Organon Says European Medicines Agency (Ema) Validates Henlius And Organon Filings For Prolia And Xgeva (Denosumab) Biosimilar Candidate HlX14

5/24/24 6:03:07 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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Company 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

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Recent Analyst Ratings for
$OGN

Date	Price Target	Rating	Analyst
9/6/2024	$18.00 → $20.00	Neutral → Underweight	JP Morgan
11/3/2023	$33.00 → $16.00	Buy → Neutral	Goldman
9/21/2023	$28.00	Overweight	Barclays
3/16/2023	$33.00	Outperform	Raymond James
10/14/2022	$27.00 → $25.00	Neutral → Underperform	BofA Securities
9/6/2022	$37.00 → $34.00	Neutral → Overweight	Piper Sandler
8/5/2022	$40.00 → $37.00	Buy → Neutral	BofA Securities
4/27/2022	$40.00	Buy	Goldman

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Organon Reports Results for the Third Quarter Ended September 30, 2024
Third quarter 2024 revenue of $1.582 billion, up 4% as-reported and up 5% at constant currency Third quarter 2024 diluted earnings per share of $1.38 and non-GAAP Adjusted diluted earnings per share of $0.87; both reported and non-GAAP Adjusted diluted earnings per share include $51 million of expense, or $0.16 per share, for acquired in-process research and development (IPR&D) and milestones Third quarter 2024 net income of $359 million and Adjusted EBITDA (non-GAAP) of $459 million Guidance range for full year 2024 revenue narrowed to $6.375 billion to $6.425 billion, mid-point of the range raised by $50 million; Guidance range for Adjusted EBITDA margin (non-GAAP) revised to 30.0%
10/31/24 7:30:00 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
Health Care
Organon to Report Third Quarter 2024 Results and Host Conference Call on October 31, 2024
Company estimates $51 million of milestone expense in the third quarter Organon (NYSE:OGN), 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. IPR&D and Milestones Organon currently expects that it will record $51 million of milestone expense in the third quarter of 2024, representing an impact of approximately $0.16 to both GAAP and non-GAAP earnings per share. Of the anticipated milestone expense in the quarter, $50 million relates to a denosumab biosimilar candidate which is progressing under the company's license agreement
10/9/24 7:30:00 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
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Organon Reports Results for the Second Quarter Ended June 30, 2024
Second quarter 2024 revenue of $1.607 billion, flat year-over-year on an as-reported basis and up 2% at constant currency Second quarter 2024 diluted earnings per share of $0.75 and non-GAAP Adjusted diluted earnings per share of $1.12; both reported and non-GAAP Adjusted diluted earnings per share include $15 million of expense, or $0.05 per share, for acquired in-process research and development (IPR&D) and milestones Second quarter 2024 net income of $195 million and Adjusted EBITDA (non-GAAP) of $513 million Guidance range for full year 2024 revenue narrowed to $6.250 billion to $6.450 billion, mid-point of the range, affirmed; Guidance range for Adjusted EBITDA margin (non-GA
8/6/24 7:30:00 AM ET
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Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older
Organon (NYSE:OGN), 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. As part of i
11/5/24 7:29:00 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
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Organon Reports Results for the Third Quarter Ended September 30, 2024
Third quarter 2024 revenue of $1.582 billion, up 4% as-reported and up 5% at constant currency Third quarter 2024 diluted earnings per share of $1.38 and non-GAAP Adjusted diluted earnings per share of $0.87; both reported and non-GAAP Adjusted diluted earnings per share include $51 million of expense, or $0.16 per share, for acquired in-process research and development (IPR&D) and milestones Third quarter 2024 net income of $359 million and Adjusted EBITDA (non-GAAP) of $459 million Guidance range for full year 2024 revenue narrowed to $6.375 billion to $6.425 billion, mid-point of the range raised by $50 million; Guidance range for Adjusted EBITDA margin (non-GAAP) revised to 30.0%
10/31/24 7:30:00 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
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US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)
Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE:OGN) 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). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241029648679/en/ 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 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the
10/30/24 6:00:00 AM ET
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Organon Says European Medicines Agency (Ema) Validates Henlius And Organon Filings For Prolia And Xgeva (Denosumab) Biosimilar Candidate HlX14
Company 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
5/24/24 6:03:07 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
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Wall Street's Most Accurate Analysts' Views On 3 Health Care Stocks With Over 5% Dividend Yields
During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a high dividend payout. Benzinga readers can review the latest analyst takes on their favorite stocks by visiting our Analyst Stock Ratings page. Traders can sort through Benzinga's extensive database of analyst ratings, including by analyst accuracy. Below are the ratings of the most accurate analysts for three high-yielding stocks in the health care sector. Pfizer Inc. (NYSE:PFE) Dividend Yield: 5.96% Morgan Stanley analyst Terence Flynn maintained an Equal-Weight rating and increase
5/10/24 8:01:24 AM ET
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Reported Earlier, Organon Prices $1B Dual Series Senior Notes: $500M 6.750% Secured, $500M 7.875% Unsecured, Both Due 2034
The Companies intend to use the net proceeds from the sale of the Notes to repay a portion of their borrowings under the Credit Facilities' U.S. dollar-denominated "tranche B" term loan and to pay the fees and expenses incurred in connection with the foregoing
5/8/24 4:02:01 AM ET
$OGN
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Organon Canada Promotes Geneviève Gauthier as Executive Director, Corporate Affairs and Community Engagement and Appoints Jeffrey Malawski as Executive Director, Women's Health and Established Brands
Organon Canada's operations are led by a diverse and highly capable team of equally represented men and women, offering a combination of relevant skills and experience, with a mission to deliver impactful medicines and solutions for a healthier every day for everyone, with a focus on women's health. KIRKLAND, QC, Oct. 8, 2024 /CNW/ - Organon Canada, a subsidiary of Organon (NYSE:OGN), a global healthcare company with a focus on women's health, today announced updates to its Canadian leadership team with an appointment and promotion. Effective September 1, 2024, Jeffrey Malawsk
10/8/24 8:01:00 AM ET
$OGN
Biotechnology: Pharmaceutical Preparations
Health Care
On International Women's Day, Organon Canada is encouraging businesses to Invest in HER and help address gender inequities through women's health
Organon Canada launches 'HER Professional Journey' to support female employees to navigate their career paths, and announces a new commitment to funding menopause-related education KIRKLAND, QC, March 8, 2024 /CNW/ - On International Women's Day, Organon Canada, a subsidiary of Organon (NYSE:OGN), a global healthcare company with a focus on women's health, launches HER Professional Journey and is encouraging businesses in Canada to Invest in HER and address the unique health experiences that women face, including in the workplace, so that women can feel supported and empowered at every stage of their career.
3/8/24 9:01:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Lululemon Athletica & Hubbell Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600
NEW YORK, Oct. 13, 2023 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the opening of trading on Wednesday, October 18: Lululemon Athletica Inc. (NASD:LULU) will replace Activision Blizzard Inc. (NASD:ATVI) in the S&P 500. S&P 500 and S&P 100 constituent Microsoft Corp. (NASD: MSFT) acquired Activision Blizzard in a transaction completed today, October 13. S&P MidCap 400 constituent Hubbell Inc. (NYSE:HUBB) will replace Organon & Co. (NYSE:OGN) in the S&P 500, S&P SmallCap 600 constituent Onto Innovation Inc. (NYSE:ONTO) will replace Hubbell in the S&P MidCap 400, and Organon & Co will re
10/13/23 6:02:00 PM ET
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Organon Says European Medicines Agency (Ema) Validates Henlius And Organon Filings For Prolia And Xgeva (Denosumab) Biosimilar Candidate HlX14

