just saw acadia got hit with a negative opinion from the EU regulator on daybue for rett syndrome treatment. rough timing since the drug's actually doing pretty well in the us market. first nine months of 2025 they pulled in $281.8m in sales, up 12% year over year. but yeah, the european medicines agency basically said no to the marketing application, so that approval's getting pushed back significantly.

what's interesting though is they're still bullish on the us side. the company's expecting combined net sales of around $1.7b by 2028 across their portfolio - $1b from nuplazid and $700m from daybue. plus they just got fda approval for daybue stix, a new powder formulation, and they're launching it in q1 2026 with broader rollout coming in q2. so the rett syndrome news isn't all bad if you're looking at their domestic pipeline.

nuplazid's the real money maker though - $505.7m in sales for the first nine months of 2025, up 13% yoy. patent protection until 2038 means they've got a long runway before generics show up. acadia's ranked hold right now, but if they can navigate the eu situation and keep momentum in the us, there's still upside here. anyone else watching this rett syndrome news closely or is the eu setback too much of a headwind?