Track market-moving stories before they get noisy

Key Takeaways Acadia received FDA Fast Track designation for remlifanserin in Alzheimer's disease psychosis. ACAD expects phase II top-line data between September and October 2026 as phase III enrollment continues. Acadia expects Nuplazid and Daybue combined net sales of about $1.7 billion by 2028. Acadia Pharmaceuticals (ACAD - Free Report) announced that the FDA has granted Fast Track designation to its investigational, highly selective, 5-HT2A receptor inverse agonist, remlifanserin, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).

The FDA’s Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fulfill unmet medical needs to get important new drugs to patients earlier. It offers benefits, such as more frequent FDA interactions, rolling submission of marketing applications and potential eligibility for Priority Review if certain conditions are met.

According to Acadia, there are currently no FDA-approved therapies for treating ADP.

More on ACAD’s RemlifanserinClinical Development ProgramAcadia is currently evaluating the safety and efficacy of remlifanserin in the RADIANT development program for the treatment of hallucinations and delusions associated with ADP. The company has completed enrollment in the phase II portion of the program and now expects to report top-line results between September and October 2026. Meanwhile, in line with the RADIANT program's seamless operational design, screening and patient enrollment are already underway for the phase III studies. In 2025, ACAD initiated another phase II study of remlifanserin for a second indication – Lewy Body Dementia with Psychosis.

Year to date, ACAD shares have lost 6% against the industry’s 2.4% growth.

Image Source: Zacks Investment Research

Apart from remlifanserin, Acadia’s clinical pipeline comprises several other candidates. The company, in partnership with Saniona, is gearing up to initiate a mid-stage study of ACP-711 for essential tremor in late 2026. In late 2025, ACAD initiated a mid-stage study of ACP-211 for the treatment of major depressive disorder. A first-in-human study of ACP-271 in healthy volunteers was also initiated in the first quarter of 2026.

ACAD's Marketed Drugs Expected to Aid GrowthAcadia’s long-term growth is supported by its lead product, Nuplazid and Daybue, in the United States. The company expects to generate around $1.7 billion in combined net sales by 2028, including $1 billion for Nuplazid and $700 million for Daybue.

Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. The drug enjoys patent protection in the United States until 2038, giving it a long runway for revenue generation by protecting against generic erosion. In the first quarter of 2026, Nuplazid recorded $167 million in sales, up 5% year over year, driven primarily by volume growth.

Since its U.S. launch in 2023 as the first and only treatment for Rett syndrome in adults and pediatric patients aged two years and older, Daybue has witnessed encouraging sales uptake. In the first quarter of 2026, Daybue recorded $101 million in sales, up 20% year over year, driven by growth in the drug’s unit sales as Acadia shipped it to more unique patients. A similar filing is also currently under regulatory review in the EU. A potential nod could further boost sales. Daybue is also marketed (and available) in Canada and Israel for the same indication.

In late 2025, the FDA approved Daybue Stix (trofinetide), a dye- and preservative-free powder formulation for the treatment of Rett syndrome in adults and pediatric patients aged two years and older. The new product expands the Daybue franchise, which remains the only FDA-approved treatment option for this indication.

Daybue Stix is now broadly available in the United States. The company will continue to offer the current oral solution alongside the new formulation, strengthening its positioning in the Rett syndrome treatment market.

ACAD's Zacks Rank & Stocks to ConsiderAcadia currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22% year to date.

Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.

Over the past 60 days, loss per share estimates for Amarin have narrowed from $6.36 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $4.64 to 51 cents for 2027. AMRN shares have lost 2.5% year to date.

Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have soared 123.5% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.

Key Takeaways ACAD up 6.8% after the CHMP recommended Daybu for EU approval in Rett syndrome following re-examination.Daybu could become the first EU-approved treatment for Rett syndrome's neurobehavioral symptoms.Acadia's phase III LAVENDER data supported the positive opinion after an earlier CHMP refusal. Acadia Pharmaceuticals (ACAD - Free Report) shares climbed 6.8% on Friday after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion following a re-examination procedure, recommending the approval of Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. The recommendation marks a major regulatory turnaround for the therapy, which could become the first approved treatment for this indication in the EU.

