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ACADIA Pharmaceuticals (ACAD) gets 'sell' rating on weak trial results, shares fall 13%. Published September 24, 2026 at 11:26 pm EDT ACADIA Pharmaceuticals (NASDAQ:ACAD) fell for a fifth consecutive day on Thursday, shedding 12.78 percent to close at $22.18 apiece, after earning a sell recommendation from Goldman Sachs. In its market note, the investment firm reiterated its sell recommendation and $17 price target on the stock after missing its primary endpoint in its phase 2 study of 5-HT2A inverse agonist remlifanserin for the treatment of hallucinations and delusions in patients with Alzheimer's disease psychosis. The price target marked a 23 percent discount from its latest closing price. The clinical study will still progress to its third phase, but the company will be inclined to remove the 30 mg dosage arm due to the lack of improvement in its efficacy during the recently concluded trial. ACADIA Pharmaceuticals said that it plans to present detailed safety and efficacy results from the Phase 2 study in an oral presentation at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston on November 16 to 19, 2026. Additionally, remlifanserin is currently being investigated in an additional Phase 2 study to evaluate its efficacy, safety, and tolerability for the treatment of Lewy body dementia psychosis. Citi, BMO Capital maintain positive ratings. In contrast, Citigroup maintained its buy recommendation on the stock, albeit it lowered its price target to $33 from $40 previously. The reduction was also triggered by the missed primary endpoint. For its part, BMO Capital slashed its price target for the firm to $34 while maintaining an outperform rating, also amid expectations for the drug candidate's reduced probability of success to just 35 percent from 40 percent prior. BMO Capital noted that the phase 2 study trial miss represents a near-term headwind for ACADIA Pharmaceuticals, although it noted that clear response, consistency of SAPS-H+D improvements over time, and stronger efficacy in higher psychosis burden patients all suggest that the treatment candidate is therapeutically active in Alzheimer's disease psychosis. The firm said remlifanserin retains potential to show success in both Alzheimer's disease psychosis and Lewy body dementia psychosis. Strong hedge fund conviction. In terms of institutional sentiment, ACADIA Pharmaceuticals earned a strong backing from hedge fund holders, as evidenced by the jump in their committed capital, even as one fund exited its position. Data from Insider Monkey showed that 38 hedge funds held positions in the stock in the second quarter of the year, down from 39 in the quarter previously. However, the existing investors' combined holdings increased by 13.67 percent to $1.58 billion from $1.39 billion quarter-on-quarter. As the data predate phase 2 trial results, updated hedge fund holdings in the third quarter of the year will offer critical insight on whether the high-conviction buying trend persisted.

Acadia advances remlifanserin program after Phase 2 Alzheimer's trial results

Neuren secures European approval for Rett syndrome treatment. Neuren Pharmaceuticals has reached a major milestone in the global commercialisation of trofinetide after the European Commission granted marketing authorisation for DAYBU to treat neurobehavioural symptoms associated with Rett syndrome. The approval makes DAYBU the first and only authorised treatment for Rett syndrome in the European Union, extending access to patients aged five years and older across all 27 EU member states as well as Iceland, Liechtenstein and Norway. For the Melbourne-based biotechnology company, the decision represents both an important advance for families affected by the rare neurological disorder and a potentially material commercial catalyst under its licensing arrangement with Acadia Pharmaceuticals. Acadia, which holds Neuren's exclusive worldwide licence to develop and commercialise trofinetide, has previously indicated that it expects to launch DAYBU in Germany in early in the fourth quarter of 2026. Neuren chief executive Jon Pilcher said the approval was especially meaningful given the absence of an approved Rett syndrome treatment in Europe until now. "We are delighted for the Rett syndrome community in Europe, who, until now, have had no approved treatment for this devastating condition," Pilcher said. "The European Commission's approval of DAYBU is particularly rewarding for Neuren given our long-standing commitment to developing therapies for serious neurological disorders with profound unmet need." Rett syndrome is a severe genetic neurodevelopmental condition that predominantly affects girls and can lead to profound impairments in communication, motor function and everyday functioning. The European approval allows DAYBU to be marketed for the treatment of its neurobehavioural symptoms, creating a new treatment option for patients and families across the region. The decision also brings financial significance for Neuren. Under its European licence agreement with Acadia, Neuren is entitled to receive US$35 million following the first commercial sale of DAYBU in Europe. It could also receive up to US$170 million in sales milestone payments as annual net sales reach escalating thresholds, alongside tiered royalties ranging from the mid-teens to the low 20 per cent range. DAYBUE oral solution is already approved for Rett syndrome in the United States, Canada and Israel, while DAYBUE STIX powder has been approved by the US Food and Drug Administration. Trofinetide is not approved for sale in Australia. The European authorisation comes as Neuren continues to advance its broader pipeline of therapies for serious neurological disorders. Its investigational candidate NNZ-2591, also known as ercanetide, is in clinical development for several rare neurodevelopmental conditions, including Phelan-McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome. Neuren is also developing NNZ-2591 for hypoxic ischaemic encephalopathy, a form of brain injury that can occur before or shortly after birth. The company is currently running its Phase 3 Koala trial, a randomised, double blind and placebo-controlled study assessing NNZ-2591 in children aged three to 12 years with Phelan-McDermid syndrome, alongside a 52-week open-label extension study.