Henlius Receives EU Approval for POHERDY® Biosimilar
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Should l Buy OGN?
Source: Newsfilter
- EU Approval Milestone: Shanghai Henlius Biotech's POHERDY® (pertuzumab) has received marketing authorization from the European Commission, becoming the first and only pertuzumab biosimilar in Europe, marking a significant advancement in treatment accessibility for HER2-positive breast cancer patients.
- Significant Market Potential: POHERDY® is indicated for use in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy, addressing urgent market needs for effective treatment options and potentially increasing Henlius's market share.
- Strengthened Partnership: The exclusive commercialization agreement between Henlius and Organon covers several biosimilars globally, excluding China, highlighting their robust collaboration in the biopharmaceutical sector, which is expected to accelerate product market entry and sales.
- Innovation-Driven Growth: Henlius is committed to advancing its globalization strategy through diverse technology platforms and global R&D capabilities, aiming to achieve regulatory approvals for 10 products across over 60 countries by 2026, thereby solidifying its competitive position in the global market.
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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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- 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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- 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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