Welcome to our dedicated page for Agios Pharmaceuticals news (Ticker: AGIO), a resource for investors and traders seeking the latest updates and insights on Agios Pharmaceuticals stock.
Agios Pharmaceuticals, Inc. (AGIO) is a biopharmaceutical company at the forefront of pioneering therapies for rare diseases, focusing on cellular metabolism and precision medicine. Based in Cambridge, Massachusetts, Agios is dedicated to discovering and developing breakthrough medications that target cancer, rare genetic metabolic disorders, and metabolic immuno-oncology. The company's core mission is to create transformative small-molecule medicines with a precision approach, enabling genetically or biomarker-defined patient populations to benefit from early proof-of-concept in clinical development.
Agios boasts a robust clinical pipeline, with significant advancements in its leading PK activator, mitapivat. Recent achievements include the Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in thalassemia, demonstrating statistically significant results in reducing transfusion burdens in transfusion-dependent patients. The company is preparing for FDA submissions based on these promising outcomes, aiming to deliver the first oral treatment option for thalassemia patients.
Financially, Agios reported a net revenue of $8.2 million for the first quarter of 2024 from PYRUKYND® (mitapivat) sales, reflecting a 15% increase over the previous quarter. The company's strong cash position, with $714.3 million in cash, cash equivalents, and marketable securities as of March 31, 2024, ensures support for ongoing programs and potential pipeline expansion into 2026. Agios also anticipates a significant financial milestone with potential FDA approval of vorasidenib, expected to bring in $1.1 billion from upfront and milestone payments.
Agios' commitment to diversity and inclusion extends beyond its internal team to its clinical trials, aiming to build trust and support among diverse patient communities. The company’s strategic partnerships and collaborations further reinforce its mission to innovate and deliver life-changing therapies.
To stay updated on the latest developments and financial news about Agios Pharmaceuticals, visit their official website.
Agios Pharmaceuticals (NASDAQ: AGIO) supports the 14th annual Rare Disease Day, emphasizing collaboration with patient communities, particularly for sickle cell disease. The company has launched initiatives including a Facebook Live event featuring experts and patients discussing PK deficiency. Agios raised funds for the Sickle Cell Community Consortium to provide educational resources for affected students during COVID-19. The company's ongoing commitment to addressing health disparities in rare diseases underlines its focus on advancing its genetically defined disease portfolio.
Agios Pharmaceuticals (AGIO) reported strong financial results for 2020, achieving $39.1M in Q4 net revenue from TIBSOVO®, totaling $121.1M for the year, a 102% year-over-year increase. The company plans to close the sale of its oncology portfolio to Servier by March 31, 2021, allowing a focus on genetically defined diseases. Agios outlined a pivotal development program for mitapivat in sickle cell disease, expecting regulatory approval by the end of 2026. The company anticipates full-year 2021 net revenue for TIBSOVO® to be between $160M and $170M.
Agios Pharmaceuticals (NASDAQ:AGIO) announced its participation in two upcoming virtual investor conferences in March 2021. The first is the Cowen 41st Annual Virtual Healthcare Conference on March 1, 2021, at 11:40 a.m. ET, followed by the Oppenheimer 31st Annual Virtual Healthcare Conference on March 17, 2021, at 9:20 a.m. ET. Live webcasts of the presentations will be available on Agios's website, with replays archived for at least two weeks post-event. The company focuses on developing treatments for cancer and genetic diseases through cellular metabolism research.
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) will host a conference call and live webcast on February 25, 2021, at 8:00 a.m. ET to discuss its fourth quarter and year-end 2020 financial results and business highlights. The event will be available for replay on their website shortly after it concludes. Agios focuses on developing innovative medicines for cancer and genetically defined diseases, with a robust pipeline and two approved oncology agents. For further details, visit www.agios.com.
Agios Pharmaceuticals (AGIO) announced significant results from the Phase 3 ACTIVATE-T trial for mitapivat in treating adults with pyruvate kinase (PK) deficiency. In the 24-week treatment period, 37% of patients achieved a ≥33% reduction in transfusion burden, while 22% were transfusion-free. The safety profile remained consistent with previous studies. Agios plans to file for regulatory approval in both the U.S. and EU in 2021, potentially leading to a commercial launch in 2022. This marks a promising step towards addressing treatment gaps in PK deficiency.
Agios Pharmaceuticals has provided a full analysis of final data from its Phase 3 ClarIDHy trial of TIBSOVO (ivosidenib tablets) for patients with previously treated IDH1-mutant cholangiocarcinoma. The analysis showed a median overall survival (OS) of 10.3 months for TIBSOVO compared to 7.5 months for placebo, though statistical significance was not achieved (p=0.093). A high crossover rate from placebo to TIBSOVO was noted. Agios plans to submit a supplemental new drug application in Q1 2021. The trial demonstrates potential for TIBSOVO as a treatment option for this aggressive cancer.
Agios Pharmaceuticals (NASDAQ: AGIO) aims to file for regulatory approval of Mitapivat for treating adults with pyruvate kinase deficiency in the U.S. by Q2 2021 and in the EU by mid-2021. Key milestones for 2021 include initiating pivotal trials for Mitapivat in thalassemia and sickle cell disease, and completing the sale of its oncology portfolio to Servier, generating up to $2 billion. The company’s strategic vision includes commercializing Mitapivat for three indications and achieving cash-flow positivity by 2025.
Agios Pharmaceuticals (NASDAQ:AGIO) announced its presentation schedule for the virtual 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 10:50 a.m. ET. Investors can access a live webcast of the event via the company's website, with a replay available for two weeks post-event. Agios is recognized for its focus on developing novel investigational medicines targeting cancer and genetically defined diseases, boasting a robust research pipeline alongside two approved oncology precision medicines.
Agios Pharmaceuticals announced a transformative strategic shift, focusing on its genetically defined disease portfolio, particularly mitapivat, a potential treatment for hemolytic anemias. The company is selling its oncology portfolio to Servier for up to $2.0 billion, comprising $1.8 billion upfront and $200 million in potential milestone payments. Post-transaction, Agios intends to return at least $1.2 billion to shareholders. The deal aims to bolster Agios' capital and advance its future treatments while enhancing Servier's oncology capabilities.
Agios Pharmaceuticals (NASDAQ: AGIO) announced positive results from the Phase 1 trial of mitapivat for sickle cell disease. The study demonstrated that 55% of patients achieved a hemoglobin increase of ≥1.0 g/dL, with a mean increase of 1.3 g/dL overall. The safety profile was consistent with previous studies, showing mostly Grade 1-2 adverse events. Based on these promising results, Agios plans to initiate a Pivotal Program for mitapivat in 2021. The company will discuss these findings in an investor webcast on December 8, 2020.
FAQ
What is the current stock price of Agios Pharmaceuticals (AGIO)?
What is the market cap of Agios Pharmaceuticals (AGIO)?
What does Agios Pharmaceuticals specialize in?
What are some recent achievements of Agios Pharmaceuticals?
What is the financial status of Agios Pharmaceuticals?
What is mitapivat?
What is the significance of the ENERGIZE-T study results?
How does Agios support diversity in clinical trials?
What are some key upcoming milestones for Agios in 2024?
What strategic partnerships does Agios have?
What is Agios' approach to ESG?
How can I stay updated on Agios Pharmaceuticals?
