Core Viewpoint - The Schall Law Firm is investigating Agios Pharmaceuticals, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [2]. Group 1: Investigation Details - The investigation centers on whether Agios issued false or misleading statements or failed to disclose critical information to investors [2]. - On September 4, 2025, Agios announced that the FDA extended the PDUFA goal date for the supplemental New Drug Application of PYRUKYND® by three months to December 7, 2025 [2]. - Following this announcement, Agios shares dropped by over 11% the next day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

Group 1 - Agios Pharmaceuticals, Inc. is currently under investigation for potential fraud, providing an opportunity for investors to join the legal proceedings with the Schall Law Firm [1] - The investigation may involve allegations of misleading statements or omissions that could have affected the stock price and investor decisions [1] - Investors are encouraged to consider their legal options in light of the ongoing investigation [1]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Agios Pharmaceuticals and its officers or directors, following a significant stock price drop due to a delayed FDA review of a key drug [1][3]. Group 1: Company Overview - Agios Pharmaceuticals, Inc. is under investigation for possible securities fraud related to its business practices [1]. - The company’s stock price fell by $4.48, or 11.03%, closing at $36.13 per share on September 4, 2025, after the announcement of a three-month extension for the FDA review of its drug PYRUKYND® [3]. Group 2: Regulatory Developments - The U.S. FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND® to December 7, 2025, impacting investor sentiment and stock performance [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices by Agios Pharmaceuticals following a delay in FDA review of its drug PYRUKYND® [1][2]. Group 1: Company Overview - Agios Pharmaceuticals, Inc. is under investigation for possible securities fraud related to its business practices [1]. - The company’s stock price dropped by $4.48, or 11.03%, closing at $36.13 per share after the announcement of the FDA's extension of the review date for its drug [2]. Group 2: Regulatory Update - On September 4, 2025, Agios announced that the FDA extended the PDUFA goal date for the supplemental New Drug Application of PYRUKYND® by three months to December 7, 2025 [2].

Company Overview - Agios Pharmaceuticals (NASDAQ: AGIO) has experienced a stock price increase of approximately 29% since April, following Liberation Day [1] - The company is currently facing uncertainty with the upcoming PDUFA decision date, which was originally set for September 7 but has been postponed [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, including cell culture, assay development, and therapeutic research [1] - The analyst has been active in the investment space for five years, focusing on biotechnology companies that are innovating through unique mechanisms of action and first-in-class therapies [1] - The approach combines scientific expertise with financial and market analysis to deliver technically sound and investment-driven research [1] Investment Focus - The analyst plans to cover a range of biotechnology companies at various stages of development, from early clinical pipelines to commercial-stage biotechs [1] - Emphasis will be placed on evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities, while also considering financial fundamentals and valuation [1]

Core Viewpoint - Shares of Agios Pharmaceuticals (AGIO) fell 11% after the FDA extended the review timeline for the supplemental new drug application (sNDA) for Pyrukynd in thalassemia by three months, with a new decision date set for December 7, 2025 [1][7]. Company Developments - The sNDA for Pyrukynd is based on data from two phase III studies, ENERGIZE and ENERGIZE-T, aiming for approval in treating non-transfusion-dependent and transfusion-dependent thalassemia in adults [2]. - Agios submitted a proposed Risk Evaluation and Mitigation Strategy (REMS) to address liver injury risks, which led to the three-month extension of the review timeline [3]. - The FDA had previously expected a decision on September 7, 2025, and the delay may impact the commercial launch timeline, which was initially anticipated before the end of 2025 [8]. Financial Performance - Year-to-date, Agios shares have increased by 10%, outperforming the industry average rise of 4.1% [4]. - Pyrukynd generated sales of $21.2 million in the first half of 2025, marking a 26% year-over-year increase [9]. Ongoing Research - Agios is also conducting late-stage studies, ACTIVATE-Kids and ACTIVATE-KidsT, to evaluate Pyrukynd for treating PK deficiency in pediatric patients [10].

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]

Core Insights - The FDA has extended the PDUFA goal date for Agios Pharmaceuticals' Pyrukynd sNDA by three months to December 7, 2025, due to a proposed REMS submission [1][2] - The REMS submission is a significant amendment but does not involve new efficacy or safety data [2] - Pyrukynd is supported by Phase 3 trial results and has received approval from the Saudi Food and Drug Authority for similar indications [3][4] Company Developments - Agios Pharmaceuticals has entered a distribution agreement with NewBridge Pharmaceuticals to enhance regulatory filings and commercialization of Pyrukynd in the GCC region [4] - Pyrukynd is approved for treating hemolytic anemia in adults with PK deficiency in the U.S. and for PK deficiency in the EU and Great Britain [4] Market Reaction - AGIO stock has decreased by 15.83%, trading at $34.18 [5]

Core Viewpoint - The U.S. FDA has extended the PDUFA goal date for Agios Pharmaceuticals' supplemental New Drug Application (sNDA) for PYRUKYND from September 7, 2025, to December 7, 2025, due to a proposed Risk Evaluation and Mitigation Strategy (REMS) submission to address hepatocellular injury risks [1][2]. Company Overview - Agios Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative medicines for rare diseases, headquartered in Cambridge, Massachusetts [17]. Product Information - PYRUKYND (mitapivat) is an oral pyruvate kinase activator indicated for treating adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia [1][10]. - The sNDA for PYRUKYND is supported by results from the global, randomized, double-blind, placebo-controlled ENERGIZE and ENERGIZE-T Phase 3 trials [3][6]. Clinical Trials - The ENERGIZE trial involved 194 non-transfusion-dependent patients, with a primary endpoint of achieving a hemoglobin response defined as an increase of ≥1.0 g/dL in average hemoglobin concentrations [7]. - The ENERGIZE-T trial included 258 transfusion-dependent patients, focusing on achieving a transfusion reduction response defined as a ≥50% reduction in transfused red blood cell units [8]. Disease Context - Thalassemia is a rare inherited blood disease affecting hemoglobin production, categorized into alpha-thalassemia and beta-thalassemia, leading to anemia and serious complications [4][5]. - Approximately 6,000 adult patients in the U.S. are diagnosed with thalassemia, experiencing significant disease burden and reduced quality of life [5].

Core Viewpoint - Agios Pharmaceuticals has received approval from the Saudi Food and Drug Authority (SFDA) for PYRUKYND (mitapivat) to treat adult patients with both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, marking a significant milestone in providing new treatment options for thalassemia patients in Saudi Arabia [1][2]. Company Overview - Agios Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative medicines for rare diseases, headquartered in Cambridge, Massachusetts [13]. - The company has partnered with NewBridge Pharmaceuticals to facilitate the distribution and commercialization of PYRUKYND in the Gulf Cooperation Council (GCC) region, which includes Saudi Arabia, UAE, Kuwait, Qatar, Oman, and Bahrain [3][5]. Product Information - PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency and is now approved for thalassemia in Saudi Arabia [5][6]. - The approval is based on results from the global, randomized, double-blind, placebo-controlled ENERGIZE and ENERGIZE-T Phase 3 trials [2][4]. Market Potential - The SFDA's approval is significant as it is the first of its kind for thalassemia treatment in Saudi Arabia, addressing a community with high prevalence and limited treatment options [2][4]. - Regulatory applications for PYRUKYND are currently under review in the U.S., UAE, and European Union, with a PDUFA goal date of September 7, 2025, for the U.S. [4].