What changed in this filing

/stocks — the workspaceLOADING

Item 1. Legal Proceedings

2026-08-05 compared with 2026-05-07 · 75 added, 54 removed, 1093 unchanged (11% of the section changed)

11 unchanged sentences

To the extent we cannot establish, maintain or increase sales of our products, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline.

• Our products may not gain maximal acceptance among physicians, patients, caregivers and the medical community, thereby limiting our potential to generate revenues.

• Our products and product candidates, if approved, may not gain maximal acceptance among physicians, patients, caregivers and the medical community, and our projections regarding the market opportunities for our products and product candidates may not be accurate, thereby limiting our potential to generate revenues.

• Our ability to generate product revenues will be diminished if coverage for our products from commercial or government payors is not provided, is decreased or if patients have unacceptably high out-of-pocket requirements.

3 unchanged sentences

• Drug development is a long, expensive and unpredictable process with a high risk of failure, and there is no guarantee that our products or product candidates will be successful in ongoing or future clinical trials or obtain regulatory approval.

• The regulatory approval processes in the European Union (EU) and outside North America are lengthy, time consuming and inherently unpredictable, and, if we do not obtain regulatory approval of trofinetide outside North America, we will not be able to market trofinetide outside North America, which will limit our trofinetide commercial revenues.

• The regulatory approval processes in the EU and outside North America are lengthy, time consuming and inherently unpredictable, and, if we do not obtain regulatory approval of trofinetide outside North America, we will not be able to market trofinetide outside North America, which will limit our trofinetide commercial revenues.

• Expanded access or compassionate use programs could subject us to additional risks.

17 unchanged sentences

We have two products that are approved for commercialization in the U.S.:

NUPLAZID and DAYBUE.

We have NUPLAZID and DAYBUE products, including DAYBUE and DAYBUE STIX, that are approved for commercialization in the U.S.

The successful commercialization of such products is subject to many risks, and there is no guarantee that we will be able to maintain or increase sales of such products.

9 unchanged sentences

• any negative publicity related to our products.

Additionally, our success is dependent on our ability to obtain regulatory approval for, and successfully commercialize, trofinetide in jurisdictions outside the U.S., including the EU.

Additionally, our success is dependent on our ability to obtain regulatory approval for, and successfully commercialize, trofinetide in jurisdictions outside the U.S., including DAYBU in the EU.

We will face in jurisdictions outside the U.S., such as the EU, if approved for marketing, risks and uncertainties similar to the risks and uncertainties faced in the U.S.

1 unchanged sentence

If the commercialization of our products and future sales is less successful than expected or perceived as disappointing, our stock price could decline significantly and the long-term success of our products and our company could be harmed.

Our products may not gain maximal acceptance among physicians, patients, caregivers and the medical community, thereby limiting our potential to generate revenues.

The degree of market acceptance by physicians, healthcare professionals, patients, caregivers and third-party payors of our products, and our profitability and growth, will depend on a number of factors, including:

Our products and product candidates, if approved, may not gain maximal acceptance among physicians, patients, caregivers and the medical community, and our projections regarding the market opportunities for our products and product candidates may not be accurate, thereby limiting our potential to generate revenues.*

The degree of market acceptance by physicians, healthcare professionals, patients, caregivers and third-party payors of our products and product candidates, if approved, and our profitability and growth, will depend on a number of factors, including:

• the ability to provide acceptable evidence of safety and efficacy;

• the scope of the approved indication(s) for the product;

• the scope of the approved indication(s);

• the inclusion of any warnings or contraindications in the product label;

7 unchanged sentences

• effectiveness of our or our collaborators’ sales and marketing strategy;

• publicity concerning us, our products or competing products and treatments;

• publicity concerning us, our products and product candidates or competing products and treatments;

• our ability to obtain and maintain sufficient third-party insurance coverage or adequate reimbursement levels.

If a product does not provide a treatment regimen that is at least as beneficial as the current standard of care or otherwise does not provide patient benefit, that product will not achieve market acceptance and will not generate sufficient revenues to achieve or maintain profitability.

With respect to our products specifically, successful commercialization will depend on whether and to what extent physicians, patients, caregivers, long-term care facilities and pharmacies, over whom we have no control, determine to utilize our products.

