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XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

Form 8-K - Current report - Item 5.03 Item 9.01

Agios Pharmaceuticals Inc

Announcement: AGIO 8-K Special Filing

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Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

Agios Pharmaceuticals' PYRUKYND receives marketing authorization in the EU for the treatment of PK deficiency, boosting investor confidence. 
Current Analysis##:
Agios Pharmaceuticals, a biopharmaceutical company, focuses on creating unique small molecule medicines for rare diseases. It sold its oncology business, bolstering PYRUKYND’s prospects. In February 2022, the FDA approved combining PYRUKYND with wild-type and mutant PK in adults with hemolytic anemia causing PK deficiency. European Commission approved it for adults in November and December 2022. Analysts predict PYRUKYND’s success and Agios’ strategic focus with a cutting-edge organizational transformation will lead to growth.
Forward-Looking Analysis##:
Agios’ PAH research for PKU and novel PK activator, AG-946, for LR MDS and hemolytic anemia shows promising results. Its focus on pipeline growth through in-licensing and acquisition while prioritizing late-stage research may provide long-term growth. However, risks associated with clinical trials and regulatory approval remain. Investors should be in it for the long haul.

Announcement: AGIO 10-K Annual Report

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Form 8-K - Current report - Item 2.02 Item 9.01

Analyst Summary:
Agios Pharmaceuticals reported its financial results for Q4 and FY 2022. The company generated $11.7 million in net revenue for the full year, mostly driven by the approval of its first disease-modifying treatment for adults with pyruvate kinase (PK) deficiency. The company had $1.4 billion in Cash, Cash Equivalents, and Marketable Securities as of December 31, 2022. Agios reported regulatory approvals for adults with PK deficiency in Europe, along with marketing authorization for adults with sickle cell disease and thalassemia. The company achieved its ambitious enrollment targets in pivotal trials in thalassemia and sickle cell disease. It also appointed Tsveta Milanova as a Chief Commercial Officer, who will help to execute their plans to launch further indications by 2026. The company expects to file an investigational new drug (IND) application for phenylalanine hydroxylase (PAH) stabilizer for the treatment of phenylketonuria (PKU) later this year. The executive team announced that Agios would become cash-flow positive with cash, cash equivalents, and the anticipated product revenue, without the need to raise additional equity. Overall, Agios continues to focus on R&D activities that will reinforce its position as a leader in cellular metabolism pioneering therapies for rare diseases.

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Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]

Announcement: AGIO SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

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