Agios Pharmaceuticals: EU thalassemia approved without REMS; further validates launch trajectory

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Agios Pharmaceuticals: EU thalassemia approved without REMS; further validates launch trajectory

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Agios Pharmaceuticals

EU thalassemia approved without REMS;

further validates launch trajectory

Maintain Rating: BUY | PO: 41.00 USD | Price: 28.79 USD

EU approval adds to a cleaner commercial story 22 May 2026

Agios’ EU approval for PYRUKYND (mitapivat) in adults with transfusion-dependent and Equity

non-transfusion-dependent alpha- or beta-thalassemia is another positive proof point for

Alec W. Stranahan

the global mitapivat franchise. The decision to approve under the PYRUKYND label without Research Analyst

a REMS requirement should ease uptake and reinforces our view that thalassemia can be a BofAS +1 646 743 2109

meaningful revenue driver (see our recent KOL work in thal report). We continue to expect alec.stranahan@bofa.com

2026 to be a building year as the foundation for thal solidifies, with EU expansion likely

more a 2027 contributor to the topline (see our 1Q26 launch update report). We leave our

model unchanged, as we had already assumed approval in the EU and contribution to Stock Data

revenues beginning 2027e. We maintain our Buy rating and $41 PO.

Price 28.79 USD

Strong global footprint, we see close to $1B sales at peak Price Objective 41.00 USD

Mitapivat is now approved for thalassemia in the U.S., Saudi Arabia, UAE and EU, with Date Established 20-Apr-2026

the EU approval covering all member states and representing the only medicine Investment Opinion C-1-9

approved for both transfusion-dependent and non-transfusion-dependent alpha- or beta- 52-Week Range 22.24 USD - 46.00 USD

thalassemia. We currently model $874M in peak thal sales across the US/EU, which Mrkt Val (mn) / Shares Out 1,712 USD / 59.5

assumes 13-15% peak share.