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Organon Wins FDA Nod to Expand TOFIDENCE Use in Severe CRS & COVID-19
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Key Takeaways
OGN's TOFIDENCE gained FDA approval for severe CRS and certain hospitalized COVID-19 patients.
Organon shares rose 0.5% after the news and have surged 87.6% YTD.
TOFIDENCE's expanded use supports Organon's biosimilars portfolio and access push.
Organon & Co. (OGN - Free Report) recently announced that the FDA has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi), expanding the drug’s indications to include severe or life-threatening cytokine release syndrome (CRS) and certain hospitalized COVID-19 patients. TOFIDENCE is a biosimilar to ACTEMRA (tocilizumab) and was the first approved tocilizumab biosimilar in the United States.
Per management, the expanded indications for TOFIDENCE mark an important step in improving access to treatments for critical conditions, including CRS, a serious side effect of CAR-T therapies. Broader use of TOFIDENCE supports OGN’s commitment to expanding access to high-quality, affordable treatment options while strengthening its biosimilar portfolio.
OGN Stock’s Trend Following the News
Shares of Organon have gained 0.5% since the announcement on Wednesday. In the year-to-date (YTD) period, the stock surged 87.6%, outperforming the industry’s 7.4% decline and the S&P 500’s 6.3% rise.
The expanded indications broaden its addressable patient population and are likely to strengthen TOFIDENCE’s market position. CRS is a serious complication associated with CAR-T cell therapies, and the addition of this indication enhances the drug’s relevance in oncology-related supportive care. The COVID-19 indication further expands TOFIDENCE’s utility in hospital settings, creating additional growth opportunities for Organon’s biosimilar business.
OGN currently has a market capitalization of $3.51 billion.
Image Source: Zacks Investment Research
More on TOFIDENCE’s Expanded Role
Launched in May 2024, TOFIDENCE is currently approved for several inflammatory and autoimmune conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. The latest FDA approval broadens its clinical reach into critical-care settings.
The approval allows TOFIDENCE to be used in adults and pediatric patients aged two years and older with CAR T cell-induced severe or life-threatening CRS. It is also approved for hospitalized COVID-19 patients receiving systemic corticosteroids who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Although patients receiving tocilizumab products should be monitored for serious infections, the new indications underscore TOFIDENCE’s growing importance as a cost-effective treatment option, reinforcing Organon’s commitment to expanding access to high-quality healthcare solutions.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the biosimilars market is valued at $47.36 billion in 2026 and is expected to witness a CAGR of 16.84% through 2035.
Factors like the rising prevalence of diseases and the effective treatment of these chronic diseases at affordable costs are the two major drivers of the biosimilars market.
Other News
In April, Organon entered into an agreement to be acquired by Sun Pharmaceutical Industries Ltd. in an all-cash transaction valued at $11.75 billion, with Sun Pharma offering $14.00 per share. The offer represents a 103% premium to Organon’s closing share price on April 9, 2026. The transaction, approved by the boards of both companies, is expected to close in early 2027. The acquisition is expected to strengthen Sun Pharma’s global presence by leveraging Organon’s portfolio, international footprint and stakeholder relationships.
Organon and Shanghai Henlius Biotech announced that the European Commission had granted marketing authorization for POHERDY (pertuzumab). It is the first and only biosimilar to PERJETA approved in Europe for the treatment of certain HER2-positive breast cancers.
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently sporting a Zacks Rank #1, reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2 (Buy), reported a first-quarter 2026 adjusted loss per share of 81 cents, which came narrower than the Zacks Consensus Estimate by 35.71%. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, with the average surprise being 25.6%.
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Organon Wins FDA Nod to Expand TOFIDENCE Use in Severe CRS & COVID-19
Key Takeaways
Organon & Co. (OGN - Free Report) recently announced that the FDA has approved a supplemental Biologics License Application (sBLA) for TOFIDENCE (tocilizumab-bavi), expanding the drug’s indications to include severe or life-threatening cytokine release syndrome (CRS) and certain hospitalized COVID-19 patients. TOFIDENCE is a biosimilar to ACTEMRA (tocilizumab) and was the first approved tocilizumab biosimilar in the United States.
