AGIO STOCK ALERT: Levi & Korsinsky Notifies Agios Pharmaceuticals, Inc. Investors of an Ongoing Investigation Accessibility StatementSkip NavigationNEW YORK, March 25, 2026 /PRNewswire/ -- Levi & Korsinsky notifies investors that it has commenced an investigation of Agios Pharmaceuticals, Inc. ("Agios Pharmaceuticals, Inc.") (NASDAQ: AGIO) concerning possible violations of federal securities laws.On November 19, 2025, Agios reported topline results from its RISE UP Phase 3 trial of Mitapivat in Sickle Cell ...

Key Takeaways AGIO shares dropped after mixed phase III RISE UP data for Pyrukynd in SCD weakened investor confidence. AGIO said the study improved hemoglobin levels but failed to cut the annualized sickle cell pain crisis rates.Agios faced a three-month FDA review extension for mitapivat in thalassemia before the U.S. approval. Shares of Agios Pharmaceuticals (AGIO) have plunged 23% over the past six months, primarily due to pipeline and regulatory setbacks, which have dampened investor confidence in the c ...

Lost Money on Agios Pharmaceuticals, Inc.(AGIO)? Contact The Gross Law Firm Regarding an Ongoing Investigation Accessibility StatementSkip NavigationNEW YORK, March 17, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Agios Pharmaceuticals, Inc.:Due to the forgoing, The Gross Law Firm is investigating potential securities fraud claims on behalf of certain Agios Pharmaceuticals, Inc. investors. If you incurred a loss on your AGIO investment, please contact us using the l ...

Core Viewpoint - Agios Pharmaceuticals, Inc. is under investigation for potential violations of federal securities laws following disappointing results from its Phase 3 trial of Mitapivat in Sickle Cell Disease, which led to a significant drop in stock price [1]. Group 1: Trial Results - On November 19, 2025, Agios reported topline results from its RISE UP Phase 3 trial, which met one primary endpoint but failed to achieve a statistically significant improvement in the annualized rate of pain crises [1]. - The key secondary endpoint, change from baseline in PROMIS Fatigue, was also not met during the trial [1]. Group 2: Stock Market Reaction - Following the trial results, Agios' stock price fell by $22.33 per share, opening at $23.16 per share [1].

Core Viewpoint - Agios Pharmaceuticals, Inc. is under investigation for potential violations of federal securities laws following the mixed results of its RISE UP Phase 3 trial for Mitapivat in Sickle Cell Disease, which led to a significant drop in its stock price [1]. Group 1: Trial Results - On November 19, 2025, Agios reported topline results from its RISE UP Phase 3 trial, which met one primary endpoint but failed to achieve a statistically significant improvement in the annualized rate of pain crises [1]. - The key secondary endpoint, which was the change from baseline in PROMIS Fatigue, was also not met [1]. Group 2: Stock Price Impact - Following the trial results, Agios' stock price fell by $22.33 per share, opening at $23.16 per share [1].

