Commercial PotentialClinicians may remain cautious about adding pelabresib to Jakafi until long-term safety is better understood, impacting commercial potential.
Regulatory ConcernsA warning letter was issued by the FDA to physicians involved in the MANIFEST-2 trial, raising concerns about the trial's outcomes and potential implications for the deal.
Safety IssuesThe rate of AML transformation in the pela + rux arm of the trial appears higher than in other studies and the disease's natural course, which could raise safety concerns.