Acadia Pharmaceuticals Announces DAYBUE® STIX (trofinetide) is Now Broadly Available in the United States for the Treatment of Rett Syndrome

SAN DIEGO--(BUSINESS WIRE)--Apr 7, 2026--

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced DAYBUE ® STIX (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide, is now broadly available in the United States for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. The new formulation, approved by the U.S. Food and Drug Administration (FDA) in December 2025, is bioequivalent to the original DAYBUE ® oral solution, delivering the same efficacy and safety profile, while offering children and adults living with Rett syndrome new flexibility and choice regarding the dose volume and taste of their DAYBUE treatment. 1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260407618433/en/

"Initial feedback from a small group of caregivers following the limited launch revealed that more than 80% of early users reported satisfaction with DAYBUE STIX, highlighting the added flexibility and portability of this new formulation," 2 said Tom Garner, Acadia’s Chief Commercial Officer. “We are hearing that the new formulation may allow for more customized care in real-world settings. Ongoing evaluation from patients and caregivers remains a priority; their perspectives are essential as we identify ways to better assist families managing this complex condition.”

The importance of flexible, patient-centered approaches was reinforced in a recent publication of expert recommendations for real-world use of trofinetide in Rett syndrome. A steering group comprised of experts based at International Rett Syndrome Foundation (IRSF)-designated centers of excellence (COEs) reached consensus recognizing trofinetide oral solution as part of the standard of care for individuals with Rett syndrome. They also aligned on key real-world considerations such as early initiation and sustained use over time. The recommendations also reflect shared perspectives on the need for individualized decision making in clinical practice to help optimize outcomes for patients, families, and caregivers. 3

“The availability of DAYBUE STIX gives us an additional, flexible way to administer trofinetide, which allows us more options to address unique patient and caregiver needs,” said Arthur Beisang, M.D., Department of Pediatrics, Gillette Children's Specialty Healthcare, Saint Paul, Minn. “This patient-centered approach aligns with recently published expert consensus recommendations, which advocate for the integration of trofinetide as part of the standard of care and comprehensive Rett syndrome management. This new option provides additional customization, supporting individualized care for people with Rett syndrome.”

DAYBUE STIX is a for oral solution powder that caregivers can mix with a variety of water-based liquids such as juice, tea, lemonade, limeade, or liquid hydration so that caregivers have the ability to customize to their loved ones' taste. 4 The product comes in individual packets that are easily portable.

The efficacy and safety of DAYBUE STIX is based on the results of the pivotal Phase 3 LAVENDER™ study with DAYBUE oral solution in patients with Rett syndrome. 4 The approval of this new formulation was informed by the results of a bioequivalence study, which demonstrated that both original DAYBUE oral solution and the new DAYBUE STIX for oral solution powder formulation provide comparable exposure. 1

Families interested in exploring this new option should speak with their healthcare provider. Acadia also offers families access to Acadia Connect®, a multi-faceted support program that offers a dedicated, experienced support team assisting with financial resources and prescription support to patients and caregivers throughout the DAYBUE treatment journey. The original oral solution formulation approved by the U.S. Food and Drug Administration in 2023 will remain available.

About Rett Syndrome

Rett syndrome is a rare, complex, neurodevelopmental disorder that may occur over four stages and occurs in approximately one of every 10,000 to 15,000 female births worldwide. 5-7 In the U.S., 6,000 to 9,000 patients are affected. 8 A child with Rett syndrome exhibits an early period of apparently normal development until six to 18 months, when their skills seem to slow down or stagnate. This is typically followed by a duration of regression when the child loses acquired communication skills and purposeful hand use. The child may then experience a plateau period in which they show mild recovery in cognitive interests, but body movements remain severely diminished. As they age, those living with Rett may continue to experience a stage of motor deterioration, which can last the rest of the patient’s life. 6 Rett syndrome is typically caused by a genetic mutation on the MECP2 gene. 9 In preclinical studies, deficiency in MeCP2 function is thought to lead to impairment in synaptic communication, and the deficits in synaptic function may be associated with Rett manifestations. 9-11

Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. 12 Most Rett patients typically live into adulthood and require round-the-clock care. 5,13

About DAYBUE ® (trofinetide) and DAYBUE ® STIX (trofinetide)

Trofinetide is a synthetic analog of the N-terminal tripeptide of insulin-like growth factor-1. The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. In animal studies, trofinetide has been shown to increase branching of dendrites and synaptic plasticity signals. 14

Indication and Important Safety Information for DAYBUE ® (trofinetide) and DAYBUE ® STIX (trofinetide)

Indication

DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.

