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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) announced significant developments in their recent press release, including the completion of the $1.8 billion sale of their oncology portfolio to Servier. This sale, closed on March 31, 2021, allows Agios to focus on genetically defined diseases. The company plans to file for regulatory approval of mitapivat for PK deficiency in the U.S. this quarter and in the EU mid-2021. Financially, Agios reported a net income of $1.9 billion for Q1 2021, a major increase from a net loss of $40.3 million in Q1 2020, alongside a robust cash position of $2.4 billion.
Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call and live webcast on April 29, 2021, at 8:00 a.m. ET to disclose its Q1 2021 financial results and share business highlights. The call can be accessed by calling 1-877-377-7098 for domestic or 1-631-291-4547 for international participants, using conference ID 4497151. The event will be available for replay on the company’s website after the live broadcast. Agios is focused on developing therapies for genetically defined diseases, with its leading candidate, mitapivat, targeting hemolytic anemias.
Agios Pharmaceuticals (NASDAQ: AGIO) has finalized a $1.8 billion sale of its oncology portfolio to Servier Pharmaceuticals. Following shareholder approval, the transaction allows Agios to focus on advancing its genetically defined disease pipeline, particularly mitapivat, which targets conditions like PK deficiency, thalassemia, and sickle cell disease. Additionally, Agios repurchased approximately 10% of its shares from Bristol-Myers Squibb for $344.5 million, funded by proceeds from the sale. Future milestones include regulatory filings and Phase 3 trials in 2021.
Agios Pharmaceuticals (NASDAQ: AGIO) announced approval from shareholders for the sale of its oncology portfolio to Servier Pharmaceuticals, with approximately 99.9% voting in favor. The transaction is expected to close by March 31, 2021. Following the sale, Agios' board authorized a $1.2 billion share repurchase plan to be executed over the next 12-18 months. This includes plans for open market purchases and block sales.
Agios Pharmaceuticals (NASDAQ: AGIO) announced its sponsorship of Citizen Scientist: Unpacking the Science of Sickle Cell Disease, an initiative by the Sickle Cell Community Consortium to enhance health literacy among sickle cell patients. The initiative includes a podcast series, hosted by leading physicians, to make complex research more accessible to patients and caregivers. Agios emphasizes its commitment to patient-centered care and supports providing critical information for better health management and innovative treatments.
Agios Pharmaceuticals has submitted a Supplemental New Drug Application (sNDA) to the FDA for TIBSOVO® (ivosidenib tablets) to treat previously treated patients with IDH1 mutated cholangiocarcinoma. The company has requested priority review, which could shorten the review process to six months. Cholangiocarcinoma is a rare and aggressive cancer with limited effective therapies, particularly for patients whose disease has progressed after chemotherapy. The sNDA is backed by data from the ClarIDHy study, the only randomized Phase 3 trial for this condition.
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.
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