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Investing.com - H.C. Wainwright has reiterated a Buy rating and $56.00 price target on Agios Pharma (NASDAQ:AGIO) following a positive regulatory development in Europe. The target represents significant upside from the current price of $42.33, with InvestingPro data showing the stock has already gained over 53% in the past six months.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Pyrukynd (mitapivat) to treat adult patients with anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.
The CHMP based its decision on Phase 3 data from the ENERGIZE and ENERGIZE-T trials, which demonstrated Pyrukynd’s positive impact on hematologic markers across all genotypes and transfusion burden levels.
The European Commission is expected to make a final approval decision by early 2026, with Agios having established a commercialization partnership with Avanzanite Bioscience for distribution in European markets.
In the United States, Pyrukynd faces a PDUFA goal date of December 7, 2025, which was delayed by three months after Agios submitted a proposed Risk Evaluation and Mitigation Strategy for liver function monitoring.
In other recent news, Agios Pharmaceuticals reported a substantial 45% year-over-year increase in net revenue for the second quarter of 2025, totaling $12.5 million. This growth underscores the company’s strategic focus on expanding its product portfolio and preparing for potential new product launches, particularly in the rare disease sector. Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on Agios’ PYRUKYND for treating anemia in adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia. This recommendation marks a significant step forward for PYRUKYND, which is already approved in Europe for adults with pyruvate kinase deficiency. The European Commission is expected to make a final decision on this recommendation by early 2026. These developments reflect Agios Pharmaceuticals’ ongoing efforts to enhance its market presence and address unmet medical needs in the rare disease landscape.
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