Competitive PressureThe ongoing debate on the scope of a potential REMS program for aficamten vis à vis that for BMY’s Camzyos is likely to keep the stock range bound over the near term.
Regulatory ChallengesSpecialty drugs like Afi will likely not be on formulary, requiring more diligence for approval via Medical Exemption.
Safety ConcernsSafety was more problematic, where beyond high rates of GI issues, one patient’s LVEF dropped below 50%, raising the prospect of a potential REMS with negative commercial read-throughs.