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Agios Pharma (AGIO)
NASDAQ:AGIO
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Agios Pharma (AGIO) AI Stock Analysis

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AGIO

Agios Pharma

(NASDAQ:AGIO)

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Neutral 59 (OpenAI - 4o)
Rating:59Neutral
Price Target:
$45.00
▲(4.07% Upside)
Agios Pharmaceuticals demonstrates strong growth potential with increasing revenues and a robust pipeline, as highlighted in the earnings call. The stock's undervaluation and positive technical indicators further support its prospects. However, profitability challenges and cash flow inefficiencies are significant risks that weigh on the overall score.
Positive Factors
Strong Revenue Growth
The significant revenue growth indicates strong market demand and successful product adoption, supporting long-term business expansion.
Strategic Partnerships
These partnerships enhance Agios's global presence, opening new markets and driving future revenue growth.
Robust Financial Position
A strong cash position provides financial flexibility to invest in R&D and strategic initiatives, supporting long-term growth.
Negative Factors
Profitability Challenges
Sustained profitability issues could hinder reinvestment in growth and affect long-term financial health.
Cash Flow Inefficiencies
Inefficient cash generation may limit the company's ability to fund operations and strategic initiatives.
Revenue Variability
Revenue variability can create uncertainty in financial planning and may impact investor confidence over time.

Agios Pharma (AGIO) vs. SPDR S&P 500 ETF (SPY)

Agios Pharma Business Overview & Revenue Model

Company DescriptionAgios Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for patients with rare diseases, particularly cancer and genetic metabolic disorders. The company specializes in small molecule drugs that target specific metabolic pathways, with a strong emphasis on advancing treatments that address unmet medical needs. Agios's core products include its lead drug, ivosidenib, which is designed for the treatment of acute myeloid leukemia (AML), and other pipeline candidates aimed at various rare diseases.
How the Company Makes MoneyAgios Pharmaceuticals generates revenue primarily through the sale of its pharmaceutical products, particularly ivosidenib, which has been approved by regulatory authorities and is marketed to healthcare providers. The company also earns revenue from collaborations and partnerships with other pharmaceutical companies that may involve co-development or commercialization agreements. These partnerships often provide upfront payments, milestone payments based on the achievement of specific development or sales targets, and royalties on future sales. Additionally, Agios may receive funding from research grants or government initiatives aimed at supporting the development of therapies for rare diseases.

Agios Pharma Earnings Call Summary

Earnings Call Date:Oct 30, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Feb 12, 2026
Earnings Call Sentiment Positive
The earnings call reflects a positive sentiment with strong financial performance, global regulatory progress, and significant pipeline advancements. However, there are challenges with increased expenses and potential regulatory hurdles related to the REMS program.
Q3-2025 Updates
Positive Updates
PYRUKYND Revenue Growth
Third quarter net PYRUKYND revenue was $12.9 million, an increase of 44% compared to the third quarter of 2024 and a 3% increase compared to the second quarter of 2025.
Global Regulatory Approvals
PYRUKYND received approval for adults with thalassemia in Saudi Arabia and a positive CHMP opinion recommending marketing authorization in Europe for thalassemia treatment.
Strong Financial Position
Agios maintains a strong balance sheet with approximately $1.3 billion in cash and investments, enabling strategic investments in pipeline growth and potential U.S. launches.
Pipeline Progress
Enrollment completed for the Phase IIb trial of Tebapivat in lower-risk MDS, with top line data expected early next year. Progress continues in early-stage programs AG-181 for phenylketonuria and AG-236 for polycythemia vera.
Negative Updates
Increased Expenses
R&D expenses increased by $14.3 million compared to the third quarter of 2024, primarily due to increased clinical trial costs. SG&A expenses also rose by $2.7 million.
Potential REMS Program Impact
The FDA requested a REMS program for PYRUKYND due to hepatocellular injury risk, which could impact the U.S. launch strategy for thalassemia.
Company Guidance
During the Agios Pharmaceuticals third-quarter 2025 conference call, significant guidance was provided, highlighting multiple upcoming catalysts and financial metrics. The company is anticipating a PDUFA date for PYRUKYND (a PK activator) for thalassemia on December 7, following the FDA's request for a REMS program, and expects top-line results from the RISE UP Phase III trial for sickle cell disease by year-end. The third quarter saw $12.9 million in net revenue for PYRUKYND, marking a 44% year-over-year increase. The company maintains a strong financial position with approximately $1.3 billion in cash and investments, positioning them to support potential U.S. launches and advance their rare disease pipeline. Additionally, they achieved enrollment completion in the Phase IIb trial of Tebapivat for lower-risk myelodysplastic syndromes. The team has focused on building a capital-efficient global commercial model and is actively engaging with the thalassemia and sickle cell communities to ensure a successful launch, while continuing to explore strategic business development opportunities to expand their pipeline.