Summary of Agios Pharmaceuticals FY Conference Call Company Overview - **Company**: Agios Pharmaceuticals (NasdaqGS:AGIO) - **Event**: FY Conference Call on March 02, 2026 - **Key Speakers**: Brian Goff (CEO), Tsveta Milanova (Chief Commercial Officer) Key Industry and Company Insights 1. Product Launch and Approval - Agios received approval for **AQVESME (mitapivat)** for treating thalassemia, with the launch currently underway [4][30] - The company is expanding its **pyruvate kinase activation franchise** with mitapivat and pursuing additional studies in sickle cell disease and myelodysplastic syndrome (MDS) [4][5] 2. Clinical Trials and Data - The **RISE UP Phase 3 study** for sickle cell disease showed a **41%** hemoglobin improvement in patients, although it did not meet statistical significance for vaso-occlusive crisis reduction [11][12] - The average hemoglobin increase was **1.6 grams per deciliter**, a significant finding as such improvements typically require transfusions [12] - Agios is preparing for a **pre-sNDA meeting** with the FDA to discuss the regulatory path for sickle cell disease [15][16] 3. Market Dynamics and Commercial Strategy - There is strong excitement among clinicians for mitapivat as an anti-hemolytic agent, focusing on hemoglobin levels and hemolytic parameters rather than vaso-occlusive crises [22][23] - The company anticipates a **$1 billion commercial opportunity** for PK deficiency and thalassemia globally, with the majority of revenue expected from the U.S. market [50][51] 4. Launch Trajectory and Patient Segmentation - The launch is expected to start with **transfusion-dependent patients**, gradually expanding to **non-transfusion-dependent patients** over time [40][42] - Approximately **two-thirds** of diagnosed thalassemia patients in the U.S. are non-transfusion-dependent, which will drive future growth [42] 5. Regulatory and Competitive Landscape - Agios is not concerned about the upcoming data from a competitor, **etavopivat**, as they believe their clinical benefits are well-established [29] - The company is also exploring pediatric trials for both thalassemia and sickle cell disease, aiming to extend treatment options to younger populations [56][58] 6. Future Pipeline Developments - Agios is developing **tebapivat** for MDS, focusing on efficacy, tolerability, and route of administration as key differentiators [64][65] - The company is also working on **AG-236**, a TMPRSS6 siRNA targeting polycythemia vera, with expectations for phase 1 data in 2026 [70][73] Additional Important Insights - Initial feedback from physicians and payers regarding AQVESME has been positive, with early prescriptions indicating a healthy start to the launch [30][31] - The company is confident in navigating payer dynamics, especially given the rarity of thalassemia, which may ease reimbursement challenges [31][32] - Agios emphasizes the importance of a broad label for AQVESME, which positions it favorably against existing treatments [36][37] This summary encapsulates the key points discussed during the Agios Pharmaceuticals FY Conference Call, highlighting the company's strategic direction, product developments, and market opportunities.

Core Insights - Agios Pharmaceuticals has received approval from the Emirates Drug Establishment for PYRUKYND (mitapivat) to treat adult patients with both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia in the UAE, making it the only approved medication for this patient group in the region [1][7][4] Company Overview - Agios Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing innovative medicines for patients with rare diseases, particularly in the field of hematology [33] - The company has a distribution agreement with NewBridge Pharmaceuticals to facilitate the regulatory filings and commercialization of PYRUKYND in the Gulf Cooperation Council (GCC) region [3] Industry Context - Thalassemia is a rare inherited blood disorder that significantly impacts hemoglobin production, leading to anemia and various complications [5][6] - The prevalence of thalassemia in the GCC region is approximately 70,000 individuals, highlighting the urgent need for effective treatment options [8] Clinical Trials - The approval of PYRUKYND is based on the results from the ENERGIZE and ENERGIZE-T Phase 3 clinical trials, which demonstrated its efficacy and safety in treating thalassemia [2][9] - The ENERGIZE trial involved 194 patients with non-transfusion-dependent thalassemia, while the ENERGIZE-T trial included 258 patients with transfusion-dependent thalassemia, both trials assessing various endpoints related to hemoglobin response and transfusion reduction [10][11]

Company Overview - Agios Pharmaceuticals, Inc. is a biopharmaceutical company focused on therapies for rare hematologic diseases, utilizing expertise in cellular metabolism [6] - The company's strategy involves advancing innovative treatments from research to commercialization, targeting high unmet medical needs [6] - Agios has a pipeline anchored by PYRUKYND and ongoing clinical programs, aiming to establish a competitive position in the rare disease space [6] Financial Performance - As of February 17, 2026, Agios Pharmaceuticals has a market capitalization of $1.63 billion [4] - The company reported a total revenue of $54.03 million for the trailing twelve months (TTM) [4] - Agios posted a net income loss of $412.78 million for the TTM [4] - The stock price was $27.82, reflecting a 17% decline over the past year, underperforming the S&P 500's approximately 13% gain [8] Recent Developments - Commodore Capital sold all 2,338,287 shares of Agios Pharmaceuticals in the fourth quarter, resulting in a decrease of approximately $93.86 million in the position's quarter-end value [1][2] - The company experienced a significant stock price drop of 50% in one day following the Phase 3 RISE UP trial of mitapivat, which failed to reduce sickle cell pain crises [10] - Agios reported a net loss of $108 million in the fourth quarter, compared to a $96.5 million loss in the same quarter the previous year [10] Investment Context - The current investment climate in biotech is shifting towards momentum stocks, with Agios being perceived as underperforming due to execution challenges rather than a lack of assets [11] - The company's capital is concentrated in clinical-stage immunology names, with Agios positioned slightly outside this core theme [11]