If a product or product candidate does not provide a treatment regimen that is at least as beneficial as the current standard of care or otherwise does not provide patient benefit, that product or product candidate will not achieve market acceptance and will not generate sufficient revenues to achieve or maintain profitability.

With respect to our approved products specifically, successful commercialization will depend on whether and to what extent physicians, patients, caregivers, long-term care facilities and pharmacies, over whom we have no control, determine to utilize our products.

NUPLAZID is available in the U.S.

to treat hallucinations and delusions associated with PDP, and DAYBUE is available in the U.S.

to treat hallucinations and delusions associated with PDP, and DAYBUE products are available in the U.S.

to treat Rett syndrome, both indications for which no other FDA-approved pharmaceutical treatments currently exist.

DAYBUE is also the first and only product approved in Canada and Israel for the treatment of Rett syndrome.

As there are no approved competitors for our products, it is particularly difficult to estimate the market potential for our products and how physicians, patients, caregivers, long-term care facilities and payors will respond to changes in the price of our products.

Industry sources and analysts have a divergence of estimates for the near- and long-term market potential of our products, and a variety of assumptions directly impact the estimates for our products’ market potential, including assumptions regarding the prevalence of PDP and Rett syndrome, the rate of diagnosis of PDP and Rett syndrome, the prevalence and rate of hallucinations and delusions in patients diagnosed with PDP with respect to NUPLAZID, the rate of physician adoption, the potential impact of payor restrictions, and patient adherence and compliance rates.

Small differences in these assumptions can lead to widely divergent estimates of the market potential of our products.

Further, our projections regarding the market opportunities for our products and product candidates are subject to several assumptions and estimates.

These assumptions and estimates may be derived from, among others, scientific literature, third-party analyses and market research that may prove to be incorrect or inapplicable to the indications our products and product candidates target.

For example, there are no approved competitors for our products and certain of our product candidates, making it particularly difficult to estimate the market potential for our products and product candidates and how physicians, patients, caregivers, long-term care facilities and payors will respond to the price of our products or changes to the price of our products.

Further, we have developed internal assumptions regarding, for example, the prevalence of PDP and Rett syndrome, the rate of diagnosis of PDP and Rett syndrome, the prevalence and rate of hallucinations and delusions in patients diagnosed with PDP with respect to NUPLAZID, the rate of physician adoption, the potential impact of payor restrictions, and patient adherence and compliance rates, and have and will develop similar assumptions for our product candidates, some or all of which may prove to be inaccurate.

As a result, one or more of our products or product candidates may fail to meet our or the market’s expectations, including our estimates of peak sales, prevalence and incidence, which could adversely affect our business, results of operations, financial condition and prospects.

Estimating the market opportunity of our current products faces unique challenges.

For example, with respect to NUPLAZID, certain research suggests that patients with Parkinson’s disease may be hesitant to report symptoms of PDP to their treating physicians for a variety of reasons, including apprehension about societal stigmas relating to mental illness.

4 unchanged sentences

Even if NUPLAZID is prescribed for the treatment of hallucinations and delusions associated with PDP, patients may stop taking NUPLAZID because they may not see results in the timeframe they desire or expect.

Similarly, even if DAYBUE is prescribed for the treatment of Rett syndrome, issues may arise with respect to patient acceptance, adherence, persistence and compliance rates for a variety of reasons, including due to the expected clinical benefits or expected and actual side effects a patient might incur.

If patients do not adhere to the recommended dosing of DAYBUE, or do not maintain the recommended dosing of DAYBUE for sufficient periods of time, patients and physicians may believe that DAYBUE is less effective, and as a result they may discontinue taking it and prescribing it.

Additionally, if physicians or patients titrate DAYBUE below the recommended doses, patients may not experience the desired outcomes, and physicians or patients may develop negative beliefs about the effectiveness of DAYBUE and/or discontinue its use.

Similarly, even if DAYBUE products are prescribed for the treatment of Rett syndrome, issues may arise with respect to patient acceptance, adherence, persistence and compliance rates for a variety of reasons, including due to the expected clinical benefits or expected and actual side effects a patient might incur.