Agios Pharma Financial Statement Overview

Summary
Agios Pharma faces challenges with operational profitability and cash generation, despite maintaining a strong equity base. The income statement shows significant volatility with negative EBIT and EBITDA margins, and cash flow analysis points to negative operating cash flow. However, the balance sheet reveals a strong equity position with a low debt-to-equity ratio.
Income Statement
45
Neutral
Agios Pharma's income statement shows significant volatility with negative EBIT and EBITDA margins, indicating operational challenges. Despite recent revenue growth, net profit margins remain negative, reflecting substantial losses. The company's gross profit margin is positive, but overall profitability is impacted by high operational costs.
Balance Sheet
55
Neutral
The balance sheet reveals a strong equity position with a low debt-to-equity ratio, indicating financial stability. However, the return on equity is negative due to consistent net losses, which could be concerning if trends don't reverse. The equity ratio is solid, suggesting good asset coverage by equity.
Cash Flow
40
Negative
Cash flow analysis points to negative operating cash flow, indicating potential liquidity issues. Free cash flow remains negative, though there's a positive trend in free cash flow growth recently. The operating cash flow to net income ratio is unfavorable, highlighting the need for improved cash generation.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue44.79M36.50M26.82M14.24M0.00203.20M
Gross Profit37.81M32.33M17.32M12.54M-18.78M200.39M
EBITDA-456.65M-420.08M-384.86M-380.48M-337.73M-326.13M
Net Income-401.26M673.73M-352.09M-231.80M1.60B-327.37M
Balance Sheet
Total Assets1.39B1.66B937.12M1.24B1.44B852.95M
Cash, Cash Equivalents and Short-Term Investments952.86M893.71M776.93M783.12M1.02B572.93M
Total Debt44.52M56.99M72.00M85.66M97.09M105.20M
Total Liabilities101.38M122.24M126.10M137.90M145.76M453.45M
Stockholders Equity1.28B1.54B811.02M1.10B1.29B399.50M
Cash Flow
Free Cash Flow-414.09M-391.53M-297.06M-314.36M-413.06M-305.67M
Operating Cash Flow-409.93M-389.84M-296.06M-309.48M-407.32M-290.76M
Investing Cash Flow237.95M363.44M239.57M243.26M1.25B75.75M
Financing Cash Flow10.96M14.44M5.43M2.35M-765.77M261.52M

Agios Pharma Technical Analysis

Technical Analysis Sentiment
Positive
Last Price43.24
Price Trends
50DMA
39.58
Positive
100DMA
38.13
Positive
200DMA
34.68
Positive
Market Momentum
MACD
1.04
Positive
RSI
59.40
Neutral
STOCH
57.60
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AGIO, the sentiment is Positive. The current price of 43.24 is above the 20-day moving average (MA) of 42.10, above the 50-day MA of 39.58, and above the 200-day MA of 34.68, indicating a bullish trend. The MACD of 1.04 indicates Positive momentum. The RSI at 59.40 is Neutral, neither overbought nor oversold. The STOCH value of 57.60 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AGIO.

Agios Pharma Risk Analysis

Agios Pharma disclosed 53 risk factors in its most recent earnings report. Agios Pharma reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Agios Pharma Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
$2.52B-27.57%30.57%
$4.27B-28.43%
$7.86B-0.30-43.30%2.27%22.53%-2.21%
$3.73B-34.12%-79.09%
$2.46B-86.34%30.14%-10.08%
$2.38B-5.80-39.69%-100.00%1.62%
$2.27B4227.22%50.80%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AGIO
Agios Pharma
43.24
-1.59
-3.55%
IBRX
ImmunityBio
2.40
-2.80
-53.85%
DNLI
Denali Therapeutics
16.28
-10.93
-40.17%
NAMS
NewAmsterdam Pharma Company
37.95
19.92
110.48%
RXRX
Recursion Pharmaceuticals
5.52
-1.12
-16.87%
APGE
Apogee Therapeutics
56.59
0.29
0.52%

Agios Pharma Corporate Events

Agios Pharmaceuticals Reports Q3 2025 Financial Results
Oct 31, 2025

Agios Pharmaceuticals, a commercial-stage biopharmaceutical company based in Cambridge, Massachusetts, focuses on developing innovative treatments for rare diseases, particularly in the field of hematology.

