Why biomarker confirmation is critical for clinical trial/real-world applicability, and if ACP-204 (remifanserin) would carry a black box warning like NUPLAZID.

Biomarker confirmation is critical to future-proof the program for regulatory success, as FDA is moving towards biomarker-confirmed Alzheimer's. It also helps ensure a more homogenous patient population. For the black box warning, ACADIA is collecting data to allow FDA to make a specific, data-based decision for remlifanserin, with good reason to believe it could avoid such a warning. “I fully anticipate by the time we would make it to FDA with our potential package for remlifanserin that there would be an expectation that Alzheimer's disease is a biologically confirmed disease. And so we've been -- we put this in place to try to future-proof the program that we have.”

What effect size on SAPS-H+D defines success, if there's an MCID, and how to differentiate remlifanserin from recently approved Alzheimer's agitation drugs.

ACADIA is powered for a 0.4 moderate effect size on SAPS-H+D, which would be considered successful. An MCID for SAPS-H+D is not yet well-established but will be defined. Remlifanserin targets psychosis, which can be a driver of agitation, but is distinct from other causes of agitation. There is ample room for multiple players in the Alzheimer's space. “We'll be pleased with an effect size that's in line with what we're powered for, which is a 0.4 or moderate effect size.”

Thoughts on filing remlifanserin based on a single placebo-controlled trial, and how gene therapy for Rett syndrome is factored into DAYBUE's $700M 2028 sales target.

The current base case for remlifanserin filing is two trials (Phase II and Phase III) due to safety database size, though striking Phase II results would prompt discussion with FDA. DAYBUE's $700 million 2028 sales target accounts for competitive dynamics, including gene therapy, as DAYBUE is expected to retain a role regardless of gene therapy availability. “Our base case assumption, which is that we need our Phase II and we need Phase III is going to be what we're going to need at the end of the day.”

ACAD

ACADIA (ACAD) Q1 FY26 earnings call: guidance and Q&A

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 6, 2026

Source: earnings call transcript

Executive summary

ACADIA Q1 FY26 — Strong DAYBUE Growth and Reaffirmed FY26 Guidance

ACADIA Pharmaceuticals delivered a solid Q1 FY26, driven by robust DAYBUE sales and the successful launch of DAYBUE STIX, while NUPLAZID demonstrated strong underlying demand despite temporary refill delays that have since normalized. The company reaffirmed its full-year guidance and highlighted significant pipeline catalysts, including the upcoming Phase II readout for remlifanserin in Alzheimer's disease psychosis and accelerated results for trofinetide in Japan, positioning ACADIA for continued growth.

Highlights

Total revenue reached $268 million in Q1 FY26, representing 11% year-over-year growth on an adjusted basis.
DAYBUE sales were $101 million, marking an impressive 20% year-over-year growth, the highest since Q3 2024.
The launch of DAYBUE STIX saw strong early uptake with over 250 prescriptions in Q1, nearly 30% of which were from treatment-naive or restarting patients.
NUPLAZID achieved approximately 11% year-over-year physician referral growth and 8% year-over-year demand growth, despite temporary refill delays.
The company reaffirmed its full year 2026 net sales guidance for both DAYBUE and NUPLAZID, and its total revenue guidance of $1.22 billion to $1.28 billion.

Concerns

NUPLAZID's Q1 performance was impacted by a temporary increase in patients taking longer than expected to refill prescriptions in January and early February.
SG&A expenses increased to $171 million in Q1 FY26 from $126.4 million in Q1 FY25, reflecting continued investments in commercial franchises and expanded field footprint.

Guidance & targets

Category	Target	Timeline	Confidence
Full Year Net Sales	Reaffirmed high materiality	FY26	High
Full Year Total Revenues	$1.22 billion to $1.28 billion high materiality	FY26	High
Remlifanserin Phase II Readout (ADP)	August to October 2026 high materiality	Q3-Q4 FY26	High
Trofinetide Japan Phase III Results	September to November 2026 medium materiality	Q3-Q4 FY26	High
NUPLAZID Annual Sales	approximately $1 billion high materiality	FY28	Medium
DAYBUE Annual Sales	$700 million high materiality	FY28	Medium
Pipeline Studies Initiation	5 additional Phase II or Phase III studies medium materiality	by end of 2027 · FY27	High
Pipeline Study Readouts	4 Phase II or Phase III study readouts medium materiality	by end of 2027 · FY27	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
DAYBUE Strong performance fueled by robust referral volumes, new patient starts, and reengagement of previously discontinued patients due to DAYBUE STIX launch. STIX uptake is quicker than anticipated, with significant interest from existing liquid formulation patients to switch. The Delphi expert consensus reinforces DAYBUE's position as standard of care for Rett syndrome. Unique patients receiving shipments: record quarterDAYBUE STIX prescriptions: >250 individual patientsDAYBUE STIX treatment-naive or restarting patients: nearly 30% of STIX patientsCaregiver satisfaction with STIX: >80% high satisfactionPersistency (liquid formulation) at 12 months: >55%Persistency (liquid formulation) at 18 months: ~50%Active patients on treatment for 12+ months: 74%Penetration within COEs: ~60%Penetration in the community: ~28%	$101 million	20%	—	—
NUPLAZID Q1 performance was impacted by temporary increase in patients taking longer to refill prescriptions, which has since normalized. Strong underlying demand and referral growth, even ahead of the anticipated impact from the sales force expansion. The company renewed its partnership with Ryan Reynolds for the unbranded 'More to Parkinson's' campaign. Physician referral growth: ~11% year-over-yearDemand growth: 8% year-over-yearGross to net adjustment: 22.1%Sales team expansion: 30% completed in Q1Target universe of HCPs: >10,000Awareness of hallucinations and delusions (Parkinson's community): increased from 8% to >30% (since campaign launch)Patients benefited over 10 years: nearly 100,000	$167 million	6% (adjusted)	—	—

Product announcements

Product	Type	Timeline	Details
DAYBUE STIX	launch	broadly available across the United States in early April

Deals & partnerships

Ryan Reynolds Renewed partnership for unbranded More to Parkinson's campaign.

