Historically, females have been underrepresented in clinical trials, even for diseases and conditions that occur predominately in women.* Systemic changes to how we approach research are helping, such as the National Institutes of Health’s (NIH) legislation passed into law in 1993 mandating the inclusion of women and minority populations in clinical trials.** Over the four-year […]
https://www.organon.com/stories/transforming-clinical-trials-for-women/
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study ( NCT05346224 ) aimed to compare the efficacy and safety of HLX11 with reference Perjeta ® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta ® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles.
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia ® and Xgeva ® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. The randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study ( NCT05352516 ) aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia ® ) in postmenopausal women with osteoporosis at high risk for fracture. Eligible patients were randomised at a 1:1 ratio to receive subcutaneous injection of 60 mg of HLX14 or reference denosumab (Prolia ® ) every six months. The primary
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON ® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings. 1 Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m 2 ), with 38.1% of them having a BMI ≥30 kg/m 2 . “Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s
Third quarter 2025 revenue of $1.602 billion, up 1% as-reported and down 1% excluding the impact of foreign currency Third quarter 2025 diluted earnings per share of $0.61 and non-GAAP Adjusted diluted earnings per share of $1.01 Third quarter 2025 net income of $160 million and Adjusted EBITDA (non-GAAP) of $518 million, representing an Adjusted EBITDA margin of 32.3% Revenue guidance range for full year 2025 lowered to $6.200 billion to $6.250 billion; Adjusted EBITDA margin guidance lowered to ~31.0% Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2025. “I am humbled to be working alongside our talented team during this pivotal time for Organon,” said Joe Morrissey, Organon’s Interim Chief Executive Officer. “We are harnessing the company's many strengths, including a diverse portfolio that we expect will generate more than $900 million in free cash flow before one-time costs this year. We also remain committed to exercising cost discipline
https://www.organon.com/news/organon-reports-results-for-the-third-quarter-ended-september-30-2025/
SHANGHAI, China & JERSEY CITY, NJ – SEPTEMBER 19 , 2025 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS ® (denosumab) injection 60 mg/mL and BILPREVDA ® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. 1,2 “The EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis,” said Nico Van Hoecke, Head, International Commercial at Organon. 3,4 “These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon’s commitment to advancing women’s health through access to important medicines. 4 These approvals,
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS ® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA ® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. 1,2 “The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population. 3,4,5 Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women,” said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. 3,4 “This approval underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of
Second quarter 2025 revenue of $1.594 billion Second quarter 2025 diluted earnings per share of $0.56 and non-GAAP Adjusted diluted earnings per share of $1.00; GAAP diluted earnings per share includes a $46 million gain, or $0.14 per share, for early extinguishment of debt Second quarter 2025 net income of $145 million and Adjusted EBITDA (non-GAAP) of $522 million, representing an Adjusted EBITDA margin of 32.7% The company repaid $345 million of long-term debt during the quarter; on track to achieve a net debt to Adjusted EBITDA ratio of less than 4.0x by year-end Revenue guidance range for full year 2025 raised to $6.275 billion to $6.375 billion based on the company’s current views of foreign exchange; guidance range for Adjusted EBITDA margin (non-GAAP) affirmed at 31.0% to 32.0% Organon (NYSE: OGN) today announced its results for the second quarter ended June 30, 2025. “During the quarter we paid down principal on our long-term debt and began implementing meaningful cost
https://www.organon.com/news/organon-reports-results-for-the-second-quarter-ended-june-30-2025/
The American Academy of Dermatology (AAD) provides a strong evidence-based recommendation for the use of VTAMA cream in adults with moderate to severe atopic dermatitis (AD), the most common form of eczema. Recommendation reflects VTAMA cream’s proven efficacy, safety, and tolerability as a steroid-free, topical aryl hydrocarbon receptor agonist. AD impacts 26 million people in the United States, 16.5 million of which are adults. Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, today announced that VTAMA ® (tapinarof) cream, 1%, was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD). The recommendation underscores VTAMA cream as an effective, steroid-free option for daily disease management, with no label warnings or precautions, no contraindications, and no restrictions on duration of use or percentage
HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab)1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis3 An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws4 Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira ® (adalimumab). 2 These interchangeability designations follow the interchangeability