Per management, the expanded indications for TOFIDENCE mark an important step in improving access to treatments for critical conditions, including CRS, a serious side effect of CAR-T therapies. Broader use of TOFIDENCE supports OGN’s commitment to expanding access to high-quality, affordable treatment options while strengthening its biosimilar portfolio.
OGN Stock’s Trend Following the News
Shares of Organon have gained 0.5% since the announcement on Wednesday. In the year-to-date (YTD) period, the stock surged 87.6%, outperforming the industry’s 7.4% decline and the S&P 500’s 6.3% rise.
The expanded indications broaden its addressable patient population and are likely to strengthen TOFIDENCE’s market position. CRS is a serious complication associated with CAR-T cell therapies, and the addition of this indication enhances the drug’s relevance in oncology-related supportive care. The COVID-19 indication further expands TOFIDENCE’s utility in hospital settings, creating additional growth opportunities for Organon’s biosimilar business.
OGN currently has a market capitalization of $3.51 billion.
Image Source: Zacks Investment Research
More on TOFIDENCE’s Expanded Role
Launched in May 2024, TOFIDENCE is currently approved for several inflammatory and autoimmune conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. The latest FDA approval broadens its clinical reach into critical-care settings.
The approval allows TOFIDENCE to be used in adults and pediatric patients aged two years and older with CAR T cell-induced severe or life-threatening CRS. It is also approved for hospitalized COVID-19 patients receiving systemic corticosteroids who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Although patients receiving tocilizumab products should be monitored for serious infections, the new indications underscore TOFIDENCE’s growing importance as a cost-effective treatment option, reinforcing Organon’s commitment to expanding access to high-quality healthcare solutions.
Industry Prospects Favoring the Market
Going by data provided by Precedence Research, the biosimilars market is valued at $47.36 billion in 2026 and is expected to witness a CAGR of 16.84% through 2035.
Factors like the rising prevalence of diseases and the effective treatment of these chronic diseases at affordable costs are the two major drivers of the biosimilars market.
Other News
In April, Organon entered into an agreement to be acquired by Sun Pharmaceutical Industries Ltd. in an all-cash transaction valued at $11.75 billion, with Sun Pharma offering $14.00 per share. The offer represents a 103% premium to Organon’s closing share price on April 9, 2026. The transaction, approved by the boards of both companies, is expected to close in early 2027. The acquisition is expected to strengthen Sun Pharma’s global presence by leveraging Organon’s portfolio, international footprint and stakeholder relationships.
Organon and Shanghai Henlius Biotech announced that the European Commission had granted marketing authorization for POHERDY (pertuzumab). It is the first and only biosimilar to PERJETA approved in Europe for the treatment of certain HER2-positive breast cancers.
Organon & Co. Price
Organon & Co. price | Organon & Co. Quote
OGN’s Zacks Rank & Stocks to Consider
Currently, OGN carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are West Pharmaceutical (WST - Free Report) , Globus Medical (GMED - Free Report) and Biodesix (BDSX - Free Report) .
West Pharmaceutical, sporting a Zacks Rank #1 (Strong Buy) at present, reported first-quarter 2026 earnings per share (EPS) of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 19.4%.
Globus Medical, currently sporting a Zacks Rank #1, reported first-quarter 2026 adjusted EPS of $1.12, which surpassed the Zacks Consensus Estimate by 22.1%. Revenues of $759.9 million beat the Zacks Consensus Estimate by 4.0%.
Globus Medical has an estimated long-term earnings growth rate of 10.2%. GMED’s earnings beat estimates in each of the trailing four quarters, the average surprise being 26.3%.
Biodesix, currently carrying a Zacks Rank of 2 (Buy), reported a first-quarter 2026 adjusted loss per share of 81 cents, which came narrower than the Zacks Consensus Estimate by 35.71%. Revenues of $26 million beat the Zacks Consensus Estimate by 12.3%.
BDSX has an estimated earnings growth rate of 36% for 2026. The company beat earnings estimates in three of the trailing four quarters and missed once, with the average surprise being 25.6%.