Agios Receives FDA Approval for AQVESME, Potential $425K Annual Revenue
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 24 2025
0mins
Should l Buy AGIO?
Source: NASDAQ.COM
- Stock Surge: Shares of Agios Pharmaceuticals soared over 18% following FDA approval of AQVESME (mitapivat) for treating thalassemia, indicating strong market demand and a rebound in investor confidence.
- Significant Market Potential: Management noted an addressable launch population of 4,000 patients with a U.S. price of $425,000 annually, which is expected to significantly boost company revenues and enhance competitive positioning.
- Global Sales Outlook: Mitapivat has the potential to deliver $1 billion in peak-year sales across thalassemia and Pyruvate Kinase Deficiency indications, highlighting the company's strong market position and growth potential in the rare disease sector.
- Rapid Expansion Plans: This approval provides Agios with an opportunity to rapidly expand sales, especially after a previous disappointment in a sickle cell disease trial, with management expressing confidence in future market performance.
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Analyst Views on AGIO
Wall Street analysts forecast AGIO stock price to rise
9 Analyst Rating
6 Buy
3 Hold
0 Sell
Moderate Buy
Current: 28.070
Low
25.00
Averages
36.14
High
62.00
Current: 28.070
Low
25.00
Averages
36.14
High
62.00
About AGIO
Agios Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on developing and delivering transformative therapies for patients living with rare diseases. It markets a first-in-class pyruvate kinase (PK) activator for adults with PK deficiency, the first disease-modifying therapy for debilitating hemolytic anemia. Its lead product candidate in its portfolio, PYRUKYND (mitapivat), is an activator of both wild-type and mutant pyruvate kinase, or PK, enzymes for the potential treatment of hemolytic anemias. It is also developing tebapivat, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndromes, or LR MDS, and hemolytic anemias; AG-181, its phenylalanine hydroxylase, or PAH, stabilizer for the potential treatment of phenylketonuria, or PKU; and AG-236, an siRNA in-licensed from Alnylam Pharmaceuticals, Inc., targeting the transmembrane serine protease 6, or TMPRSS6 gene for the potential treatment of polycythemia vera, or PV.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Agios Pharmaceuticals Q4 2025 Earnings Call Insights
- AQVESME Launch Strategy: CEO Brian Goff emphasized that Agios will focus on executing a high-impact launch of AQVESME for thalassemia treatment in the U.S. in 2026, which is expected to enhance the company's market share and lay the groundwork for future expansions.
- PYRUKYND Revenue Growth: In Q4 2025, PYRUKYND net revenue reached $20 million, reflecting an impressive 86% year-on-year growth, indicating the effectiveness of the company's commercialization strategy in the PK deficiency market, with projected revenues of $45 million to $50 million in 2026.
- Strong Financial Position: Agios ended 2025 with approximately $1.2 billion in cash and cash equivalents, providing flexibility for the AQVESME launch and other R&D projects, showcasing the company's confidence and capability in future investments.
- Optimistic Market Outlook: Management expressed optimism regarding early market response for AQVESME, with 44 prescriptions written by REMS-certified physicians as of January 30, reflecting strong recognition of clinical value and expected to drive future revenue growth.
See More
Agios Pharmaceuticals Reports Q4 2025 Earnings and FDA Approval
- Earnings Report: Agios Pharmaceuticals reported a FY GAAP EPS of -$7.12, missing estimates by $0.06, indicating ongoing challenges in profitability that may affect investor confidence.
- Revenue Growth: The company achieved revenue of $54.03 million, a 48.1% year-over-year increase, exceeding market expectations by $7.91 million, suggesting strong product sales and market demand that could lay the groundwork for future growth.
- FDA Drug Approval: Agios' AQVESME (mitapivat) received FDA approval for treating anemia in adults with alpha and beta thalassemia, marking a significant advancement in the company's blood disorder treatment portfolio, potentially driving future sales growth.
- Investor Conference: Agios presented at the 44th Annual J.P. Morgan Healthcare Conference, enhancing its visibility among investors and potentially attracting more investment and partnership opportunities.
See More
Agios Pharmaceuticals Reports Key 2025 Financial Highlights
- Significant Revenue Growth: In Q4 2025, net revenues for PYRUKYND® (mitapivat) reached $16 million in the U.S., representing a 49% increase from Q4 2024, reflecting the company's sustained commercial focus in the PK deficiency space and a strong launch of AQVESME™ (mitapivat) in the thalassemia market.
- FDA Approval of New Drug: AQVESME™ received FDA approval in December 2025 as the only medication for treating anemia in adults with non-transfusion-dependent and transfusion-dependent alpha or beta-thalassemia, which is expected to significantly enhance the company's market share and brand influence in this area.