If patients do not adhere to the recommended dosing of DAYBUE products, or do not maintain the recommended dosing of DAYBUE for sufficient periods of time, patients and physicians may believe that DAYBUE products are less effective, and as a result they may discontinue taking it and prescribing it.

The label for NUPLAZID also contains a “boxed” warning related to particularly important prescribing information, and the FDA reminded healthcare providers to be aware of the risks described in the NUPLAZID prescribing information following its observation of potentially concerning prescribing patterns.

1 unchanged sentence

Perceptions that NUPLAZID is unsafe, even if unfounded, may discourage physicians from prescribing or patients from taking NUPLAZID.

The commercial success of our products depends on acceptance by patients, caregivers and physicians, and there are a number of factors that could skew our or others’ estimates about prescribing behaviors and market adoption.

The commercial success of our products and product candidates, if approved, depends on acceptance by patients, caregivers and physicians, and there are a number of factors that could skew our or others’ estimates about prescribing behaviors and market adoption.

If we fail to gain the acceptance of patients, caregivers and physicians, or if our estimates are inaccurate, these events could negatively impact our business, results of operations, financial condition and prospects.

Our ability to generate product revenues will be diminished if coverage for our products from commercial or government payors is not provided, is decreased or if patients have unacceptably high out-of-pocket requirements.*

Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors, including governmental healthcare programs, such as Medicare and Medicaid, managed care organizations and commercial payors, among others, to reimburse all or part of the costs associated with their prescription drugs.

Patients who are prescribed medicine for the treatment of their conditions generally rely on third-party payors, including U.S.

and foreign governmental healthcare programs, such as Medicare, Medicaid and EU member states, managed care organizations and commercial payors, among others, to reimburse all or part of the costs associated with their prescription drugs.

Coverage and adequate reimbursement from third-party payors are critical to product acceptance.

75 unchanged sentences

Our strategy includes distributing NUPLAZID in the U.S.

and DAYBUE or trofinetide, as applicable, in the U.S.

and DAYBUE products or trofinetide, as applicable, in the U.S.

and other jurisdictions in which marketing is approved solely through a limited network of third-party specialty distributors, specialty pharmacies or other third-party partners.

While we have entered into agreements with each of these distributors and pharmacies to distribute NUPLAZID in the U.S.

and DAYBUE in the U.S.

and DAYBUE products in the U.S.

and other jurisdictions in which marketing is approved, we will need to enter into similar agreements in any jurisdictions in which trofinetide is approved, and such distributors and pharmacies may not perform as agreed or they may terminate their agreements with us.

24 unchanged sentences

Also, although we have submitted a marketing application for the approval of trofinetide in the EU, there is no guarantee we will receive regulatory approval.

We are currently conducting studies with our product candidates.

We are currently conducting studies with our product candidates, including remlifanserin.

Even if we complete all planned clinical trials for our product candidates on schedule, such completion does not guarantee that we will obtain regulatory approval from the regulatory authorities.

1 unchanged sentence

In addition, completion of clinical trials does not ensure that regulatory authorities will view the results as sufficient to demonstrate safety, efficacy, or clinical benefit.

population is sufficiently representative of the desired indication in their geography or at all, the nature or existence of comparative data, size and duration of safety database, and our interpretation of meaningfulness and/or generalizability of findings.

For example, regulators may disagree with the design or implementation of our clinical trials, the appropriateness or relevance of endpoints of our clinical trials, duration of our clinical trials, whether the patient population is sufficiently representative of the desired indication in their geography or at all, the nature or existence of comparative data, size and duration of safety database, and our interpretation of meaningfulness and/or generalizability of findings.

Consequently, the successful completion of clinical trials may not be predictive of a positive outcome with any or all regulatory authorities.

10 unchanged sentences

Even if we believe the non-clinical or clinical data for trofinetide are promising, such data may not be sufficient to support approval by the European Commission or comparable foreign regulatory authorities.

For example, in January 2025, we submitted a marketing authorization application (MAA) for the approval of trofinetide for the treatment of Rett syndrome in the EU, and in January 2026 we were informed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) of a negative trend vote on our MAA for trofinetide for the treatment of Rett syndrome, following a CHMP oral explanation which led to a negative CHMP opinion in February 2026.