The positive CHMP recommendation represents an important milestone for Acadia as it seeks to expand Daybu's commercial footprint. Rett syndrome is a rare neurodevelopmental disorder with no therapies currently approved in the EU specifically for its neurobehavioral symptoms, leaving patients with limited treatment options. An approval would allow Acadia to address a significant unmet medical need while strengthening the long-term growth prospects of its rare disease franchise.

The CHMP's favorable opinion was primarily supported by data from the pivotal phase III LAVENDER study, which demonstrated statistically significant and clinically meaningful improvements in key measures of Rett syndrome. The study met its co-primary endpoints, showing benefits on the Rett Syndrome Behavior Questionnaire and the Clinical Global Impression-Improvement scale, indicating that Daybu can improve some of the core neurobehavioral manifestations of the disease that substantially affect patients' daily functioning and caregiver burden.

Following the CHMP recommendation, the European Commission (EC) will review the agency's opinion before issuing a final regulatory decision, which is expected in the coming months. If approved, Daybu's centralized marketing authorization would be valid across all 27 EU member states as well as Iceland, Liechtenstein and Norway, significantly expanding access to the therapy across Europe.

The FDA approved trofinetide as the first and only treatment for Rett syndrome in adults and pediatric patients aged two years and older in 2023. The drug is marketed under the brand name Daybue in the United States. Daybue is also marketed (and available) in Canada and Israel for the same indication.

Year to date, Acadia shares have lost 5.2% against the industry’s 5.2% growth.

Image Source: Zacks Investment Research

Earlier CHMP Refusal Delayed EU Expansion of ACAD’s DaybuThe latest recommendation follows a significant regulatory setback earlier this year, when the CHMP formally adopted a negative opinion recommending against the approval of trofinetide for the treatment of Rett syndrome in patients aged two years and older in the EU. The decision came after the committee had previously notified Acadia of a negative trend vote on the marketing application in early February, prompting the company to seek a formal re-examination of the application.

Although the pivotal LAVENDER study had achieved its co-primary and key secondary endpoints, the CHMP had previously concluded that several aspects of the evidence package limited its ability to support approval. The committee viewed the treatment benefit observed after 12 weeks as modest, questioned whether the study adequately captured all core symptoms of Rett syndrome and expressed concerns that patient discontinuations may have affected the interpretation of longer-term outcomes.

Following the initial refusal, Acadia reviewed the CHMP's objections in detail and proceeded with the re-examination process, ultimately securing the positive recommendation now under consideration by the EC. The favorable outcome substantially improves the therapy's regulatory outlook in Europe and revives the company's efforts to bring Daybu to patients across the region.

ACAD's Marketed Drugs Expected to Aid GrowthAcadia’s long-term growth is supported by its lead product, Nuplazid and Daybue in the United States. The company expects to generate around $1.7 billion in combined net sales by 2028, including $1 billion for Nuplazid and $700 million for Daybue.

Nuplazid is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis in the United States. The drug enjoys patent protection in the United States until 2038, which gives it a long runway for revenue generation by protecting against generic erosion. In the first quarter of 2026, Nuplazid recorded $167 million in sales, up 5% year over year, driven primarily by volume growth.

Since its launch in 2023, Daybue has witnessed encouraging sales uptake. In the first quarter of 2026, Daybue recorded $101 million in sales, up 20% year over year, driven by growth in the drug’s unit sales as Acadia shipped it to more unique patients. A potential EU approval could further boost sales.

In late 2025, the FDA approved Daybue Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation for the treatment of Rett syndrome in adults and pediatric patients aged two years and older. The new product expands the Daybue franchise, which remains the only FDA-approved treatment option for this indication.

Per Acadia, the full U.S. launch of Daybue STIX is underway, with nearly 30% of patients using STIX either new to treatment or resuming therapy after previously discontinuing the liquid formulation. The company will continue to offer both formulations in the United States, strengthening its positioning in the Rett syndrome treatment market.

ACAD's Zacks Rank & Stocks to ConsiderAcadia currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 126.7% year to date.

Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.34 to $4.05. Over the same period, EPS estimates for 2027 have risen to $4.27 from $3.56. INDV shares have gained 16.6% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.

The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 11% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.