- R&D Progress on Track: Agios has fully enrolled its Phase 2 trial of tebapivat for sickle cell disease, with topline results expected in the second half of 2026, laying a solid foundation for further development in this therapeutic area.
- Strong Financial Position: As of December 31, 2025, the company reported $1.2 billion in cash, cash equivalents, and marketable securities, which, despite a decrease from 2024, remains sufficient to support the U.S. commercial launch of AQVESME and advance other clinical programs.
See More
Agios Pharmaceuticals to Announce Q4 Earnings on February 12
- Earnings Announcement: Agios Pharmaceuticals is set to release its Q4 2023 earnings report on February 12 before market open, with consensus EPS estimates at -$1.95 and revenue at $12.06 million, indicating challenges in profitability.
- Earnings Estimate Adjustments: Over the past three months, EPS estimates have seen no upward revisions and four downward revisions, reflecting a weakening analyst confidence in the company's future earnings, while revenue estimates have experienced two upward and three downward revisions, indicating cautious market sentiment regarding sales growth.
- FDA Drug Approval: Agios' AQVESME (mitapivat) has received FDA approval for treating anemia in adults with alpha and beta thalassemia, which could provide a new revenue stream and strengthen its market position in the blood disorder treatment sector.
- Market Reaction: Following a recent stock selloff, Leerink upgraded Agios to Outperform, suggesting a positive outlook from analysts regarding the company's future performance, which may attract more investor interest.
See More
Key Earnings Reports and Economic Outlook This Week
- DuPont Earnings Expectations: DuPont is expected to report earnings of $0.43 per share and revenue of $1.69 billion for Q4 2025, with analysts noting ongoing pressure in short-cycle businesses, while slight improvements in the automotive sector may influence investor sentiment.
- Cisco's AI Focus: Cisco anticipates earnings of $1.02 per share and revenue of $15.1 billion for Q2 FY2026, with CEO highlighting a major multi-year campus networking refresh, making AI infrastructure demand a critical growth driver.
- Importance of Employment Report: The January employment report is expected to show an addition of 80,000 nonfarm payrolls and an unchanged unemployment rate of 4.4%, directly impacting private consumption and U.S. GDP, making it crucial for investors to monitor.
- Consumer Price Index Insights: The January CPI is projected to increase by 2.5% year-over-year, with core CPI rising by 2.6%, providing essential inflation details despite not being the Fed's preferred measure, particularly regarding persistent shelter cost inflation.
See More
UiPath to Join S&P Midcap 400 Index Effective January 2, 2026
- Market Focus: UiPath Inc. announced it will join the S&P Midcap 400 Index on January 2, 2026, replacing Synovus Financial Corp., a move expected to enhance the company's visibility and investor confidence.
- Stock Price Surge: Following this announcement, UiPath shares rose 6.8% to $17.05 in after-hours trading, reflecting market optimism regarding its future performance.
- FDA Approval: Agios Pharmaceuticals' AQVESME™ (mitapivat) received FDA approval for treating anemia in adults with alpha- or beta-thalassemia, although its stock fell 1.4%, this approval could pave the way for future sales growth.
- Stock Buyback Plan: Ramaco Resources announced a $100 million stock repurchase plan, with shares jumping 7.1% in after-hours trading, indicating the company's confidence in its value and potentially attracting more investor interest.
See More
Agios Pharmaceuticals Q4 2025 Earnings Call Insights
- AQVESME Launch Strategy: CEO Brian Goff emphasized that Agios will focus on executing a high-impact launch of AQVESME for thalassemia treatment in the U.S. in 2026, which is expected to enhance the company's market share and lay the groundwork for future expansions.
- PYRUKYND Revenue Growth: In Q4 2025, PYRUKYND net revenue reached $20 million, reflecting an impressive 86% year-on-year growth, indicating the effectiveness of the company's commercialization strategy in the PK deficiency market, with projected revenues of $45 million to $50 million in 2026.
- Strong Financial Position: Agios ended 2025 with approximately $1.2 billion in cash and cash equivalents, providing flexibility for the AQVESME launch and other R&D projects, showcasing the company's confidence and capability in future investments.
- Optimistic Market Outlook: Management expressed optimism regarding early market response for AQVESME, with 44 prescriptions written by REMS-certified physicians as of January 30, reflecting strong recognition of clinical value and expected to drive future revenue growth.
See More
Agios Pharmaceuticals Reports Q4 2025 Earnings and FDA Approval
- Earnings Report: Agios Pharmaceuticals reported a FY GAAP EPS of -$7.12, missing estimates by $0.06, indicating ongoing challenges in profitability that may affect investor confidence.