Agios Pharmaceuticals Advances Sickle Cell Treatment with Tebapivat Study
Oct 27, 2025

Agios Pharmaceuticals is conducting a Phase 2 clinical study titled A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter, Dose-Finding, Efficacy, and Safety Study of Tebapivat in Participants With Sickle Cell Disease. The study aims to evaluate the efficacy and safety of tebapivat, a drug intended to improve anemia and hemoglobin response in individuals with Sickle Cell Disease (SCD).

Agios Pharmaceuticals’ AG-236 Study: A Potential Game-Changer in Drug Development
Oct 27, 2025

Agios Pharmaceuticals has initiated a Phase 1 clinical trial titled ‘A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of AG-236 Administered as a Subcutaneous Dose in Healthy Male and Female Participants.’ The study aims to evaluate the safety and tolerability of AG-236, a new drug administered via subcutaneous injection, in healthy individuals. This research is significant as it lays the groundwork for further development of AG-236, potentially leading to new therapeutic options.

Agios Pharmaceuticals Advances Mitapivat Study for Sickle Cell Disease and Nephropathy
Oct 27, 2025

Agios Pharmaceuticals is spearheading a new clinical study titled ‘A Phase 2, Open-label, Multicenter Study of Mitapivat in Subjects With Sickle Cell Disease and Nephropathy (RESIST).’ The study aims to evaluate the effect of mitapivat on the albumin creatinine ratio (ACR) in participants suffering from sickle cell disease (SCD) and nephropathy, a significant step in addressing complications associated with these conditions.

Agios Pharmaceuticals’ Promising Study on Tebapivat for Anemia in LR-MDS
Oct 27, 2025

Agios Pharmaceuticals is conducting a study titled ‘A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Open-label (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes.’ The study aims to establish proof of concept for tebapivat in Phase 2a and evaluate its effect on transfusion independence in Phase 2b, targeting patients with lower-risk myelodysplastic syndromes (LR-MDS).

Agios Pharmaceuticals Ensures Continued Access to Mitapivat in New Study
Oct 27, 2025

Agios Pharmaceuticals is conducting a study titled ‘A Rollover Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study.’ The primary objective is to ensure continued access to mitapivat for participants who have completed a previous Agios-sponsored study and lack commercial access to the drug. This study is significant as it addresses ongoing treatment needs for individuals with pyruvate kinase deficiency and hemolytic anemia.

Agios Pharmaceuticals’ AG-181 Study: A Potential Game-Changer in Drug Development
Oct 27, 2025

Study Overview: Agios Pharmaceuticals is conducting a Phase 1 clinical trial titled A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AG-181 in Healthy Participants. The study aims to evaluate the safety and tolerability of AG-181, a new drug, in healthy individuals, focusing on single and multiple ascending doses and the effect of food on its pharmacokinetics. This research is significant as it lays the groundwork for understanding AG-181’s potential therapeutic applications.

Product-Related AnnouncementsRegulatory Filings and Compliance
Agios Pharma’s PYRUKYND Approved by Saudi Authority
Positive
Aug 4, 2025

Agios Pharmaceuticals addressed a recent securities analyst report detailing adverse event data from the FDA’s reporting system concerning its drug PYRUKYND. The report highlighted four patient cases, but Agios maintains that the information has not changed the drug’s established benefit-risk profile. The company continues to prioritize patient safety through rigorous pharmacovigilance processes. Additionally, on August 4, 2025, the Saudi Food and Drug Authority approved PYRUKYND for treating adult patients with specific types of thalassemia, potentially expanding its market reach.

The most recent analyst rating on (AGIO) stock is a Hold with a $56.00 price target. To see the full list of analyst forecasts on Agios Pharma stock, see the AGIO Stock Forecast page.

Agios Pharmaceuticals’ Earnings Call Highlights Growth and Challenges
Aug 2, 2025

Agios Pharmaceuticals’ recent earnings call painted a picture of optimism, underscored by robust revenue growth and strategic advancements. The company showcased its strong financial standing and promising clinical trial developments, although it acknowledged challenges such as increased expenses and potential revenue variability. Overall, Agios is on a promising path toward growth, provided it effectively navigates these hurdles.

Agios Pharmaceuticals Reports Q2 2025 Financial Results
Aug 1, 2025

Agios Pharmaceuticals, a commercial-stage biopharmaceutical company based in Cambridge, Massachusetts, focuses on developing innovative treatments for rare diseases, particularly in the field of hematology.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Oct 31, 2025