Alnylam $ALNY has laid claim to a major success in Phase III, with its RNAi drug patisiran hitting the primary endpoint in its APOLLO-B study for ATTR amyloidosis with cardiomyopathy, one of the most important pivotal trials to read out this year.
Shares of the big biotech soared 46% ahead of the bell, after starting the day with a market cap of $17 billion.
This is a topline readout only, with no details on the precise data comparison for the primary endpoint of change from baseline in the 6-Minute Walk Test at 12 months compared to the placebo arm. That’s still a few weeks away, reserved for a conference. But the p-value hit 0.0162, while a key secondary on the quality of life also weighed in on the positive side of the stat boundary at 0.0397. And that sets the stage for a quick march to the FDA in search of a 2023 market launch.
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