- Revenue Growth: The company achieved revenue of $54.03 million, a 48.1% year-over-year increase, exceeding market expectations by $7.91 million, suggesting strong product sales and market demand that could lay the groundwork for future growth.
- FDA Drug Approval: Agios' AQVESME (mitapivat) received FDA approval for treating anemia in adults with alpha and beta thalassemia, marking a significant advancement in the company's blood disorder treatment portfolio, potentially driving future sales growth.
- Investor Conference: Agios presented at the 44th Annual J.P. Morgan Healthcare Conference, enhancing its visibility among investors and potentially attracting more investment and partnership opportunities.
See More
Agios Pharmaceuticals Reports Key 2025 Financial Highlights
- Significant Revenue Growth: In Q4 2025, net revenues for PYRUKYND® (mitapivat) reached $16 million in the U.S., representing a 49% increase from Q4 2024, reflecting the company's sustained commercial focus in the PK deficiency space and a strong launch of AQVESME™ (mitapivat) in the thalassemia market.
- FDA Approval of New Drug: AQVESME™ received FDA approval in December 2025 as the only medication for treating anemia in adults with non-transfusion-dependent and transfusion-dependent alpha or beta-thalassemia, which is expected to significantly enhance the company's market share and brand influence in this area.
- R&D Progress on Track: Agios has fully enrolled its Phase 2 trial of tebapivat for sickle cell disease, with topline results expected in the second half of 2026, laying a solid foundation for further development in this therapeutic area.
- Strong Financial Position: As of December 31, 2025, the company reported $1.2 billion in cash, cash equivalents, and marketable securities, which, despite a decrease from 2024, remains sufficient to support the U.S. commercial launch of AQVESME and advance other clinical programs.
See More
Agios Pharmaceuticals to Announce Q4 Earnings on February 12
- Earnings Announcement: Agios Pharmaceuticals is set to release its Q4 2023 earnings report on February 12 before market open, with consensus EPS estimates at -$1.95 and revenue at $12.06 million, indicating challenges in profitability.
- Earnings Estimate Adjustments: Over the past three months, EPS estimates have seen no upward revisions and four downward revisions, reflecting a weakening analyst confidence in the company's future earnings, while revenue estimates have experienced two upward and three downward revisions, indicating cautious market sentiment regarding sales growth.
- FDA Drug Approval: Agios' AQVESME (mitapivat) has received FDA approval for treating anemia in adults with alpha and beta thalassemia, which could provide a new revenue stream and strengthen its market position in the blood disorder treatment sector.
- Market Reaction: Following a recent stock selloff, Leerink upgraded Agios to Outperform, suggesting a positive outlook from analysts regarding the company's future performance, which may attract more investor interest.
See More
Key Earnings Reports and Economic Outlook This Week
- DuPont Earnings Expectations: DuPont is expected to report earnings of $0.43 per share and revenue of $1.69 billion for Q4 2025, with analysts noting ongoing pressure in short-cycle businesses, while slight improvements in the automotive sector may influence investor sentiment.
- Cisco's AI Focus: Cisco anticipates earnings of $1.02 per share and revenue of $15.1 billion for Q2 FY2026, with CEO highlighting a major multi-year campus networking refresh, making AI infrastructure demand a critical growth driver.
- Importance of Employment Report: The January employment report is expected to show an addition of 80,000 nonfarm payrolls and an unchanged unemployment rate of 4.4%, directly impacting private consumption and U.S. GDP, making it crucial for investors to monitor.
- Consumer Price Index Insights: The January CPI is projected to increase by 2.5% year-over-year, with core CPI rising by 2.6%, providing essential inflation details despite not being the Fed's preferred measure, particularly regarding persistent shelter cost inflation.
See More
UiPath to Join S&P Midcap 400 Index Effective January 2, 2026
- Market Focus: UiPath Inc. announced it will join the S&P Midcap 400 Index on January 2, 2026, replacing Synovus Financial Corp., a move expected to enhance the company's visibility and investor confidence.
- Stock Price Surge: Following this announcement, UiPath shares rose 6.8% to $17.05 in after-hours trading, reflecting market optimism regarding its future performance.
- FDA Approval: Agios Pharmaceuticals' AQVESME™ (mitapivat) received FDA approval for treating anemia in adults with alpha- or beta-thalassemia, although its stock fell 1.4%, this approval could pave the way for future sales growth.
- Stock Buyback Plan: Ramaco Resources announced a $100 million stock repurchase plan, with shares jumping 7.1% in after-hours trading, indicating the company's confidence in its value and potentially attracting more investor interest.
See More