Company Overview - Agios Pharmaceuticals is a clinical-stage biopharmaceutical company focused on therapies for rare genetic diseases related to cellular metabolism [6][7] - The company has a marketed product, PYRUKYND (mitapivat), for hemolytic anemias and a pipeline candidate, AG-946, currently in Phase I clinical trials [7] - As of February 13, 2026, Agios shares were priced at $27.96, with a market capitalization of $1.63 billion and a revenue of $54.03 million over the trailing twelve months [4][6] Recent Developments - Rock Springs Capital Management sold 159,379 shares of Agios Pharmaceuticals in Q4 2025, with an estimated transaction value of $5.59 million [1][2] - Following this sale, Rock Springs' position in Agios was valued at $21.75 million, a decrease of $16.72 million from the previous period, reflecting both trading and market price changes [2][10] - The fund's stake in Agios now represents 1.12% of its reported assets under management (AUM), down from 2.2% in the prior quarter [6][10] Market Performance - Agios shares have declined by 16.0% over the past year, underperforming the S&P 500 by 27.8 percentage points [6][10] - The stock price fell significantly after the Phase 3 RISE UP trial of mitapivat met its hemoglobin endpoint but failed to reduce sickle cell pain crises, leading to a 50% drop in November 2025 [9][10] Strategic Focus - Agios targets patients with rare blood disorders, primarily focusing on healthcare providers, specialty clinics, and institutions treating hemolytic anemias [7][8] - The company's strategy emphasizes advancing innovative treatments for underserved patient populations, which supports its competitive position in the biotechnology sector [8]

Financial Performance - Agios Pharmaceuticals reported a loss of $1.85 per share in Q4 2025, which is narrower than the Zacks Consensus Estimate of a loss of $1.97 and compared to a loss of $1.74 per share in the same quarter last year [1][10] - Total revenues for Q4 2025 were $20 million, exceeding the Zacks Consensus Estimate of $10 million [1] - For the full year 2025, total revenues reached $54 million, reflecting a 48% year-over-year increase [10] Product Performance - The lead drug, mitapivat, is marketed as Pyrukynd and Aqvesme, with Pyrukynd approved for treating hemolytic anemia in adults with pyruvate kinase deficiency and Aqvesme for anemia in adults with alpha- or beta-thalassemia [2] - Pyrukynd generated $16 million in product revenues in the U.S., marking a 49% year-over-year increase and a 24% sequential increase [5] - Aqvesme was launched in the U.S. in December 2025 and is reported to have a strong start [3] Market Developments - Outside the U.S., mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications, with a positive opinion from the European Medicines Agency for label expansion in thalassemia [4] - Agios recorded $4 million in revenues from Pyrukynd in the ex-U.S. market, primarily due to inventory stocking as the market transitioned to commercial supply [8] Research and Development - Research and development expenses increased by approximately 6.4% year-over-year to $88.1 million in Q4 2025, driven by higher costs related to pipeline development [9] - The company is developing mitapivat for sickle cell disease (SCD) and plans to engage with the FDA in Q1 2026 before filing for approval [11][13] - Agios is also developing another candidate, tebapivat, for SCD, with patient enrollment completed and top-line results expected in the second half of 2026 [13] Stock Performance - Over the past year, Agios' stock has decreased by 15.7%, while the industry has seen an increase of 17.9% [4]