Yvonne Greenstreet, Alnylam CEO (Suzanne Kreiter/The Boston Globe via Getty Images)

Al­ny­lam her­alds PhI­II APOL­LO-B win on way to cre­at­ing an ‘in­dus­try lead­ing TTR fran­chise’

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 some 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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