Agios Pharmaceuticals stock declined 15% in premarket trading Monday following new entries in the FDA’s Adverse Events Reporting System (FAERS) documenting three deaths in patients treated with Pyrukynd in July.
Leerink analyst Andrew Berens, who maintains a market perform rating on Agios, noted that information obtained via a Freedom of Information Act request revealed “two of the recent deaths were in young patients.”
Berens pointed out that both of these cases listed “hypertransaminasaemia” among the preferred terms, an adverse event of concern “since the company disclosed the risk of hepatocellular injury during ASH 2024.”
The third case, involving a 93-year-old patient, appeared less alarming as there were no mentions of transaminase elevations, Berens added.
According to the analyst, Agios management has indicated that “these new entries were not material changes to the known profile of mitapivat and had already been addressed in the recent label revisions.”
Since Pyrukynd’s market introduction, four deaths related to the drug have been reported in the FAERS database.
Berens anticipates increased volatility in the lead-up to the September 7 PDUFA date for the thalassemia indication and the subsequent sickle cell program.
Agios Pharmaceuticals stock price
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