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ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting

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SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced it will present data from its Phase 2 CLARITY study,
which evaluated the efficacy, safety, and tolerability of pimavanserin
as an adjunctive treatment for major depressive disorder (MDD) at the
2019 American Psychiatric Association Annual Meeting in San Francisco,
May 18 – 22, 2019.

Poster Presentation
Poster:
#P8-049
Date/Time: Tuesday, May 21, 2:00 p.m. – 4:00 p.m. Pacific
Time
Title: CLARITY: A Phase 2 Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in
Major Depressive Disorder

The Phase 2 CLARITY study was a 10-week, randomized, double-blind,
placebo-controlled, multi-center, two-stage sequential parallel
comparison design study that evaluated the efficacy, safety, and
tolerability of pimavanserin (34 mg once daily). Pimavanserin was
administered as an adjunctive treatment in patients with MDD who had an
inadequate response to a stable dose of standard antidepressant therapy
with either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin norepinephrine reuptake inhibitor (SNRI). The study randomized
207 patients across 27 clinical research centers in the U.S. and was
conducted in collaboration with the Massachusetts General Hospital (MGH)
Clinical Trials Network and Institute.

There is a significant need for new therapies for the majority of
patients suffering from major depressive disorder who do not respond to
initial antidepressant therapy,” said Professor Maurizio Fava, M.D.,
Executive Vice Chair, Department of Psychiatry, MGH, Director of the
Division of Clinical Research of the MGH Research Institute, and
Associate Dean for Clinical & Translational Research, Harvard Medical
School. “The results observed in the Phase 2 CLARITY study combined with
a favorable tolerability profile provides evidence that adjunctive
treatment with pimavanserin may provide meaningful benefit to those MDD
patients who have an inadequate response to either a SSRI or a SNRI
therapy.”

In the trial, pimavanserin met the overall primary endpoint of the
weighted average results of Stage 1 and Stage 2 by significantly
reducing the 17-item Hamilton Depression Rating Scale total score
compared to placebo (p=0.039). On the key secondary endpoint,
pimavanserin demonstrated statistically significant reductions compared
to placebo in the Sheehan Disability Scale score (p=0.004). Positive
results were also observed for seven other secondary endpoints,
including improvement in daytime sleepiness as measured by the
Karolinska Sleepiness Scale and improvement in sexual function as
measured by the Massachusetts General Hospital Sexual Functioning Index.

In this Phase 2 study of pimavanserin as an adjunctive treatment for
MDD, we found patients treated with pimavanserin experienced significant
reduction in their depression symptoms in addition to improvement in
daytime sleepiness and sexual function when compared to placebo,” said
Serge Stankovic, M.D., M.S.P.H., ACADIA’s President. “These results are
encouraging for patients with MDD who may experience challenges with
their current treatment options. We look forward to further evaluating
pimavanserin as an adjunctive treatment in our ongoing Phase 3 CLARITY
program.”

On April 25, ACADIA
announced
it had initiated its Phase 3 CLARITY program for
pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study
will be based in the U.S. and has already initiated enrollment and the
CLARITY-3 study will be based outside the U.S. and will initiate
enrollment in the upcoming months. Both studies are six-week,
parallel-designed, randomized, double-blind, placebo-controlled,
multi-center studies designed to evaluate the efficacy and safety of
pimavanserin as adjunctive treatment in patients with MDD who have an
inadequate response to standard antidepressant therapy with either a
SSRI or a SNRI.

About Major Depressive Disorder
According to the National
Institute of Mental Health, MDD affects approximately 16 million adults
in the U.S.1, with approximately 2.5 million adults treated
with adjunctive therapy.2,3 MDD is a condition characterized
by depressive symptoms such as a depressed mood or a loss of interest or
pleasure in daily activities for more than two weeks, as well as
impaired social, occupational, or other important functioning. The
majority of people who suffer from MDD do not respond adequately to
initial antidepressant therapy.4

About Pimavanserin
Pimavanserin is a selective serotonin
inverse agonist and antagonist preferentially targeting 5-HT2A
receptors. These receptors are thought to play an important role in
depression, psychosis, and other neuropsychiatric disorders. ACADIA is
evaluating pimavanserin in an extensive clinical development program
across multiple indications with significant unmet need including
dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, and MDD. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug Administration
in April 2016 under the trade name NUPLAZID®. NUPLAZID is not
approved for the adjunctive treatment of patients with MDD.

About ACADIA Pharmaceuticals
ACADIA is a
biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has developed and
commercialized the first and only medicine approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis. ACADIA also has ongoing clinical development efforts in
additional areas with significant unmet need, including dementia-related
psychosis, schizophrenia inadequate response, schizophrenia-negative
symptoms, major depressive disorder, and Rett syndrome. This press
release and further information about ACADIA can be found at: www.acadia-pharm.com.

Forward-Looking Statements
Statements in this press release
that are not strictly historical in nature are forward-looking
statements. These statements include, but are not limited to, statements
related to: the potential benefits of pimavanserin as adjunctive
treatment for MDD or other central nervous system disorders as well as
the potential results of clinical trials of pimavanserin in other
indications. These statements are only predictions based on current
information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from those
projected in any of such statements due to various factors, including
the risks and uncertainties inherent in drug development, approval and
commercialization, and the fact that past results of clinical trials may
not be indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K for
the year ended December 31, 2018 as well as ACADIA’s subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.

