Tonix Pharmaceuticals stock halted ahead of FDA approval news
PITTSBURGH - The U.S. Food and Drug Administration has approved Viatris Inc.’s (NASDAQ:VTRS) Iron Sucrose Injection, USP, the first generic version of Venofer Injection, the company announced Monday. The approval comes as Viatris, a prominent player in the pharmaceuticals industry with annual revenues of $14.1 billion, continues to expand its product portfolio. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics.
The intravenous iron replacement product treats iron deficiency anemia in adult and pediatric patients with chronic kidney disease. The medication will be available in three strengths: 50 mg/2.5mL, 100mg/5mL, and 200mg/10mL.
The FDA granted Viatris competitive generic therapy designation for the 100 mg/5 mL and 200 mg/10 mL strengths, providing eligibility for 180 days of market exclusivity. This designation is given to generic versions of medications with "inadequate generic competition" to expedite their market entry.
"The first FDA approval of a generic iron sucrose is an important advancement for patients with CKD and iron deficiency anemia," said Philippe Martin, Viatris Chief R&D Officer, in the press release.
Iron deficiency anemia is a common complication of chronic kidney disease associated with increased cardiovascular morbidity and higher mortality rates.
The reference drug, Venofer, had annual U.S. sales of approximately $515 million as of June 30, 2025, according to IQVIA data cited in the company statement. This market opportunity could significantly impact Viatris’s financial outlook, with InvestingPro data showing analysts expect net income growth this year. The company maintains a strong free cash flow yield of 15%, suggesting robust operational efficiency.
Viatris indicated the product was developed in-house and is expected to be available imminently. The company’s injectable pipeline includes other complex products across multiple therapeutic areas, including ferric carboxymaltose injection, another iron replacement product.
Common adverse reactions in adult patients include diarrhea, nausea, vomiting, headache, dizziness, and hypotension, according to the safety information provided in the announcement. For investors seeking deeper insights into Viatris’s market position and growth potential, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 US stocks, including detailed financial health scores and exclusive ProTips.
In other recent news, Viatris Inc. reported its second-quarter earnings for 2025, surpassing analyst expectations. The company achieved an earnings per share (EPS) of $0.62, compared to the forecasted $0.55. Additionally, Viatris exceeded revenue forecasts, reporting $3.57 billion against an anticipated $3.47 billion. These results indicate a positive financial performance for the period. While there were no recent mergers or acquisitions reported, the earnings results were a focal point for investors. Analyst firms have not provided any new upgrades or downgrades in this period. These developments reflect Viatris’ recent financial standing and are likely to influence investor sentiment.
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