Agios Pharmaceuticals Inc. (NASDAQ:AGIO) saw its shares fall about 25% on Monday following the publication of clinical results by Novo Nordisk for an experimental sickle cell disease therapy.
Novo Nordisk reported that its candidate, etavopivat, produced a 27% reduction in vaso-occlusive crisis events and delivered an approximately four-month delay to the first vaso-occlusive crisis event when added on top of standard of care in patients with sickle cell disease.
The announcement arrives as Agios continues discussions with the U.S. Food and Drug Administration to identify a path forward for its own sickle cell drug candidate, mitapivat, under an accelerated approval pathway. Agios is developing mitapivat as an experimental therapy for the same indication targeted by etavopivat.
Analysts reacted to the competing clinical readout. Truist analyst Gregory Renza, who keeps a buy rating on Agios, said the “competitor trial win for Etavopivat in SCD creates separation amongst PK class candidates.” Renza added that while Agios shares could face pressure from Novo’s data, “we believe the majority of the impact of the mix data has been baked into the stock at this point.” He further commented that “we come away still seeing a place for mitapivat in SCD given the high unmet need globally, and an opportunity for AGIO to leverage growing infrastructure and trust amongst the heme disease community.”
Stifel analyst James Condulis also weighed in, observing that “Etavopivat met its primary endpoints, which is surprising after AGIO’s setback.” Condulis said this development “is arguably most negative for AGIO’s AA (same MOA/failed ph3).”
Summary of the situation:
- Agios shares fell 25% following Novo Nordisk’s positive etavopivat data.
- Novo reported a 27% reduction in vaso-occlusive crisis events and an approximately four-month delay to first crisis when added to standard care.
- Agios is pursuing an accelerated approval pathway with the FDA for mitapivat, which targets the same indication.
The data from Novo has introduced a clearer competitive dynamic within the pharmacokinetic (PK) class of sickle cell therapies, according to the market commentary cited above. At the same time, some analysts continue to see a role for mitapivat given the stated high global unmet need and Agios’s ongoing engagement with regulatory authorities.