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Weaver Kirke bought $49,939 worth of shares (2,720 units at $18.36), increasing direct ownership by 22% to 15,181 units (SEC Form 4)

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Organon downgraded by JP Morgan with a new price target

Organon downgraded by Goldman with a new price target

Barclays initiated coverage on Organon with a new price target

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SEC Form SC 13G/A filed by Organon & Co. (Amendment)

SEC Form SC 13G/A filed by Organon & Co. (Amendment)

SEC Form SC 13G/A filed by Organon & Co. (Amendment)

$OGN Financials

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Organon Reports Results for the Third Quarter Ended September 30, 2024

Organon to Report Third Quarter 2024 Results and Host Conference Call on October 31, 2024

Organon Reports Results for the Second Quarter Ended June 30, 2024

$OGN Press Releases

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Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

Organon Reports Results for the Third Quarter Ended September 30, 2024

US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)

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Head of R&D & CMO Arjona Ferreira Juan Camilo converted options into 6,446 shares and covered exercise/tax liability with 2,300 shares, increasing direct ownership by 55% to 11,687 units (SEC Form 4)

New insider Karp Daniel claimed ownership of 19,362 shares (SEC Form 3)

Chief Executive Officer Ali Kevin covered exercise/tax liability with 11,927 shares and was granted 21,567 shares, increasing direct ownership by 7% to 144,888 units (SEC Form 4)

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