We requested a re-examination of the CHMP’s opinion, however, the results of the re-examination may not be favorable to us and our ability to ultimately obtain approval for trofinetide for the treatment of Rett syndrome may be negatively impacted.

The EMA or comparable foreign regulatory authorities may also require us to conduct additional preclinical studies or clinical trials for trofinetide either prior to or post-approval or may object to elements of our clinical development program.

We requested a re-examination of the CHMP’s March 2026 negative opinion, and, in June 2026, we were informed that the CHMP adopted a positive opinion following the re-examination procedure recommending the European Commission approve DAYBU (trofinetide).

However, this positive opinion may still not result in our receipt of a marketing authorization by the European Commission for DAYBU in the EU.

The EMA or comparable foreign regulatory authorities may also require us to conduct additional preclinical studies or clinical trials for DAYBU (trofinetide) either prior to or post-approval or may object to elements of our clinical development program.

If we were required to conduct such additional preclinical studies or clinical trials, the EMA or comparable foreign regulatory authorities may not agree with our interpretation of the results and we may not receive approval for trofinetide for the desired indication, or marketing of trofinetide, if approved, may be subject to additional requirements.

Trofinetide could fail to receive regulatory approval for many reasons, including the following:

DAYBU could fail to receive regulatory approval for many reasons, including the following:

• the EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials, the appropriateness or relevance of endpoints of our clinical trials, duration of our clinical trials, whether the patient population is sufficiently representative of the desired indication, the nature or existence of comparative data, size and duration of safety database, and our interpretation of meaningfulness and/or generalizability of findings;

12 unchanged sentences

Further, if we do not receive marketing approval for trofinetide in the EU or other jurisdictions outside of North America, including Japan, we will not be able to commercialize trofinetide in such jurisdictions at all.

If the results or timing of regulatory filings, the regulatory process, regulatory developments, clinical trials or preclinical studies, or other activities, actions or decisions related to DAYBUE or trofinetide do not meet our or others’ expectations, the market price of our common stock could decline significantly and the long-term success of the product and our company could be harmed.

If the results or timing of regulatory filings, the regulatory process, regulatory developments, clinical trials or preclinical studies, or other activities, actions or decisions related to DAYBUE products or trofinetide do not meet our or others’ expectations, the market price of our common stock could decline significantly and the long-term success of the product and our company could be harmed.

Expanded access or compassionate use programs could subject us to additional risks.

We currently provide and may provide in the future access to unapproved products or product candidates outside of clinical trials through expanded access or compassionate use programs (sometimes referred to as named patient or right to try programs).

These patients generally have life-threatening or severe illnesses for which there are no alternative therapies or they have exhausted all other available therapies, and unapproved products or product candidates may be provided to eligible patients based upon the request of healthcare professionals as allowed by country specific laws and regulations.

20 unchanged sentences

• difficulty monitoring multiple study sites;

• patient enrollment, which is a function of many factors, most of which is outside our control, including the size of the patient population, the nature of the protocol (including limitations in the protocol that further limit the size of the potential trial population such as, for example, our Phase 2 RADIANT study, which is subject to certain defined enrollment criteria that has caused enrollment to take longer than expected), the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial;

• patient enrollment, which is a function of many factors, most of which is outside our control, including the size of the patient population, the nature of the protocol (including limitations in the protocol that further limit the size of the potential trial population such as, for example, our Phase 2 RADIANT study, which is subject to certain defined enrollment criteria that caused enrollment to take longer than expected), the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial;

• lower than anticipated screening or retention rates of patients in clinical trials;

14 unchanged sentences

They also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may

be more appealing to high quality candidates than that which we have to offer.

Some of these characteristics may be more appealing to high quality candidates than that which we have to offer.

If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can develop and commercialize products and product candidates, if approved, will be limited.

32 unchanged sentences

product sales from our products;

• the costs of preparing applications for regulatory approvals for DAYBUE in jurisdictions other than the U.S.

• the costs of preparing applications for regulatory approvals for DAYBUE products in jurisdictions other than the U.S.

and for other product candidates, as well as the costs required to support review of such applications;

145 unchanged sentences

We depend on collaborations with third parties to develop certain of our product candidates and may need to enter into future collaborations to develop and commercialize certain of our product candidates.

