Agios Pharmaceuticals, Inc. - AGIO STOCK NEWS

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 41^st Annual Virtual Healthcare Conference on March 1, 2021, at 11:40 a.m. ET, followed by the Oppenheimer 31^st 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.