Important Safety Information

DAYBUE is available as an oral solution (200 mg/mL).

DAYBUE STIX for oral solution powder is available in 5,000 mg, 6,000 mg, and 8,000 mg packets.

Please read the full Prescribing Information also available at DAYBUEhcp.com.

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “expects,” “anticipates,” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) the efficacy and safety profile of DAYBUE and DAYBUE STIX and anticipated Rett syndrome symptom improvements, (ii) the flexibility in administration and allowance for customized care provided by DAYBUE STIX, (iii) the use of DAYBUE and DAYBUE STIX as the standard of care for patients with Rett syndrome and (iv) potential future use of DAYBUE and DAYBUE STIX. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties, assumptions and other factors include, but are not limited to: our ability to continue to successfully commercialize DAYBUE and DAYBUE STIX and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on February 26, 2026, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.

References

 

Acadia Pharmaceuticals Announces DAYBUE® STIX (trofinetide) is Now Broadly Available in the United States for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Announces DAYBUE® STIX (trofinetide) is Now Broadly Available in the United States for the Treatment of Rett Syndrome

LONDON (AP) — The rapper formerly known as Kanye West has been barred from entering the U.K., where he was scheduled to perform at the Wireless Festival in July.

It came after government officials condemned Ye's history of antisemitic remarks.

The festival’s organizers confirmed the ban and said the entire three-day festival was being canceled as a result.

Ye’s travel authorization had been blocked on the grounds that the performer’s presence in the U.K. would not be “conducive to the public good," the BBC said, citing the Home Office.

Ye was booked to perform in front of around 150,000 revelers July 10-12 at the open-air festival in London’s Finsbury Park.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

LONDON (AP) — A senior member of the British government said Tuesday that Ye should “absolutely not” play the Wireless Festival as the performer offered to meet members of the U.K.’s Jewish community and show he has changed since provoking outrage with antisemitic statements.

U.K. authorities are considering whether to ban the rapper formerly known as Kanye West from entering Britain, where he is booked to perform in front of around 150,000 revelers July 10-12 at the open-air festival in London’s Finsbury Park.

“His permission to enter the U.K. is under review as we speak," said Prime Minister Keir Starmer's spokesman, Tom Wells. “All options remain on the table.”

Organizers are under mounting pressure from sponsors and politicians to cancel the gigs by the rapper, who has drawn widespread condemnation for making antisemitic remarks and voicing admiration for Adolf Hitler.

Last year, he released a song called “Heil Hitler” and advertised a swastika T-shirt for sale on his website. The 48-year-old apologized in January with a letter, published as a full-page advertisement in The Wall Street Journal. He said his bipolar disorder led him to fall into “a four-month long, manic episode of psychotic, paranoid and impulsive behavior that destroyed my life.”

Wireless sponsors Pepsi, Rockstar Energy and Diageo have pulled out of the festival since Ye was announced as the headliner, and Starmer called the booking “deeply concerning.”

In a statement Tuesday, Ye, who changed his name in 2021, said he “would be grateful for the opportunity to meet with members of the Jewish community in the U.K. in person, to listen.

“I know words aren’t enough — I’ll have to show change through my actions,” he said. “If you’re open, I’m here.”

Phil Rosenberg, president of the Board of Deputies of British Jews, said the group would be willing to meet with the musician if he pulled out of the festival.

“The Jewish community will want to see a genuine remorse and change before believing that the appropriate place to test this sincerity is on the main stage at the Wireless Festival,” Rosenberg said.

Organizer Festival Republic stood by Ye. In a statement issued Monday, managing director Melvin Benn urged people to offer the performer “forgiveness and hope.”

“We are not giving him a platform to extol opinion of whatever nature, only to perform the songs that are currently played on the radio stations in our country and the streaming platforms in our country and listened to and enjoyed by millions,” the statement said.

U.K. Health Secretary Wes Streeting dismissed the organizers’ statement as “absurd” and said Ye should “absolutely not” perform at Wireless.

Benn acknowledged that Home Secretary Shabana Mahmood had the power to revoke Ye's visa to come to Britain.

“If she does, she does, and then the issue is over,” he told the BBC on Tuesday.

A representative for Ye didn’t reply to a request for comment.

FILE - Kanye West appears at the 67th annual Grammy Awards in Los Angeles on Feb. 2, 2025. (Photo by Jordan Strauss/Invision/AP, File)

FILE - Kanye West, who changed his name to Ye in 2021, performs at the Coachella Music & Arts Festival in Indio, Calif., on April 20, 2019. . (Photo by Amy Harris/Invision/AP, File)