Key Takeaways The study showed Pyrukynd met its hemoglobin endpoint but missed its goal of reducing pain crises.AGIO reported mixed secondary results, with gains in hemoglobin and bilirubin but no fatigue improvement.Agios plans a regulatory filing in early 2026, citing clearer benefits in hemoglobin responders.Shares of Agios Pharmaceuticals (AGIO) tanked about 51% on Wednesday after it reported mixed top-line results from the phase III RISE UP study, which evaluated orally administered Pyrukynd (mitapivat ...

Key Takeaways Agios reported a Q3 loss of $1.78 per share, beating expectations of a loss of $1.93.AGIO's total revenues climbed 44% year over year to $12.9 million, fueled by Pyrukynd sales.The FDA decision on Pyrukynd's thalassemia indication is due on Dec. 7, as the EMA gives a positive opinion.Agios Pharmaceuticals (AGIO) incurred a loss of $1.78 per share in the third quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.93. In the year-ago quarter, the company had reported earnin ...

Core Insights - The FDA has extended the PDUFA goal date for Agios Pharmaceuticals' Pyrukynd sNDA by three months to December 7, 2025, due to a proposed REMS submission [1][2] - The REMS submission is a significant amendment but does not involve new efficacy or safety data [2] - Pyrukynd is supported by Phase 3 trial results and has received approval from the Saudi Food and Drug Authority for similar indications [3][4] Company Developments - Agios Pharmaceuticals has entered a distribution agreement with NewBridge Pharmaceuticals to enhance regulatory filings and commercialization of Pyrukynd in the GCC region [4] - Pyrukynd is approved for treating hemolytic anemia in adults with PK deficiency in the U.S. and for PK deficiency in the EU and Great Britain [4] Market Reaction - AGIO stock has decreased by 15.83%, trading at $34.18 [5]