders is scheduled for July 23, 2026, where a majority vote is required to approve the merger. Morgan Stanley issued a fairness opinion, and the board unanimously recommends voting in favor of the transaction. Upon completion, expected in early 2027, Organon shares will be delisted and the company will become a wholly owned subsidiary of Sun Pharma USA. A termination fee of $120 million is payable if Organon accepts a superior proposal.

SEC DEFM14A•4mo ago

Organon Secures US Food and Drug Administration Approval Expanding Indications for TOFIDENCE® (tocilizumab-bavi) in Cytokine Release Syndrome (CRS) and Pediatric COVID-19

Organon received FDA approval for two new indications for TOFIDENCE, its tocilizumab biosimilar: treatment of cytokine release syndrome (CRS) in CAR-T patients and hospitalized pediatric COVID-19 cases. TOFIDENCE, the first approved tocilizumab biosimilar in the US, launched in May 2024. Organon acquired US rights to the asset in 2025 from developer Bio-Thera Solutions. The expanded label supports Organon’s biosimilar portfolio strategy, targeting high-cost biologic markets with cost-effective alternatives for critical conditions.

•4mo ago

OGN: PREM14A · proxy statement

Organon & Co. is soliciting stockholder approval for a definitive agreement to be acquired by Sun Pharmaceutical Industries Ltd. for $14.00 per share in cash. The transaction represents a premium of approximately 103% to the unaffected closing price and 120% to the 30-day volume-weighted average price. The merger is expected to close in early 2027, subject to regulatory approvals and stockholder vote. Sun Pharma USA has secured a committed $12 billion senior secured bridge loan facility to fund the transaction, with no financing condition attached to the closing. Upon completion, Organon will become a wholly owned subsidiary of Sun Pharma USA, and its common stock will be delisted from the NYSE. A termination fee of $120 million is payable by Organon to Sun Pharma USA under certain circumstances, including a change in board recommendation or acceptance of a superior proposal.

SEC PREM14A•4mo ago

European Commission (EC) Approves Henlius and Organon's POHERDY® (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe

The European Commission granted marketing authorization for POHERDY, the first biosimilar to PERJETA, developed in partnership with Shanghai Henlius Biotech. Organon holds exclusive commercialization rights for POHERDY globally, excluding China, securing a foothold in the European market for HER2-positive breast cancer treatments. The approval covers all indications of the reference product, including neoadjuvant, adjuvant, and metastatic treatment settings.

•5mo ago