What Happened?
Shares of medication company Viatris (NASDAQ: VTRS) jumped 3% in the morning session after it received approval from the U.S. Food and Drug Administration (FDA) for its Iron Sucrose Injection, USP, the first generic version of Venofer® Injection. The intravenous iron replacement product is used to treat iron deficiency anemia in adult and pediatric patients with chronic kidney disease. This approval marks a significant milestone, as it's the first generic version of Venofer®, a drug with annual U.S. sales of approximately $515 million. Crucially, the U.S. Food and Drug Administration (FDA) also granted Viatris a Competitive Generic Therapy (CGT) designation for two strengths of the drug. This designation provides Viatris with 180 days of market exclusivity, giving the company a significant first-mover advantage to capture market share for this complex-to-manufacture product.
After the initial pop the shares cooled down to $9.93, up 2.3% from previous close.
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What Is The Market Telling Us
Viatris’s shares are not very volatile and have only had 8 moves greater than 5% over the last year. In that context, today’s move indicates the market considers this news meaningful, although it might not be something that would fundamentally change its perception of the business.
The previous big move we wrote about was 24 days ago when the stock dropped 3.8% on the news that its experimental therapy for blepharitis, an inflammatory condition of the eyelids, failed to meet the main goal in a late-stage study. The global healthcare company announced that its Phase 3 trial for an ophthalmic ointment, pimecrolimus 0.3% (MR-139), did not achieve its primary endpoint. The study, which involved 477 patients, was designed to evaluate if the treatment led to the complete resolution of debris on the eyelids after six weeks of use. This outcome was not met, prompting the company to re-evaluate the future of the drug's development program. Viatris' Chief R&D Officer, Philippe Martin, stated that the company was considering its next steps, which could include revising an additional planned Phase 3 study for the therapy. The setback in the trial for this eye condition represents a disappointment for the company's pipeline.
Viatris is down 20.1% since the beginning of the year, and at $9.93 per share, it is trading 25.8% below its 52-week high of $13.37 from November 2024. Investors who bought $1,000 worth of Viatris’s shares 5 years ago would now be looking at an investment worth $596.45.
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