Alnylam stock tumbled Thursday after a split advisory panel recommended that the Food and Drug Administration approve its heart disease treatment.
The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3, saying the benefits of Alnylam Pharmaceuticals' (ALNY) drug, Onpattro, outweigh the risks for patients with transthyretin amyloid cardiomyopathy. In this condition, abnormal plaque called amyloid builds up on the heart. This can lead to heart failure.
But panelists suggested Onpattro would only be useful for patients who worsen while receiving Pfizer's (PFE) tafamidis, which sells as Vyndaqel and Vyndamax. Patients treated with Onpattro showed improvements in symptoms. But Pfizer's drug has a proven benefit on mortality.
RBC Capital Markets analyst Luca Issi remained upbeat, despite the tumble for Alnylam stock.
"The vote is nonbinding, but we think approval on Oct. 8 is likely at this point," he said in a note.
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