We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Acadia's Daybue Patent Allowance Extends U.S. Protection to March 2041
Read MoreHide Full Article
Key Takeaways
Acadia secured a Notice of Allowance that could extend Daybue patent protection to March 2041.
ACAD's Daybue sales rose 25% to $226 million in the first half of 2026.
Trofinetide's EU approval for Rett syndrome expanded its commercial reach beyond the United States and Canada.
Acadia Pharmaceuticals (ACAD - Free Report) has strengthened the intellectual property protection surrounding trofinetide, marketed in the United States as Daybue, following a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO). The allowance covers weight-banded dosing of trofinetide for Rett syndrome and is expected to extend U.S. patent protection from July 2036 to March 28, 2041, subject to issuance of the patent and six months of pediatric exclusivity.
The Notice of Allowance applies to U.S. Patent Application No. 17/590,496, titled “Methods and Compositions for Treatment of Rett Syndrome.” Per Acadia, the USPTO has determined that the application meets the requirements for patentability. The patent is expected to issue after completion of standard administrative steps. The application specifically covers weight-banded dosing of trofinetide, a regimen used for ACAD’s marketed Daybue and Daybue STIX formulations.
The newly allowed patent would add to an existing U.S. method-of-use patent covering trofinetide for the treatment of Rett syndrome, which expires in July 2036. The new protection would therefore extend the period during which Acadia expects to have patent coverage for trofinetide in the United States by almost five years. The allowance is particularly relevant because it covers a dosing regimen incorporated into the marketed products, providing an additional intellectual property layer around the franchise.
Year to date, ACAD shares have lost 23.1% against the industry’s 7.3% growth.
Image Source: Zacks Investment Research
For Acadia, the additional patent protection could help preserve the commercial opportunity for Daybue by potentially delaying generic competition involving the covered weight-banded dosing regimen. Longer patent coverage can also provide greater visibility into the product’s revenue-generating period and support the company’s efforts to maximize the value of trofinetide. However, the allowance does not represent a blanket extension of every patent right associated with trofinetide, making the scope of the specific claims important to the overall exclusivity profile.
ACAD’s Daybue Gains Growth Momentum With Global Expansion
Acadia’s Daybue is the first and only therapy specifically approved by the FDA for Rett syndrome. The FDA approved it in March 2023 for adults and pediatric patients two years of age and older. In December 2025, the FDA approved Daybue STIX, a dye- and preservative-free powder formulation of trofinetide for oral solution, for the same patient population. Unlike the original Daybue oral solution, STIX provides an alternative powder format and greater flexibility regarding dose volume and taste. Acadia made Daybue STIX broadly available in the United States in April 2026.
Acadia reported Daybue net product sales of about $226 million in the first half of 2026, representing growth of approximately 25%. The uptick was primarily driven by continued patient demand and strong uptake of Daybue STIX.
The product also secured an important regulatory milestone in Europe. In August 2026, the European Commission granted marketing authorization for Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. Acadia said the authorization makes Daybu the first and only treatment approved for Rett syndrome in the EU, expanding trofinetide’s commercial reach beyond the United States and Canada.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have increased 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 16.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 77.6% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
Image: Bigstock
Acadia's Daybue Patent Allowance Extends U.S. Protection to March 2041
Key Takeaways
Acadia Pharmaceuticals (ACAD - Free Report) has strengthened the intellectual property protection surrounding trofinetide, marketed in the United States as Daybue, following a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO). The allowance covers weight-banded dosing of trofinetide for Rett syndrome and is expected to extend U.S. patent protection from July 2036 to March 28, 2041, subject to issuance of the patent and six months of pediatric exclusivity.
The Notice of Allowance applies to U.S. Patent Application No. 17/590,496, titled “Methods and Compositions for Treatment of Rett Syndrome.” Per Acadia, the USPTO has determined that the application meets the requirements for patentability. The patent is expected to issue after completion of standard administrative steps. The application specifically covers weight-banded dosing of trofinetide, a regimen used for ACAD’s marketed Daybue and Daybue STIX formulations.
The newly allowed patent would add to an existing U.S. method-of-use patent covering trofinetide for the treatment of Rett syndrome, which expires in July 2036. The new protection would therefore extend the period during which Acadia expects to have patent coverage for trofinetide in the United States by almost five years. The allowance is particularly relevant because it covers a dosing regimen incorporated into the marketed products, providing an additional intellectual property layer around the franchise.
Year to date, ACAD shares have lost 23.1% against the industry’s 7.3% growth.
Image Source: Zacks Investment Research
For Acadia, the additional patent protection could help preserve the commercial opportunity for Daybue by potentially delaying generic competition involving the covered weight-banded dosing regimen. Longer patent coverage can also provide greater visibility into the product’s revenue-generating period and support the company’s efforts to maximize the value of trofinetide. However, the allowance does not represent a blanket extension of every patent right associated with trofinetide, making the scope of the specific claims important to the overall exclusivity profile.
ACAD’s Daybue Gains Growth Momentum With Global Expansion
Acadia’s Daybue is the first and only therapy specifically approved by the FDA for Rett syndrome. The FDA approved it in March 2023 for adults and pediatric patients two years of age and older. In December 2025, the FDA approved Daybue STIX, a dye- and preservative-free powder formulation of trofinetide for oral solution, for the same patient population. Unlike the original Daybue oral solution, STIX provides an alternative powder format and greater flexibility regarding dose volume and taste. Acadia made Daybue STIX broadly available in the United States in April 2026.
Acadia reported Daybue net product sales of about $226 million in the first half of 2026, representing growth of approximately 25%. The uptick was primarily driven by continued patient demand and strong uptake of Daybue STIX.
The product also secured an important regulatory milestone in Europe. In August 2026, the European Commission granted marketing authorization for Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. Acadia said the authorization makes Daybu the first and only treatment approved for Rett syndrome in the EU, expanding trofinetide’s commercial reach beyond the United States and Canada.
ACADIA Pharmaceuticals Inc. Price and Consensus
ACADIA Pharmaceuticals Inc. price-consensus-chart | ACADIA Pharmaceuticals Inc. Quote
ACAD's Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have increased 86.9% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 16.9% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 77.6% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.