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CRYSTAL LAKE, Ill. - AptarGroup, Inc. (NYSE: ATR), a global provider of drug delivery technologies with a market capitalization of $9.5 billion and an impressive 32-year streak of consecutive dividend increases, announced today the initiation of a clinical study to validate its SmartTrack™ technology, developed by its subsidiary Nanopharm. According to InvestingPro data, the company maintains strong financial health with a "GREAT" overall rating. The study aims to demonstrate that SmartTrack™ can accurately predict clinical outcomes for generic inhaled drug products, potentially reducing the need for clinical studies in the drug approval process.
The study will involve radio-labeling three different commercially available pressurized metered-dose inhaler (pMDI) drug products to image lung deposition. These results will be compared with predictions from computational fluid dynamic (CFD) simulations and pharmacokinetic (PK) data from subjects. The PK data will validate predictions from Nanopharm’s Simhalation™ platform, which uses physiologically based pharmacokinetic (PBPK) modeling.
Expected to commence in the second quarter of 2025, the study has been designed in consultation with regulatory agencies to meet the requirements for a biowaiver of comparative clinical endpoint (CCEP) studies. With a healthy current ratio of 1.38 and moderate debt levels, AptarGroup is well-positioned to fund its research initiatives. For deeper insights into AptarGroup’s financial strength and growth potential, investors can access comprehensive analysis through InvestingPro, which offers additional ProTips and detailed metrics. The data from the study will be submitted to the U.S. FDA as part of a Model Master File (MMF), allowing multiple companies to use this data when partnering with Aptar.
Gael Touya, President of Aptar Pharma, expressed that the clinical study is a significant step in the evolution of Aptar’s offerings. The study’s results could support generic Abbreviated New Drug Application (ANDA) approvals and other programs, including reformulations and new chemical entity (NCE) development into pMDIs.
The study is slated for completion by the end of 2025, and Aptar encourages interested parties to contact Nanopharm for potential collaboration. Aptar serves various markets, including pharmaceuticals, beauty, and food and beverage, with Nanopharm specializing in services for orally inhaled and nasal drug products.
The press release contains forward-looking statements regarding the potential outcomes of the SmartTrack™ technology and is based on current beliefs and assumptions. These statements are subject to risks and uncertainties that could cause actual results to differ materially. However, analysts maintain a positive outlook on AptarGroup, with price targets ranging from $160 to $205 per share. Discover more detailed analysis and forecasts with InvestingPro’s exclusive research reports, available for over 1,400 US stocks including AptarGroup.
The information is based on a press release statement from AptarGroup, Inc.
In other recent news, AptarGroup has received an upgrade from Moody’s Ratings, which raised its long-term issuer rating to Baa2 from Baa3, citing the company’s strong profitability and conservative financial policy. Moody’s highlighted Aptar’s robust EBITDA margin of 22% in 2024, driven by its pharmaceutical packaging products, and expects this performance to continue into 2025. The company’s diversified geographic and customer base has been noted as a stabilizing factor for its profit and cash flow. S&P Global Ratings has also revised Aptar’s outlook to positive from stable, affirming its ’BBB-’ issuer credit rating, with expectations that the company’s adjusted debt to EBITDA will remain below 2x over the next 24 months. This positive outlook is supported by Aptar’s strong performance in the pharmaceutical sector and its ability to lower leverage, with a reported reduction to 1.10x by the end of 2024. Jefferies has adjusted its price target for AptarGroup to $205 from $215 while maintaining a Buy rating, following the company’s fourth-quarter earnings report that exceeded consensus estimates. Despite challenges such as foreign exchange effects and tax rate increases in France, AptarGroup is expected to achieve a 7% growth in EBITDA for 2025, driven by the introduction of new pharmaceutical products. The company’s focus on launching new products is anticipated to support an 8% compound annual growth rate through 2027.
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