In addition, we may choose to rely on collaborations in the future for our products or other product candidates, including for the commercialization of DAYBUE in selected markets outside of the U.S.

In addition, we may choose to rely on collaborations in the future for our products or other product candidates, including for the commercialization of DAYBUE products in selected markets outside of the U.S.

Our collaborators may fail to develop or effectively commercialize products using our product candidates, if approved, or technologies because they:

52 unchanged sentences

We may face delays or increased costs in our supply chain that could jeopardize the commercialization of our products.

While we currently have sufficient API for both NUPLAZID and DAYBUE and NUPLAZID and DAYBUE finished products on hand to continue our commercial and clinical operations as planned, depending on the effects of geopolitical and macroeconomic developments and whether such developments cause disruptions, we may face such delays or costs in future years.

While we currently have sufficient API for both NUPLAZID and DAYBUE products and NUPLAZID and DAYBUE finished products on hand to continue our commercial and clinical operations as planned, depending on the effects of geopolitical and macroeconomic developments and whether such developments cause disruptions, we may face such delays or costs in future years.

If any third party in our supply or distribution chain for materials or finished product is adversely impacted by geopolitical and macroeconomic developments, including rapid changes in U.S.

trade policy, such as the imposition of tariffs and trade barriers as well as potential retaliatory measures taken by other governments, our supply chain may be disrupted, limiting our ability to manufacture, test and distribute our products for commercial sales and our product candidates for our clinical trials and research and development operations.

For example, it takes approximately two years for our third-party manufacturers to produce DAYBUE API, and a supply chain disruption in DAYBUE API would cause delays or increased costs to us that could jeopardize the commercialization of DAYBUE.

Even though we have agreements with third parties for the manufacture of our products, the FDA or comparable foreign regulatory authorities may not approve the facilities of such manufacturers, the manufacturers may not perform as agreed, or the manufacturers may terminate their agreements with us.

2 unchanged sentences

We cannot estimate these delays or costs with certainty but, if they were to occur, they could cause a delay in our development and commercialization efforts, which would have a negative effect on our business, results of operations, financial condition and prospects.

The manufacturers of our products and product candidates, including Patheon, Calatent, Bend, Halo, Siegfried, Corden, FIS and Flamma, are obliged to operate in accordance with FDA-mandated and comparable foreign regulatory authorities’ cGMPs, and we have limited control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel to ensure compliance with cGMPs.

The manufacturers of our products and product candidates, including Patheon, Catalent, Bend, Halo, Siegfried, Corden, FIS and Flamma, are obliged to operate in accordance with FDA-mandated and comparable foreign regulatory authorities’ cGMPs, and we have limited control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel to ensure compliance with cGMPs.

In addition, the facilities used by our third-party manufacturers to manufacture our products and product candidates must be approved by the FDA pursuant to inspections that will be conducted prior to any grant of regulatory approval by the FDA.

32 unchanged sentences

In addition, potential competitors have in the past and may in the future file an Abbreviated New Drug Application (ANDA) with the FDA for generic versions of NUPLAZID, seeking approval prior to the expiration of our patents.

In response, we have filed complaints against these companies alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID and DAYBUE.

In response, we have filed complaints against these companies alleging infringement of certain of our Orange Book-listed patents covering NUPLAZID and DAYBUE products.

For a more detailed description of these matters, see the section captioned “Legal Proceedings” elsewhere in this report.

130 unchanged sentences

Risks Related to Government Regulation and Our Industry

Healthcare reform measures may negatively impact our ability to sell NUPLAZID, DAYBUE or our product candidates, if approved, profitably.*

Healthcare reform measures may negatively impact our ability to sell NUPLAZID, DAYBUE products or our product candidates, if approved, profitably.*

In both the U.S.

33 unchanged sentences

have also increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program proposal to import certain drugs from Canada for specific state healthcare programs.

It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada.

Any such approved importation plans, if implemented, may result in lower drug prices for products covered by those programs.

3 unchanged sentences

EU Member States, however, remain responsible for assessing non‑clinical aspects, such as economic, ethical, and social considerations, and for making pricing and reimbursement decisions at the national level.

