Clinical TrialsAadi announced the discontinuation of nab-sirolimus' tumor agnostic and registration-directed PRECISION1 study.
Market RisksRisks include: disappointing market uptake of FYARRO in the PEComa indication, inability to develop FYARRO in other cancers, failure of FYARRO to achieve commercial success due to market size, penetration rate, or competition, and potential medium- to long-term dilution risk.
Regulatory ChallengesIDMC analysis showed the pivotal Ph2 tumor agnostic study of nab-sirolimus in TSC1/TSC2 was unlikely to exceed efficacy threshold for accelerated approval.