Agios reported a net loss of $103.4 million for the quarter ended September 30, 2025, compared with a net income of $947.9 million in the same quarter of 2024. The swing is largely attributable to the absence of the milestone payment from Servier and the sale of royalty rights to Royalty Pharma that drove the prior year’s income. The company’s earnings per share were –$1.78, better than the consensus estimate of –$1.90.
Revenue for the quarter was $12.9 million, a 44% increase from $9.0 million in Q3 2024 and a 3% rise from $12.5 million in Q2 2025. PYRUKYND net revenue accounted for $12.9 million, reflecting strong commercial performance in the thalassemia and sickle cell disease markets. Research and development expenses rose to $86.8 million, up $14.3 million from Q3 2024, driven by increased clinical trial costs for the PK activation franchise. Selling, general and administrative expenses increased to $41.3 million, up $2.7 million from the prior year.
The company completed enrollment in the Phase 2b tebapivat trial for lower‑risk myelodysplastic syndromes, with topline data expected in early 2026. Agios also highlighted its focus on two key PYRUKYND milestones: the potential U.S. approval in thalassemia, with a PDUFA goal date of December 7 2025, and the topline results from the RISE UP Phase 3 trial in sickle cell disease, expected by year‑end 2025.
Agios maintains a strong cash position of $1.3 billion as of September 30, 2025, providing financial independence to fund its pipeline and potential commercial launches. The company has entered into partnerships for the commercialization of PYRUKYND in Europe and the GCC region, positioning it for broader market penetration.
Management expressed confidence in the company’s growth trajectory, citing robust demand for PYRUKYND and the strategic focus on rare‑disease indications. The company reiterated its commitment to advancing its pipeline and preparing for potential U.S. commercial launches.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.