As implementation of the HTA Regulation is phased in and key methodological and procedural guidance continues to evolve, there remains uncertainty regarding the evidence requirements, timing, and impact of joint clinical assessments on national reimbursement processes.

As implementation of the HTA Regulation is phased in and key methodological and procedural guidance continues to evolve, there remains uncertainty regarding the

evidence requirements, timing, and impact of joint clinical assessments on national reimbursement processes.

The new framework may result in additional or differently structured evidentiary expectations, misalignment between assessment and regulatory timelines, or delays in national decisions.

Any adverse or delayed HTA outcomes, or divergent national reimbursement decisions, could

negatively affect our ability to obtain or maintain favorable pricing and reimbursement status for any product candidates, if approved.

Any adverse or delayed HTA outcomes, or divergent national reimbursement decisions, could negatively affect our ability to obtain or maintain favorable pricing and reimbursement status for any product candidates, if approved.

If we are unable to maintain favorable pricing and reimbursement status in EU Member States for product candidates that we may successfully develop and for which we may obtain regulatory approval, any anticipated revenue from and growth prospects for those products in the EU could be negatively affected.

79 unchanged sentences

If there is no lawful manner for us to transfer personal data from the EEA, the UK, or other jurisdictions to the United States, or if the requirements for a legally-compliant transfer are too onerous, we could face significant adverse consequences, including by limiting our ability to conduct clinical trial activities in Europe and elsewhere, the interruption or degradation of our operations, the need to relocate part of or all of our business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against our processing or transferring of personal data necessary to operate our business.

Some European regulators have ordered certain companies to suspend or permanently cease certain transfers of personal data to recipients outside Europe for allegedly violating the GDPR’s cross-border data transfer limitations.

Additionally, companies that transfer personal data to recipients outside of the EEA and/or UK to other jurisdictions, particularly to the United States, are subject to increased scrutiny from regulators individual litigants and activist groups.

Our employees and personnel use generative artificial intelligence (AI) technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations.

Our employees and personnel use artificial intelligence (AI) technologies to perform their work.

We continue to increase our use of AI technologies across business functions and have enhanced governance frameworks, policies, and review processes intended to manage associated risks.

Despite these efforts, AI technologies may generate inaccurate, biased, incomplete, misleading, or unauthorized outputs, create intellectual property, privacy, security, operational, or regulatory risks, or otherwise adversely affect our business.

To the extent our personnel rely upon such outputs in connection with business, operational, scientific, clinical, regulatory, legal, financial, or other decisions, such reliance could result in errors, compliance risks, reputational harm, or other adverse consequences.

AI technologies, and the disclosure and use of personal data in their use, are subject to various privacy laws and other privacy obligations.

Governments have passed and are likely to pass additional laws and regulations regulating generative AI.

10 unchanged sentences

Obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty.

Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.

Additionally, emerging AI-specific regulatory regimes, including those in the European Union and other jurisdictions, may impose additional compliance obligations, governance requirements, documentation obligations, restrictions on AI use cases, or penalties for non-compliance.

These obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.

Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.

101 unchanged sentences

For example, the use of NUPLAZID for the treatment of PDP competes with off-label use of various antipsychotic drugs, including the generic drugs quetiapine, clozapine, risperidone, aripiprazole, and olanzapine.

In addition, DAYBUE competes indirectly with off-label usage of branded and generic prescription medications targeted at individual symptoms of Rett syndrome, including antiepileptics, antipsychotics, antidepressants and benzodiazepines.

In addition, DAYBUE products competes indirectly with off-label usage of branded and generic prescription medications targeted at individual symptoms of Rett syndrome, including antiepileptics, antipsychotics, antidepressants and benzodiazepines.

Further, there are several currently disclosed programs in development for Rett syndrome.

48 unchanged sentences

In the ordinary course of our business, we, or the third parties with whom we work, process proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets.

In addition, we rely, and may increasingly rely, on third-party providers of AI technologies and related infrastructure.

Changes in the availability, performance, terms of use, pricing, security posture, or legal permissibility of such technologies could adversely affect our operations, increase costs, or limit our ability to realize anticipated benefits from AI initiatives.

