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On Monday, H.C. Wainwright initiated coverage on Agios Pharmaceuticals (NASDAQ:AGIO), assigning a Buy rating to the company’s stock along with a price target of $58.00. The target represents significant upside potential from the current price of $35.22, with analyst targets ranging from $45 to $74. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics. The firm’s analyst, Emily Bodnar, expressed optimism about Agios’s lead asset, mitapivat (Pyrukynd), a pyruvate kinase (PK) activator. Mitapivat has already received FDA approval in February 2022 for the treatment of adult PK deficiency (PKD). With a market capitalization of $2 billion and strong financial health indicators, including more cash than debt on its balance sheet, the company appears well-positioned to execute its commercialization strategy. Discover more insights about AGIO’s financial strength with a InvestingPro subscription, which includes exclusive ProTips and comprehensive analysis.
Mitapivat works by activating the PK pathway in cells, which helps to increase adenosine triphosphate (ATP) production and reduce 2,3-diphosphoglycerate (2,3-DPG) levels. This process is crucial for converting glucose into lactic acid in various cell types, and PK dysfunction is associated with several hereditary hemolytic anemias, including PKD, thalassemia (thal), sickle cell disease (SCD), and low-risk myelodysplastic syndromes (LR-MDS).
Despite PKD being an ultra-rare disease with an estimated 3,000-8,000 patients in the US and EU5, H.C. Wainwright sees mitapivat as having the potential for label expansion into two larger patient populations by 2026. The analyst anticipates new approved indications for thalassemia, affecting an estimated 18-23 thousand patients, and SCD, impacting around 120-135 thousand patients in the US and EU5.
The analyst points out that mitapivat’s established recognition among hematologists due to its PKD approval could lead to a successful commercial launch in thalassemia, with a PDUFA date set by September 7, 2025. The potential for a later expansion into SCD in the second half of 2026 is also noted, as the same physicians typically treat all three conditions. The company’s revenue has shown strong growth of 36% in the last twelve months, though InvestingPro data indicates analysts expect challenging near-term profitability. Access the full Pro Research Report for detailed analysis of AGIO’s growth prospects and financial outlook.
Mitapivat is currently the only therapy in development for thalassemia that has demonstrated efficacy across all subtypes, including alpha and beta thalassemia, transfusion-dependent, and non-transfusion-dependent patients. This breadth of efficacy suggests a broad treatment approach and ease of use for hematologists.
The RISE UP study’s Phase 2 data in SCD have shown promising results, with significant increases in hemoglobin levels and reductions in vaso-occlusive crises (VOCs), which the analyst believes to be superior to competing treatments. Confidence is expressed in the forthcoming Phase 3 data from the RISE UP study, expected in late 2025, with the potential for approval in three indications by the end of 2026.
In other recent news, Agios Pharmaceuticals reported its fourth-quarter 2024 earnings, surpassing analysts’ expectations. The company achieved an earnings per share (EPS) of -$1.44, which was better than the forecasted -$1.68, and reported revenue of $10.7 million, exceeding the projected $9.32 million. Agios also noted a significant 51% year-over-year increase in net Pyrakind revenue. The company ended the quarter with a strong cash position, holding $1.5 billion in cash, cash equivalents, and marketable securities.
Agios Pharmaceuticals is preparing for a potential approval and launch of its product Pyrakind for thalassemia in September 2025. The company is also advancing its pipeline with ongoing trials and regulatory filings, including a Phase III study for sickle cell disease expected to report results by the end of 2025. CEO Brian Goff has expressed confidence in 2025 being a pivotal year for Agios, with plans to maximize the Pyrakind franchise and advance pipeline programs.
The company is strategically focusing on capital deployment to support its growth, backed by a solid balance sheet. Agios is also addressing operational risks, such as scaling up its sales force for the upcoming thalassemia launch. The company is awaiting a regulatory decision from the FDA on thalassemia by September 2025 and is actively engaging with analysts and investors about its progress and future plans.
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