ALNY - Is Alnylam's HELIOS-B Delay A Red Flag?

2024-03-10 00:54:52 ET

Summary

• Alnylam has pushed back the data readout for its HELIOS-B trial from early 2024 to June/July 2024, causing a 10% decline in the stock price.
• The company has made changes to the study duration, primary endpoint, and secondary endpoints of the trial, raising concerns among investors.
• The changes suggest that Alnylam may be facing challenges in achieving statistically significant results and demonstrating the superiority of its drug, vutrisiran, over the current front-line treatment for ATTR-CM, tafamidis.

Alnylam ( ALNY ) surprised investors with the announcement of pushing back the HELIOS-B data readout from early 2024 to June/July 2024. Analysts and investors were left trying to read the tea leaves of what this delay means for the odds of clinical success. It’s unusual for a Phase 3 trial endpoint to be abruptly changed at a time when investors were imminently expecting the data readout based on what the company stated just a few months prior. The uncertainty created a sizeable drop in the stock price. The question that needs to be answered is whether this change is a red flag or simply a smart move by management. This article will detail the changes being made in the trial and whether it warrants cause for concern....

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