Organon & Co. Common Stock (OGN)

Organon (NYSEOGN) today announced its results for the fourth quarter and full year ended December 31, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2024 financial results on February 13, 2025, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.

Organon (NYSEOGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13th, 2025, at 3:45 p.m. PT.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1 Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months the target action date of its review of the supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) cream, 1% as a treatment for atopic dermatitis (AD) in adults and children two years of age and older. The new target date is March 12, 2025, revised from the original target action date of December 12, 2024. The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication.

Organon (NYSEOGN) today announced its results for the third quarter ended September 30, 2024.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab).

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant NASDAQ: ROIVNASDAQROIV)

The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its third quarter 2024 financial results on October 31, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) 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.

Organon (NYSEOGN), a global healthcare company with a mission to improve the health of women throughout their lives, and Dermavant Sciences Ltd. announced today that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant NASDAQ: ROIVNASDAQROIV)

VTAMA cream is a novel, non-steroidal topical therapy approved for treatment of plaque psoriasis in adults and is under FDA review for an additional indication to treat atopic dermatitis

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, announced it has expanded its agreement with Eli Lilly and Company (Lilly) to become the sole distributor and promoter for the migraine medicine Emgality® (galcanezumab) in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. This expanded partnership builds on Organon’s role as sole distributor and promoter of Emgality in Europe since February 2024.

Organon (NYSEOGN) today announced its results for the second quarter ended June 30, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its second quarter 2024 financial results on August 6, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1

Organon (NYSEOGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), have priced an offering of $500 million of 6.750% senior secured notes due 2034 (the “Secured Notes”) and $500 million of 7.875% senior unsecured notes due 2034 (the “Unsecured Notes” and, together with the Secured Notes the “Notes”). Each series of notes will be guaranteed by each of the entities that guarantees the Companies’ existing senior secured credit facilities (the “Credit Facilities”).

Organon (NYSEOGN) (“Organon”), a global healthcare company with a focus on women’s health, announced today that it, together with Organon Foreign Debt Co-Issuer B.V., a direct wholly-owned subsidiary of Organon, as co-issuer (the “Co-Issuer” and, together with Organon, the “Companies”), plan to offer, subject to market conditions, $500 million of senior secured notes due 2034 (the “secured notes”) and $500 million of senior unsecured notes due 2034 (the “unsecured notes” and, together with the Secured Notes the “notes”). Each series of notes will be guaranteed by each of the entities that guarantees the Companies’ existing senior secured credit facilities (the “Credit Facilities”). The notes offering is expected to be a leverage-neutral transaction.

Organon (NYSEOGN) today announced its results for the first quarter ended March 31, 2024.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its first quarter 2024 financial results on May 2, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EDT.

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSEOGN) 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.

Organon (NYSEOGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary. HADLIMA is an FDA-approved biosimilar to HUMIRA for the treatment of specific autoimmune or autoinflammatory conditions such as rheumatoid arthritis, Crohn’s disease, hidradenitis suppurativa, and plaque psoriasis (see full indications below).

Organon (NYSEOGN) today announced its results for the fourth quarter and full year ended December 31, 2023.

Organon (NYSEOGN), a global healthcare company with a focus on women’s health, will release its fourth quarter and full year 2023 financial results on February 15, 2024, prior to the company’s webcast and conference call scheduled for 8:30 a.m. EST.