Partnership for unbranded "More to Parkinson's" campaign, introducing new content and creative to raise awareness of Parkinson's disease psychosis.

Risks & headwinds

Temporary NUPLAZID refill delays January to early February

Impacted Q1 FY26 performance

Mitigation:Dynamics have since normalized; patients who were late to fill returned in the latter part of the quarter.

Increased SG&A expenses Q1 FY26

$171 million in Q1 FY26 vs $126.4 million in Q1 FY25

Mitigation:Reflects continued investments in commercial franchises with increased marketing and expanded field footprint for NUPLAZID and DAYBUE, which took place after Q1 FY25.

Potential for black box warning on remlifanserin Future regulatory approval

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Mitigation:Collecting data to allow FDA to make a specific decision on remlifanserin, aiming to potentially avoid such a warning.

Cross-study comparison challenges for remlifanserin Upcoming data readout

NPIC data not available for all patients in Phase II ADP study

Mitigation:NPIC is an exploratory endpoint with a subset of patients; caution advised in cross-study comparisons.

What to watch in Q2 FY26

Remlifanserin ADP Phase II readout

August to October 2026

Current Enrollment in final phases

Target Top-line results released

Why it matters

This represents the most significant near-term catalyst for the company with potential to unlock tremendous value in a market with no approved therapies.

First and foremost, we're approaching our highly anticipated top line results for remlifanserin in Alzheimer's disease psychosis, which we expect to report in the August to October time frame.

Find out whether ACAD delivers this. Inve re-checks your case every morning.

Q&A highlights

Seeking more precise enrollment status and data timelines for RADIANT (ADP) and ILLUMERA (LBD) studies.

Enrollment for the ADP program is in its final phases, confirming the August to October 2026 readout. Enrollment for the Lewy body dementia psychosis study is progressing well, but a public timeline for data is not yet available.

“The Alzheimer's study is still enrolling, and the enrollment dynamics continue to support our expectation for top line results in the August through October 2026 time frame.”

asked by Tessa Romero · answered by Elizabeth Thompson

3 min read 6 chapters

Detailed narrative

DAYBUE STIX Launch Success and Growth Outlook

The new powder formulation, DAYBUE STIX, launched successfully with strong early uptake, including over 250 prescriptions in Q1 FY26. Nearly 30% of these patients were treatment-naive or restarting therapy, aligning with expectations and supporting DAYBUE's growth outlook. Caregiver response has been particularly positive, with over 80% reporting high satisfaction, reinforcing the value of the new formulation in retaining current patients and growing the treated population.

The broader U.S. rollout in early April is expected to further accelerate this momentum.

NUPLAZID Commercial Dynamics and Expansion

NUPLAZID delivered $167 million in sales in Q1 FY26, reflecting 6% year-over-year growth on an adjusted basis. The quarter saw strong physician referral growth of approximately 11% and 8% demand growth, despite temporary refill delays in January and early February that have since normalized.

The company completed a 30% expansion of its sales team in Q1, increasing its target universe to over 10,000 HCPs, with the full impact of this productivity ramp expected by late 2026 and into next year, supporting the path towards approximately $1 billion in annual sales by 2028.

Remlifanserin ADP Program Progress and Readout

The Phase II RADIANT study for remlifanserin in Alzheimer's disease psychosis (ADP) is in its final phases of enrollment, with top-line results anticipated in August to October 2026. The study focuses on biomarker-confirmed Alzheimer's disease patients to future-proof the program and potentially improve technical and regulatory success.

Management aims for a 0.4 moderate effect size on SAPS-H+D, powered at 80%, and is collecting data to address potential black box warning concerns, aiming for a path forward without such a warning.

Trofinetide Japan Development and European Re-examination

Enrollment in the Phase III trial for trofinetide in Japan has accelerated, now expected to complete this quarter, with top-line results anticipated in September to November 2026. This small study is designed to provide descriptive information for Japanese patients, supporting a regulatory submission in 2027.

Concurrently, the trofinetide re-examination process in Europe remains ongoing, with conclusion expected by late June, as the company works with regulators to support the positive benefit-risk profile.

Pipeline Breadth and Long-Term Value Creation

ACADIA's pipeline includes 8 disclosed programs, with plans to initiate 5 additional Phase II or Phase III studies and report 4 readouts by the end of 2027. The company projects a combined full peak sales potential of $11 billion across its 4 molecules, with remlifanserin alone contributing $4 billion across ADP and Lewy body dementia psychosis indications.

This underscores the transformative potential of its R&D efforts and commitment to addressing significant unmet medical needs in neurological and rare diseases.

Financial Strength and Strategic Business Development

The company maintains a strong cash position of $851 million at the end of Q1 FY26, an increase from $820 million at the end of Q4 FY25, reflecting positive operating cash flow. This financial strength provides significant strategic flexibility to pursue business development opportunities, including potential acquisitions, licenses, and partnerships.

ACADIA is actively evaluating later-stage assets to complement its commercial franchises and refresh its early-stage pipeline, aiming for long-term value and growth.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.