Cyberattacks, malicious internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity, and availability of our sensitive data and information technology systems, and those of the third parties with whom we work.

12 unchanged sentences

In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.

For example, we were made aware of a cyberattack against one of the largest prescription processors in the country in February 2024 that impacted the ability for our specialty pharmacy partners to have payors provide authorizations for patient refills and new patient starts for certain of our products.

provide authorizations for patient refills and new patient starts for certain of our products.

In April 2024, we were notified by a third-party patient support service provider of a data security incident that involved personal data of NUPLAZID patients.

4 unchanged sentences

For example, threat actors may use an initial compromise of one part of our environment to gain access to other parts of our environment, or leverage a compromise of our networks or systems to gain access to the networks or systems of third parties with whom we work, such as through phishing or supply chain attacks.

Threat actors increasingly utilize AI technologies to enhance cyberattacks, including phishing, business email compromise, impersonation, deepfake-enabled social engineering, automated reconnaissance, credential theft, and other malicious activities.

These capabilities may increase the scale, speed, sophistication, and effectiveness of attacks directed at us and the third parties with whom we work.

While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.

34 unchanged sentences

The market prices for securities of biotechnology companies in general, and drug discovery and development companies in particular, have been highly volatile and may continue to be highly volatile in the future.

From the period between January 2, 2026 to April 29, 2026, the closing price of our common stock has ranged from a low of $20.32 per share to a high of $27.51 per share.

From the period between January 2, 2026 to July 28, 2026, the closing price of our common stock has ranged from a low of $20.32 per share to a high of $27.51 per share.

Furthermore, especially as we and our market capitalization have grown, the price of our common stock has been increasingly affected by quarterly and annual comparisons with the valuations and recommendations of the analysts who cover our business.

70 unchanged sentences

OTHER INFORMATION

During the Company’s last fiscal quarter, none of our directors or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated any “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item 408 of Regulation S-K.

During the Company’s last fiscal quarter, the following officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended (the Exchange Act)) adopted or terminated a “Rule 10b5-1 trading arrangement” as defined in Item 408 of Regulation S-K, as follows:

• On May 28, 2026 , Mark C.

Schneyer , Executive Vice President and Chief Financial Officer , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 105,328 shares of our common stock.

The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c).

The duration of the trading arrangement is from November 6, 2026 until July 31, 2027 , or earlier if and when all transactions under the trading arrangement are completed.

• On June 1, 2026 , Thomas Garner , Executive Vice President and Chief Commercial Officer , adopted a Rule 10b5-1 trading arrangement providing for the sale of up to 88,771 shares of our common stock.

The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c).

The duration of the trading arrangement is from November 6, 2026 until April 1, 2027 .

Amended and Restated Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q, filed August 6, 2015).

3 unchanged sentences

Form of Amended and Restated Warrant to Purchase Common Stock issued to purchasers in a private placement on December 17, 2012 (incorporated by reference to Exhibit 4.2 to the Registrant’s Annual Report on Form 10-K, filed on February 27, 2019).

Non-Employee Director Compensation Policy, effective March 3, 2026.

Registration Rights Agreement, dated February 24, 2026, among the Registrant and the investors listed on Schedule A thereto (incorporated by reference to Exhibit 10.25 to the Registrant’s Annual Report on Form 10-K, filed February 26, 2026).

Acadia Pharmaceuticals Inc.

2024 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed May 29, 2026).

Certification of Catherine Owen Adams, Chief Executive Officer, pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

6 unchanged sentences

Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

The following financial statements from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed on May 6, 2026, formatted in iXBRL (Inline Extensible Business Reporting Language), are filed herewith:

The following financial statements from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed on August 4, 2026, formatted in iXBRL (Inline Extensible Business Reporting Language), are filed herewith:

(i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Comprehensive Income, (iv) Condensed Consolidated Statements of Cash Flows, (v) Condensed Consolidated Statements of Stockholders’ Equity and (vi) Notes to Condensed Consolidated Financial Statements.

4 unchanged sentences

Acadia Pharmaceuticals Inc.

August 4, 2026

Executive Vice President and Chief Financial Officer

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings