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DURHAM, N.C. - Fortrea (NASDAQ:FTRE), a $461.76 million market cap clinical research organization generating annual revenues of $2.69 billion, has established a strategic collaboration with Emery Pharma to provide testing for 1-methyl-4-nitrosopiperazine (MNP) impurities in rifampin, according to a press release statement issued Tuesday. According to InvestingPro analysis, the company appears undervalued at its current price of $5.10.
The partnership aims to certify that impurity levels in rifampin remain below the Acceptable Intake Limit established by U.S. Food and Drug Administration guidelines. Rifampin is commonly used as the preferred agent in drug-drug interaction (DDI) studies due to its safety profile.
Under the agreement, Emery Pharma will perform lot-by-lot testing of rifampin using its analytical and bioanalytical capabilities, which operate under current Good Manufacturing Practice and Good Laboratory Practice standards.
"This collaboration reflects our shared commitment to smarter study design and greater participant safety," said Oren Cohen, chief medical officer and president of Clinical Pharmacology Services at Fortrea.
The testing addresses regulatory concerns that emerged in 2021 when the FDA discovered MNP, a nitrosamine impurity, in rifampin batches at levels exceeding accepted limits. In 2023, the FDA updated its guidance with revised acceptable MNP limits.
Ron Najafi, chief executive officer of Emery Pharma, said the company’s team specializes in "solving complex analytical challenges and ensuring studies meet the highest regulatory and scientific standards."
The collaboration enables Fortrea to continue offering rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies, which are essential components in the development of new therapeutics.
Fortrea provides phase I-IV clinical trial management and clinical pharmacology services across approximately 100 countries, while Emery Pharma specializes in GLP- and cGMP-compliant analytical testing from its base in Alameda, California. With strong free cash flow of $145.1 million in the last twelve months, Fortrea demonstrates robust operational efficiency. For deeper insights into Fortrea’s financial health and growth prospects, including 10+ additional ProTips, visit InvestingPro.
In other recent news, Fortrea Holdings has announced several significant developments. The company updated its executive compensation framework and elected new board members during its Annual Meeting of Stockholders. These changes include an increase in share count under the Omnibus Incentive Plan and the election of Dr. Amrit Ray, Erin L. Russell, and Machelle Sanders as Class II Directors. Additionally, Fortrea adopted a limited-duration stockholder rights plan to protect shareholder interests amid stock price volatility and third-party interest, with Barclays and Smith Anderson advising on this strategy.
In leadership news, Anshul Thakral has been appointed as the new CEO of Fortrea, effective August 4, 2025. Thakral brings over 20 years of experience in life sciences and has previously held executive roles at PPD and Launch Therapeutics. Furthermore, S&P Global Ratings downgraded Fortrea Holdings to ’B-’ due to weak credit metrics, citing high leverage and negative cash flow as concerns. Despite these challenges, the company has identified significant cost-saving opportunities and aims to achieve annual gross cost reductions of approximately $150 million.
The stable outlook from S&P Global Ratings reflects the expectation of positive free cash flow and gradual improvements in EBITDA margins. Fortrea’s efforts to optimize its business and exit transition support agreements are expected to contribute to these improvements. These recent developments underscore Fortrea’s focus on corporate governance, shareholder protection, and leadership transitions.
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