Agios Pharmaceuticals Receives FDA Approval for AQVESME
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 24 2025
0mins
Should l Buy AGIO?
Source: Benzinga
Agios Pharmaceuticals Inc. experienced a significant price increase of 15.98%, reaching a 5-day high. This surge follows the announcement of FDA approval for AQVESME, the only treatment approved for both non-transfusion-dependent and transfusion-dependent thalassemia.
The FDA approval of AQVESME marks a major milestone for Agios, as it becomes the sole FDA-approved medication for thalassemia, expected to enhance patient quality of life. The approval is based on successful Phase 3 trials demonstrating the drug's effectiveness in improving anemia and reducing transfusion needs. This news is anticipated to positively influence Agios's stock performance, despite the broader market context where the Nasdaq-100 is down slightly.
The implications of this approval are significant for Agios, as AQVESME is expected to be commercially available by late January 2026, potentially driving substantial revenue growth and solidifying the company's position in the rare disease market.
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Analyst Views on AGIO
Wall Street analysts forecast AGIO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AGIO is 36.38 USD with a low forecast of 25.00 USD and a high forecast of 62.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
6 Buy
3 Hold
0 Sell
Moderate Buy
Current: 26.570
Low
25.00
Averages
36.38
High
62.00
Current: 26.570
Low
25.00
Averages
36.38
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.
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Agios Pharmaceuticals (AGIO) Shares Surge 18.6% Following FDA Approval of Aqvesme
- FDA Approval: Agios Pharmaceuticals announced that its drug Aqvesme received FDA approval, becoming the only treatment for non-transfusion-dependent and transfusion-dependent alpha or beta-thalassemia, which is expected to significantly enhance its market competitiveness.
- Stock Price Rebound: Following the FDA approval announcement, AGIO's stock surged 18.6% to $29.17, with trading volume exceeding average levels, indicating strong investor confidence in the company's prospects.
- Earnings Outlook: Although the upcoming quarterly report is expected to show a loss of $1.96 per share, a 12.6% year-over-year decline, revenues are projected at $11.14 million, reflecting a 3.8% increase from the previous year, demonstrating resilience amid challenges.
- Market Attention: AGIO's consensus EPS estimate has remained unchanged over the past 30 days, and despite the stock's rise, investors should monitor future earnings estimate revisions to assess whether the stock can maintain its upward momentum.
See More
Agios Receives FDA Approval for AQVESME to Treat Thalassemia
- Exclusive Approval: AQVESME becomes the only FDA-approved treatment for both non-transfusion-dependent and transfusion-dependent thalassemia, marking a significant breakthrough in treatment options for this severe disease and is expected to greatly improve patients' quality of life.
- Clinical Trial Success: In the global randomized double-blind ENERGIZE and ENERGIZE-T Phase 3 trials, 452 patients participated, demonstrating that AQVESME significantly outperformed placebo in improving anemia and fatigue, meeting all primary and key secondary efficacy endpoints.
- Market Outlook: AQVESME is expected to be available in late January 2026, providing a new treatment option for approximately 6,000 adult thalassemia patients in the U.S., filling a critical gap in the market.
- Investor Conference: Agios will host an investor conference call on December 24, 2025, to discuss the FDA approval of AQVESME, further enhancing investor confidence in the company's future growth.
See More
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- 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.
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- 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
HC Wainwright Raises Agios Price Target to $62
- Price Target Increase: HC Wainwright & Co. raised the price target for Agios Pharmaceuticals from $48 to $62, with analyst Emily Bodnar maintaining a Buy rating, indicating strong confidence in the company's future growth prospects.
- Market Performance: Agios Pharmaceuticals shares closed at $29.17 on Wednesday, suggesting that despite the price target increase, the current stock price remains undervalued compared to the new target, reflecting market skepticism about its potential.
- Competitive Analysis: In contrast to Agios's price target increase, Lexaria Bioscience's target was cut to $1.5, highlighting significant differences in market outlooks for various biotech companies.
- Capital One Outlook: BTIG raised the price target for Capital One Financial from $264 to $308, with analyst Vincent Caintic maintaining a Buy rating, reflecting optimism about the financial institution's future performance.
See More
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- Credit Support: Galectin Therapeutics Inc. secured a $10 million credit line, ensuring funding to cover expected expenditures through March 2027, thereby enhancing its R&D capabilities in the NASH cirrhosis treatment space.
- FDA Guidance: The FDA provided written feedback on Galectin's regulatory pathway for belapectin, marking a significant advancement in the company's drug development efforts, which could expedite its product's market entry.
- Market Reaction: Galectin's stock rose by 1% to $4.03 in Wednesday's trading, reflecting investor optimism regarding its financing and FDA support.
- Strategic Implications: This credit line and FDA guidance will provide Galectin with essential funding and regulatory backing in the competitive biopharmaceutical market, aiding its future clinical trials and market launch efforts.
See More
Agios Pharmaceuticals (AGIO) Shares Surge 18.6% Following FDA Approval of Aqvesme
- FDA Approval: Agios Pharmaceuticals announced that its drug Aqvesme received FDA approval, becoming the only treatment for non-transfusion-dependent and transfusion-dependent alpha or beta-thalassemia, which is expected to significantly enhance its market competitiveness.
- Stock Price Rebound: Following the FDA approval announcement, AGIO's stock surged 18.6% to $29.17, with trading volume exceeding average levels, indicating strong investor confidence in the company's prospects.
- Earnings Outlook: Although the upcoming quarterly report is expected to show a loss of $1.96 per share, a 12.6% year-over-year decline, revenues are projected at $11.14 million, reflecting a 3.8% increase from the previous year, demonstrating resilience amid challenges.
- Market Attention: AGIO's consensus EPS estimate has remained unchanged over the past 30 days, and despite the stock's rise, investors should monitor future earnings estimate revisions to assess whether the stock can maintain its upward momentum.
See More
Agios Receives FDA Approval for AQVESME to Treat Thalassemia
- Exclusive Approval: AQVESME becomes the only FDA-approved treatment for both non-transfusion-dependent and transfusion-dependent thalassemia, marking a significant breakthrough in treatment options for this severe disease and is expected to greatly improve patients' quality of life.
- Clinical Trial Success: In the global randomized double-blind ENERGIZE and ENERGIZE-T Phase 3 trials, 452 patients participated, demonstrating that AQVESME significantly outperformed placebo in improving anemia and fatigue, meeting all primary and key secondary efficacy endpoints.
- Market Outlook: AQVESME is expected to be available in late January 2026, providing a new treatment option for approximately 6,000 adult thalassemia patients in the U.S., filling a critical gap in the market.
- Investor Conference: Agios will host an investor conference call on December 24, 2025, to discuss the FDA approval of AQVESME, further enhancing investor confidence in the company's future growth.
See More
