Agios Pharmaceuticals, Inc. (AGIO)

Several events have impacted AGIO's stock price over the past six months. The company's 10-Q filing on July 31, 2025, reported increased net product revenue but a widened net loss due to R&D investments. Q2 2025 earnings released on August 1, 2025, showed increased GAAP net product revenue but also a widened net loss. The FDA extended the PDUFA goal date for Pyrukynd's sNDA for thalassemia to December 7, 2025, due to a request for a Risk Evaluation and Mitigation Strategy (REMS). PYRUKYND received a positive opinion from the CHMP of the European Medicines Agency for adults with thalassemia on October 17, 2025. Inhibrx's breakthrough chondrosarcoma trial results on October 24, 2025, potentially led to de-prioritization of Agios Pharmaceuticals' chondrosarcoma pipelines. Agios Pharmaceuticals initiated a Phase 1 clinical trial for AG-236 on October 27, 2025. The stock price as of October 17, 2025, was $42.33 per share, a decrease from $45.66 per share on October 21, 2024. Over the past year, AGIO underperformed both the US Biotechs industry and the broader US Market, although its share price has shown stable volatility in the past three months and over the past year.

Specific details on demand seasonality for Agios Pharmaceuticals' products are not explicitly provided, but tools like Seeking Alpha and Market Chameleon offer seasonality analysis for AGIO. The company's focus on therapies for rare, genetically defined diseases and chronic conditions suggests that demand for its products may be less subject to pronounced seasonal fluctuations.

Agios Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing therapies for genetically defined diseases, particularly rare diseases in cellular metabolism, such as hemolytic anemias. Their flagship product is PYRUKYND (mitapivat), an activator of pyruvate kinase (PK) enzymes, which is approved for treating hemolytic anemias in adults with PK deficiency and is being evaluated for thalassemia and sickle cell disease. The company's pipeline includes AG-946 (tebapivat) for hemolytic anemias and myelodysplastic syndromes, AG-181 for phenylketonuria (PKU), and AG-236 for polycythemia vera.

Agios Pharmaceuticals, Inc. is headquartered in Cambridge, Massachusetts, United States. The company's operations and market reach extend beyond the U.S. to include France, Germany, Italy, Spain, and the UK, with regulatory submissions and partnerships also in the European Union, Saudi Arabia, and the United Arab Emirates.

Agios Pharmaceuticals has maintained a reputation as a pioneering leader in cellular metabolism, prioritizing patients and scientific advancements. The company is recognized for its strong commitment to innovation in rare disease treatment. The positive opinion from the European Medicines Agency's CHMP for PYRUKYND in adults with thalassemia was a notable positive event. The FDA's extension of the PDUFA goal date for Pyrukynd's sNDA for thalassemia was viewed as procedural and did not significantly harm its reputation. Overall, there is a positive sentiment surrounding the company's pipeline and its potential for market expansion.

Agios Pharmaceuticals, Inc. has significant institutional ownership, with 472 institutional owners holding 106.17% of the company's shares. Major institutional shareholders include Farallon Capital Management Llc, Vanguard Group Inc, and BlackRock, Inc. Individual and insider ownership accounts for 33.30% of the company, with Celgene European Investment Co LLC being the largest individual shareholder. There has been significant insider selling over the past three months.