Alnylam tweaks endpoints to help vutrisiran compete in ATTR-CM

Alnylam is making changes to its ongoing Phase III trial of vutrisiran that could affect the drug’s labeling if approved for ATTR with cardiomyopathy — an important indication for the company. The new goal is to show strong monotherapy activity, as the company suspects payers to push back on covering combinations. 

The Phase III HELIOS-B study was set to read out early this year, but changes to the statistical analysis plan, announced Thursday, have pushed the data into late June or early July. The delay, and what the changes may reflect about the commercial potential of the product, sent shares of Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) down $16.72 (10%) representing a loss in market cap of over $2 billion. ...