ANI Stock: FDA Expands ILUVIEN Drug Approval

ANI Pharmaceuticals has achieved a significant milestone with the FDA's approval to expand its ILUVIEN medication for treating chronic non-infectious uveitis of the posterior segment (NIU-PS). This regulatory win extends the drug's application beyond its existing diabetic macular edema (DME) indication. The company plans to market ILUVIEN under this broadened scope in the US this year, potentially driving substantial business growth. In Europe, the medication already holds approval for both indications across seventeen countries. To support anticipated demand, ANI has extended its supply contract with Siegfried Holding AG through 2029, while implementing manufacturing upgrades to ensure supply stability and improve patient access. The company's strong financial foundation is evidenced by its impressive 26.2% revenue growth over the past twelve months and market capitalization of $1.25 billion.

Financial Performance Bolsters Investor Outlook

Markets have responded positively to these developments, with five analysts recently raising their earnings expectations. ANI's robust liquidity position, reflected in a current ratio of 2.72 and a "GREAT" financial health rating, underscores the company's stability. In its latest quarterly report, ANI exceeded analyst projections with adjusted earnings per share of $1.63, compared to the estimated $1.45. Quarterly revenue surged 44.8% to $190.6 million. Looking ahead, the company has elevated its 2025 revenue forecast to between $756 million and $776 million. Several financial institutions have increased their price targets, including JPMorgan (to $85) and Leerink Partners (to $82), reflecting growing confidence in ANI's strategic direction and growth potential.

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Source StockWorld