Agios shares drop after report notes deaths of Pyrukynd patients

Investing.com -- Agios Pharmaceuticals stock is falling 15% in premarket trading Monday after the FDA’s Adverse Events Reporting System added three deaths in patients taking Pyrukynd in July.

According to Leerink analyst Andrew Berens, who maintains a market perform rating, case information obtained through a Freedom of Information Act request revealed that "two of the recent deaths were in young patients."

Berens noted both new cases listed "hypertransaminasaemia" as one of the preferred terms, which is an adverse event of interest "since the company disclosed the risk of hepatocellular injury during ASH 2024."

The third case appears less concerning as transaminase elevations were not mentioned, and the patient was 93 years old, Berens added.

Agios management has indicated "these new entries were not material changes to the known profile of mitapivat and had already been addressed in the recent label revisions," according to the analyst.

Since Pyrukynd’s launch, four deaths while on the drug have appeared in the FAERS database.

Berens expects volatility ahead of the September 7 Pdufa date for thalassemia and the subsequent sickle cell program.

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