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TD Cowen maintained its buy rating on Agios Pharmaceuticals (NASDAQ:AGIO) Monday, citing high conviction for the company’s mitapivat drug ahead of upcoming clinical trial results. Currently trading at $35.08, the stock has shown strong momentum with a positive return over the last month, according to InvestingPro data.
The firm expressed confidence that mitapivat will demonstrate a benefit in reducing vaso-occlusive crises (VOCs) in the Phase 3 RISE-UP trial for sickle cell disease (SCD), with data expected by year-end 2025. TD Cowen believes this could open approximately $4 billion in SCD sales potential.
TD Cowen highlighted that Agios shares currently trade at an enterprise value of just $500 million, which it views as undervalued given the potential of mitapivat in SCD and the company’s upcoming thalassemia opportunity. This assessment aligns with InvestingPro’s Fair Value analysis, which indicates the stock is currently undervalued. With a market capitalization of $2.06 billion and a strong financial health score rated as "GREAT," Agios faces a September 7 PDUFA date for mitapivat in thalassemia, which the firm believes could approach $1 billion in global sales.
The firm pointed to previous Phase 2 SCD data showing up to 70% VOC reduction with mitapivat, along with supporting evidence from single-arm trials and Novo’s etavopivat, which demonstrated approximately 46% VOC reduction. These results provide validation for PKR activators’ ability to deliver VOC benefits, according to TD Cowen.
TD Cowen named Agios its top small to mid-cap pick, projecting that positive Phase 3 trial results could drive "dramatic upside" of more than 100% to the stock price by the end of 2025. This optimistic outlook is supported by analyst targets reaching as high as $71, as reported by InvestingPro, which offers additional insights and 8 more key tips about AGIO in its comprehensive Pro Research Report.
In other recent news, Agios Pharmaceuticals has been at the forefront of multiple developments. The company has entered a significant commercial and distribution agreement with Avanzanite Bioscience for its drug Pyrukynd in Europe, Switzerland, and the United Kingdom (TADAWUL:4280). This partnership, structured as a revenue share agreement, aims to expand the reach of Pyrukynd, which is already approved for treating pyruvate kinase deficiency in adults. Agios is also preparing for a potential U.S. approval for Pyrukynd in thalassemia by September 2025, with similar expectations for European approval by 2026.
Analysts have provided mixed updates on Agios. H.C. Wainwright adjusted its price target for the company to $56 from $61, maintaining a Buy rating, while Scotiabank (TSX:BNS) reduced its target to $71 from $74 but kept an Outperform rating. Cantor Fitzgerald reiterated an Overweight rating, expressing confidence in Agios’s sales targets for its thalassemia treatment, projecting sales between $300 million and $500 million.
Additionally, Agios’s collaboration with Avanzanite is seen as a strategic move to enhance the availability of rare disease therapies in Europe without the need for extensive local infrastructure. The company’s focus on thalassemia and sickle cell disease treatments continues to attract investor interest, with ongoing clinical trials being closely watched. The financial community remains attentive to Agios’s progress in these areas, as these developments could significantly impact the company’s financial trajectory and market presence.
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