EU Grants Marketing Authorization for POHERDY® Biosimilar
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Should l Buy OGN?
Source: PRnewswire
- Market Authorization Milestone: The European Commission has granted marketing authorization for Shanghai Henlius Biotech's POHERDY® (pertuzumab), the first and only biosimilar approved for all indications, marking a significant advancement in expanding treatment access for HER2-positive breast cancer patients.
- Clinical Application Expansion: POHERDY is indicated for use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy, thereby enriching treatment options and addressing the urgent market demand for effective therapies.
- Strengthened Global Collaboration: The approval reinforces the partnership between Henlius and Organon, following their exclusive commercialization agreement in 2022 covering several biosimilars, excluding the Chinese market, showcasing their strategic alignment and collaborative potential in the global market.
- Innovation-Driven Growth: Henlius currently boasts over 50 early-stage innovative assets, with 70% expected to be best-in-class, and with the approval of POHERDY, the company's competitiveness in the global biopharmaceutical market will be further enhanced, supporting the implementation of its
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Analyst Views on OGN
Wall Street analysts forecast OGN stock price to fall
5 Analyst Rating
0 Buy
1 Hold
4 Sell
Strong Sell
Current: 13.260
Low
5.00
Averages
8.50
High
12.00
Current: 13.260
Low
5.00
Averages
8.50
High
12.00
About OGN
Organon & Co. is a global healthcare company. The Company is engaged in developing and delivering health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and a franchise of established medicines across a range of therapeutic areas. It has a portfolio of approximately 70 medicines and products across a range of therapeutic areas. It has a portfolio of contraception and fertility brands, including Nexplanon, NuvaRing, and Follistim AQ. Its Biosimilars portfolio spans across immunology and oncology treatments. It also has a portfolio of established brands, including brands in cardiovascular, dermatology and non-opioid pain management. It sells these products through various channels, including drug wholesalers and retailers, hospitals, government agencies and managed health care providers, such as pharmacy benefit managers and other institutions.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Internal Transaction Review: Kennedy-Wilson Holdings is being sold for $10.90 per share in cash to a consortium led by executives, with Halper Sadeh LLC possibly requesting additional information and disclosures to protect shareholder interests.
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- RE/MAX Merger Investigation: RE/MAX Holdings, Inc. is being acquired by The Real Brokerage Inc., allowing shareholders to choose between 5.152 shares of the new company or $13.80 in cash, with investigations looking into whether the Board adequately handled the transaction to protect shareholder interests.
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See More
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- Revenue Decline: The company reported revenues of $1.46 billion, a 3.3% year-over-year decrease, missing market expectations by $30 million, reflecting challenges in a competitive landscape that could hinder future growth prospects.
- Merger Impact: In light of the pending merger, Organon will not provide financial guidance or host quarterly earnings calls, a strategy that may exacerbate investor uncertainty regarding the company's future direction and performance.
- Acquisition Rumors: Sun Pharma's plan to acquire Organon for $11.75 billion has generated positive market reactions; however, the current revenue and margin pressures may affect the feasibility of the deal and investor sentiment regarding the company's stability.
See More
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- Revenue Decline: In Q1 2026, Organon reported total revenue of $1.460 billion, a 4% decrease year-over-year, and a 9% decline when excluding foreign currency effects, indicating significant competitive pressures that may affect investor confidence moving forward.
- Profitability Challenges: The net income for the first quarter was $146 million, up 68% from $87 million in the prior year, yet the adjusted diluted earnings per share fell 30% to $0.71, reflecting rising costs and weak market demand that could hinder future profitability.
- Merger Progress: Organon announced its pending merger with Sun Pharmaceutical Industries, expected to close in early 2027, which will impact the company's strategic direction and may lead to resource reallocation to adapt to the new structure.
- Sales Volatility: Women's Health product sales declined by 16%, with Nexplanon sales in the U.S. dropping 28% primarily due to decreased physician demand and uncertainty around federal funding, highlighting how shifts in market demand directly affect company performance.
See More
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- Deepening Employment Crisis: Bernstein warns that the rise of AI may lead to a reduction in high-quality jobs in India's IT sector, affecting the income and consumption capacity of 10 to 15 million employees in IT services and outsourcing, thereby threatening the foundation of national economic growth.
- Shifting Hiring Trends: Net hiring by India's top five IT companies dropped by around 7,000 in FY26, with TCS planning to hire only 25,000 fresh graduates compared to an average of 40,000 over the past three years, indicating a diminishing reliance on large-scale recruitment in the industry.
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