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Investing.com - BofA Securities lowered its price target on Agios Pharma (NASDAQ:AGIO) to $51.00 from $52.00 while maintaining a Buy rating, following the company’s announcement of a regulatory delay. With the stock currently trading at $35.06, InvestingPro data shows analyst targets ranging from $37 to $57, suggesting potential upside despite recent challenges.
Agios Pharma announced an extension of its PDUFA date from September 7 to December 7, 2025, after submitting a Risk Evaluation and Mitigation Strategy (REMS) for hepatocellular injury. The company clarified that the extension was not due to new data requested by the FDA or submitted by Agios. According to InvestingPro analysis, the company maintains a "GOOD" overall financial health score, with strong liquidity ratios and more cash than debt on its balance sheet.
BofA Securities still views approval in thalassemia as likely, citing key opinion leader checks and strong data from both ENERGIZE and ENERGIZE-T trials. The firm maintains Agios as one of its top picks despite the delay.
The stock fell approximately 16% following the news, which BofA characterized as "overdone" while reiterating its Buy recommendation. The firm’s model now removes thalassemia sales from 2025 projections. Despite the recent drop, InvestingPro data reveals a strong 21.6% return over the past six months, though the company faces challenges with rapid cash burn and weak gross profit margins. For deeper insights into Agios’s financial health and growth prospects, investors can access the comprehensive Pro Research Report available on InvestingPro.
BofA slightly reduced its 2026 sales forecast to $46.5 million, a $4 million reduction from consensus, reflecting the delayed PDUFA date for the thalassemia treatment. With a current market capitalization of $2.02 billion and revenue of $40.88 million in the last twelve months, the stock trades at a premium valuation multiple, highlighting the market’s long-term growth expectations despite near-term challenges.
In other recent news, Agios Pharmaceuticals announced that the U.S. Food and Drug Administration has extended the review period for its thalassemia treatment, PYRUKYND, by three months. The new Prescription Drug User Fee Act goal date is now set for December 7, 2025, due to Agios submitting a Risk Evaluation and Mitigation Strategy to address potential hepatocellular injury risks. Despite safety concerns highlighted by FDA Adverse Event Reporting System reports, TD Cowen has reiterated a Buy rating on Agios Pharmaceuticals, stating that the details of the cases do not support a link between the medication and reported patient deaths. BofA Securities also maintained a Buy rating on the stock, raising its price target from $50 to $52. Agios Pharmaceuticals addressed an analyst report concerning recent safety data for PYRUKYND, clarifying that the report referenced four patient cases, three of which had been previously reported to both Agios and the FDA. These developments come as Agios continues to navigate safety concerns and regulatory processes for its treatments.
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