OGN

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Retrieved on: 
Monday, April 8, 2024
Research, Women, Clinical Trials, Biotechnology, Managed Care, General Health, Pharmaceutical, Consumer, Health, Science, Name, Patient, Denosumab, BMD, Woman, Biosimilar, European, Fracture, Osteoporosis, Safety, Multimedia, OGN

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.

Key Points: 
  • 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.
  • The primary endpoints of this study were met.

Organon To Report First Quarter 2024 Results and Host Conference Call on May 2, 2024

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Women, Consumer, Health, Pharmaceutical, GAAP, Denosumab, ID, Webcast, IPR, Uncertainty, Research, Biosimilar, EDT, OGN, Broadcasting

Organon (NYSE: OGN), 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.

Key Points: 
  • Organon (NYSE: OGN), 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.
  • Organon currently expects that it will record approximately $15 million of milestone payments in the first quarter of 2024, representing approximately $0.05 to both GAAP and non-GAAP earnings per share.
  • Organon’s first quarter 2024 results have not been finalized and are subject to the company’s quarterly financial statement closing procedures.
  • Accessing First Quarter 2024 Financial Results Webcast:
    Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .

Fingerlabs Exclusively Premieres 'Begins Youth', a Derivative Drama Based on BTS' 'Hwa Yang Yeon Hwa', through Xclusive

Retrieved on: 
Tuesday, April 2, 2024
Ethereum, Bybit, Attention, Digital, KOSDAQ, Light, OTT, Chorokbaem Media, Mantle, BTS, Sale, JTBC, HYBE, Web 3.0, IP, Security token, FSN, Multimedia, IPS, OGN, Mobile phone

'Begins Youth', co-produced by Chorokbaem Media and HYBE, is a derivative drama that reconfigures the 'Hwa Yang Yeon Hwa' story previously explored through BTS' albums, music videos, and other official content since 2015.

Key Points: 
  • 'Begins Youth', co-produced by Chorokbaem Media and HYBE, is a derivative drama that reconfigures the 'Hwa Yang Yeon Hwa' story previously explored through BTS' albums, music videos, and other official content since 2015.
  • This derivative drama, inspired by BTS 'Hwa Yang Yeon Hwa', combines fiction with the group's established story.
  • The premiere trailer for 'Begins Youth' was unveiled in Paris, France, in May of the previous year, attracting considerable attention.
  • This innovative approach is exclusively facilitated through Xclusive, developed on the Mantle Network — an Ethereum Layer 2 network associated with the global cryptocurrency exchange 'Bybit'.

Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary

Retrieved on: 
Tuesday, February 20, 2024
FDA, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Certification, Sepsis, Psoriasis, Adolescence, Infection, Adalimumab, Hospital, Intuition, Public sector, TB, Risk, Safety, Arthritis, Rheumatoid arthritis, Hidradenitis suppurativa, Death, Autoimmunity, Patient, Lymphoma, Tuberculosis, Malignancy, TNF, OGN, Pharmaceutical industry

Organon (NYSE: OGN), 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.

Key Points: 
  • Organon (NYSE: OGN), 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.
  • "America’s veterans deserve access to quality medicines at a lower cost.
  • “We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the US on its formulary."
  • HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy.

Organon To Report Fourth Quarter and Full Year Results and Host Conference Call on February 15, 2024

Retrieved on: 
Thursday, February 1, 2024
Women, Biotechnology, Pharmaceutical, Managed Care, General Health, Health, Consumer, Other Health, OGN, EST, Interest, Webcast, ID

Organon (NYSE: OGN), 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.

Key Points: 
  • Organon (NYSE: OGN), 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.
  • Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .
  • A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website.
  • Pre-registration will allow participants to bypass an operator and be placed directly into the call.

Organon’s XACIATO™ (clindamycin phosphate) Vaginal Gel 2% Available Nationwide to Treat Bacterial Vaginosis (BV) in Females Aged 12 and Older

Retrieved on: 
Wednesday, January 10, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, CDAD, Development, Woman, Hydrogen chloride, Hypersensitivity, Patient, OGN, Frustration, Thermoregulation, Gynaecology, History, Bacterial vaginosis, Clostridioides, Environment, Recurrence, Research and development, BV, Bacteria, Clindamycin, Lincomycin, Infection, American College

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).
  • Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Information about XACIATO, and the eVoucher instant savings coupon for eligible patients, can be found at XACIATO.com .

Organon affirms 2023 revenue and Adjusted EBITDA guidance and provides 2024 outlook

Retrieved on: 
Monday, January 8, 2024
Biotechnology, General Health, Vitamins, Supplements, Health, Pharmaceutical, OGN, Bank statement, Acquisition, Conference, Update, Adjustment

Organon (NYSE: OGN) today affirmed prior revenue and Adjusted EBITDA guidance, indicated that free cash flow before one-time spin-related costs is expected to be above the high end of the previous guidance range, and provided high-level financial objectives for 2024.

Key Points: 
  • Organon (NYSE: OGN) today affirmed prior revenue and Adjusted EBITDA guidance, indicated that free cash flow before one-time spin-related costs is expected to be above the high end of the previous guidance range, and provided high-level financial objectives for 2024.
  • Updates to 2023 Financial Guidance Previously Provided on November 2, 2023
    For full year 2023, the company is affirming prior revenue and Adjusted EBITDA margin guidance in the ranges of $6.15 billion to $6.25 billion and 30.5% to 31.5%, respectively.
  • Organon will report its full year 2023 results and more fulsome 2024 outlook on February 15, 2024.
  • For full year 2024, Organon expects constant currency revenue growth in the low-single-digit range and stable to improving Adjusted EBITDA margin, which it expects to achieve, in part, through operating expense management.

Organon To Present at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, December 21, 2023
Biotechnology, Women, Consumer, Health, Pharmaceutical, Conference, OGN

Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9th, 2024, at 1:30 p.m. PT.

Key Points: 
  • Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9th, 2024, at 1:30 p.m. PT.
  • Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at: https://jpmorgan.metameetings.net/events/healthcare24/sessions/49500-org...

Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines

Retrieved on: 
Monday, December 18, 2023
Health, Other Consumer, Consumer, Women, Other Health, Pharmaceutical, Biotechnology, Galcanezumab, Sale, Norton Lilly International, Vomiting, Woman, Migraine, NYSE, Headache, Disease, Patient, Light, OGN, Eli Lilly and Company, Nausea, Disability, Central nervous system, CGRP, Education, Pharmaceutical industry, Lilly, Organon

RAYVOW is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.

Key Points: 
  • RAYVOW is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.
  • “This commercialization agreement aligns seamlessly with Organon’s suite of central nervous system treatments in our Established Brands portfolio and, most importantly, it further bolsters our offerings to women, who are disproportionately impacted by migraine,” said Kevin Ali, Organon CEO.
  • “We are confident this collaboration with Organon will help even more people throughout Europe gain access to our innovative migraine treatments.”
    Under the terms of the agreement, Organon will become the sole distributor and promoter of Emgality and RAYVOW in Europe.
  • Total consideration to be paid to Lilly includes an upfront payment of $50 million and sales-based milestone payments.

Organon To Present at the Piper Sandler 35th Annual Healthcare Conference

Retrieved on: 
Tuesday, November 21, 2023
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, EST, OGN, NYSE, Conference, Piper Sandler Companies, Pharmaceutical industry, Organon

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Wednesday, November 29, 2023 at 11:00 a.m. EST.