Agios Pharmaceuticals(US:AGIO) ZACKS·2025-10-31 19:21Core Insights - Agios Pharmaceuticals reported a narrower loss of $1.78 per share in Q3 2025, compared to the Zacks Consensus Estimate of a loss of $1.93, and a significant decline from earnings of $16.22 per share in the same quarter last year [1][6] - Total revenues for the third quarter reached $12.9 million, exceeding the Zacks Consensus Estimate of $10 million, and reflecting a 44% year-over-year increase [2][6] - The company's stock rose by 2.9% following the earnings report, and has increased by 31.5% year-to-date, outperforming the industry average increase of 10.6% [2] Financial Performance - Revenues were solely derived from product sales of Pyrukynd, Agios' only marketed drug, which is approved for treating hemolytic anemia in adults with pyruvate kinase deficiency [3] - Pyrukynd's sales increased by 3% sequentially, with 149 patients currently on the therapy in the U.S., marking a 5% increase from Q2 2025 [3] - Research and development expenses rose by approximately 19.7% year-over-year to $86.8 million, attributed to higher costs related to studies on the PK activation franchise [4] - Selling, general, and administrative expenses increased by 7.3% year-over-year to $41.3 million, driven by preparations for a potential approval and launch of Pyrukynd for thalassemia [7] Pipeline Developments - The FDA is expected to make a decision on Pyrukynd's thalassemia indication by December 7, 2025, following a positive opinion from the EMA [6][11] - The FDA extended the review timeline for Pyrukynd's supplemental new drug application by three months due to a request for a Risk Evaluation and Mitigation Strategy [9][10] - Agios has completed enrollment in the phase III RISE UP study for mitapivat in treating sickle cell disease, with top-line data expected by the end of 2025 [12] - The company is also developing tebapivat for myelodysplastic syndromes, with patient enrollment in a phase IIb study completed and top-line data expected in early 2026 [13]