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Agios Pharmaceuticals (AGIO) guidance and outlook

Agios Pharmaceuticals' 10-Q filed Nov 5, 2026 makes 21 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 5, 2026

• We are also developing (i) AG-181, our phenylalanine hydroxylase, or PAH, stabilizer for the potential treatment of phenylketonuria, or PKU; (ii) AG-236, an siRNA in-licensed from Alnylam Pharmaceuticals, Inc., or Alnylam, targeting the transmembrane serine protease 6, or TMPRSS6, gene for the potential treatment of polycythemia vera, or PV; and (iii) cevidoplenib, an oral spleen tyrosine kinase, or SYK,…
• Following the sale of our oncology business to Servier in March 2021, we have financed and expect to continue to finance our operations primarily through cash on hand, potential royalty payments with respect to the Retained Earn-Out Rights, the actual and potential future sales of PYRUKYND® and AQVESME® and, potentially, collaborations, strategic alliances, licensing arrangements and other nondilutive strategic…
• We expect to continue to incur significant expenses and net losses until such time we are able to report profitable results.
• We expect that we will continue to incur significant expenses as we continue to advance and expand our commercialization activities for PYRUKYND® and AQVESME®; continue to advance clinical development and regulatory activities for mitapivat, AG-181, AG-236 and cevidoplenib; expand and protect our intellectual property portfolio, including by in-licensing or acquiring assets for pipeline growth; and hire…
• In the future, we expect to continue to generate revenue from product sales of PYRUKYND® and AQVESME®.
• We expect research and development costs related to our portfolio to increase as our product candidate development programs progress.
• As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of and to commercialize these product candidates.
• We have full ownership rights to PYRUKYND® and AQVESME® and expect to fund the future development and commercialization costs related to PYRUKYND® and AQVESME®.
• • We entered into a license agreement with Alnylam for the development and commercialization of products containing or comprised of an siRNA preclinical development candidate discovered by Alnylam and targeting the TMPRSS6 gene, and we are developing a product candidate, AG-236, for the potential treatment of patients with PV.
• We expect to initiate the phase 2 portion of a phase 2/3 trial of AG-236 in patients with PV in the second half of 2026.
• We expect to initiate a phase 3 clinical trial of cevidoplenib in patients with ITP in the first half of 2028, following completion of additional chemistry, manufacturing and controls development work.
• We initiated a phase 1b trial of AG-181 in patients with PKU in the first half of 2026 and expect to confirm proof of mechanism in the second half of 2026.

Agios Pharmaceuticals' latest quarter

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What does Agios Pharmaceuticals expect?

We are also developing (i) AG-181, our phenylalanine hydroxylase, or PAH, stabilizer for the potential treatment of phenylketonuria, or PKU; (ii) AG-236, an siRNA in-licensed from Alnylam Pharmaceuticals, Inc., or Alnylam, targeting the transmembrane serine protease 6, or TMPRSS6, gene for the potential treatment of polycythemia vera, or PV; and (iii) cevidoplenib, an oral spleen tyrosine kinase, or SYK,… Following the sale of our oncology business to Servier in March 2021, we have financed and expect to continue to finance our operations primarily through cash on hand, potential royalty payme

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.