Important Safety Information and Indication for
NUPLAZID (pimavanserin)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS

  • Elderly patients with dementia-related psychosis treated with
    antipsychotic drugs are at an increased risk of death.
  • NUPLAZID is not approved for the treatment of patients with
    dementia-related psychosis unrelated to the hallucinations and
    delusions associated with Parkinson’s disease psychosis.
  • Contraindication: NUPLAZID is contraindicated in patients with
    a history of a hypersensitivity reaction to pimavanserin or any of its
    components. Rash, urticaria, and reactions consistent with angioedema
    (e.g., tongue swelling, circumoral edema, throat tightness, and
    dyspnea) have been reported.
  • QT Interval Prolongation: NUPLAZID prolongs the QT interval.

    • The use of NUPLAZID should be avoided in patients with known QT
      prolongation or in combination with other drugs known to prolong
      QT interval including Class 1A antiarrhythmics or Class 3
      antiarrhythmics, certain antipsychotic medications, and certain
      antibiotics.
    • NUPLAZID should also be avoided in patients with a history of
      cardiac arrhythmias, as well as other circumstances that may
      increase the risk of the occurrence of torsade de pointes and/or
      sudden death, including symptomatic bradycardia, hypokalemia or
      hypomagnesemia, and presence of congenital prolongation of the QT
      interval.
  • Adverse Reactions: The most common adverse reactions (≥2% for
    NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%),
    nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs
    3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
  • Drug Interactions:

    • Coadministration with strong CYP3A4 inhibitors (e.g.,
      ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to
      10 mg taken orally as one tablet once daily.
    • Coadministration with strong or moderate CYP3A4 inducers reduces
      NUPLAZID exposure. Avoid concomitant use of strong or moderate
      CYP3A4 inducers with NUPLAZID.

Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.

Dosage and Administration: Recommended dose: 34 mg capsule taken
orally once daily, without titration.

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please see the full Prescribing
Information
including Boxed WARNING for NUPLAZID.

References
1National Institute of Mental Health.
(2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml.

2IMS NSP, NPA, NDTI MAT-24 month data through Aug-2017.

3PLOS One, Characterization of Treatment Resistant Depression
Episodes in a Cohort of Patients from a US Commercial Claims
Database, Oct 2013, Vol 8, Issue 10.

4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp.
1905-1917 (STAR*D Study).

Contacts

Investor Contact:
ACADIA Pharmaceuticals Inc.
Mark
Johnson, CFA
(858) 261-2771
ir@acadia-pharm.com

Media Contact:
ACADIA Pharmaceuticals Inc.
Maurissa
Messier
(858) 768-6068
media@acadia-pharm.com

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Bragar Eagel & Squire, P.C. Announces That a Class Action Lawsuit Has Been Filed Against Ollie’s Bargain Outlet Holdings, Inc. (NASDAQ: OLLI) and Encourages Ollie’s Investors to Contact the Firm

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NEW YORK–(BUSINESS WIRE)–#classaction–Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all investors that purchased Ollie’s Bargain Outlet Holdings, Inc. (NASDAQ: OLLI) securities between June 6, 2019 and August 28, 2019 (“the “Class Period”). Investors have until November 18, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

On August 28, 2019, Ollie’s reported that store sales decreased 1.7% during the second quarter of 2019. Further, Ollie’s disclosed that a “bottleneck issue” had existed in its supply chain “for most all of Q2” and was not corrected until “the last week of the quarter.”

On this news, shares of Ollie’s fell $21.41 per share, or over 27%, to close at $56.36 per share on August 29, 2019.

The complaint, filed on September 17, 2019, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the company suffered a supply chain issue that impacted the initial inventory available at new stores; (2) that, as a result, the company lacked sufficient inventory to meet demand at certain store locations; (3) that, as a result, the company’s comparable store sales were likely to decrease quarter-over-quarter; and (4) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects, were materially misleading and/or lacked a reasonable basis.

If you purchased Ollie’s securities during the Class Period, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at investigations@bespc.com, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information concerning the Ollie’s lawsuit, please go to https://bespc.com/olli. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648

investigations@bespc.com
www.bespc.com

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Business Wire

Bragar Eagel & Squire, P.C. Announces That a Class Action Lawsuit Has Been Filed Against DXC Technology Company (NYSE: DXC) and Encourages DXC Investors to Contact the Firm

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NEW YORK–(BUSINESS WIRE)–#DXC–Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all investors that purchased DXC Technology Company (NYSE: DXC) securities pursuant to and/or traceable to the company’s April 2017 registration statement and prospectus. Investors have until November 15, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

In April of 2017 DXC was created when Hewlett Packard Enterprise Company’s Enterprise Services segment was spun off and merged with Computer Sciences Corporation. In conjunction with this transaction, DXC issued a registration and prospectus.

On February 6, 2019, a civil complaint was filed alleging that certain officers of the company were using cost-cutting efforts such as layoffs to inflate short-term financial metrics and that these efforts substantially decreased the company’s ability to deliver contractually obligated services to its clients.

On August 8, 2019, the company lowered its fiscal 2020 revenue guidance by $500 million compared to previously issued guidance.

On this news, the company’s share price fell $15.74, or over 30%, to close at $35.91 per share on August 9, 2019, thereby injuring investors.

The complaint, filed on September 16, 2019, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the planned “workforce optimization” plan involved implementing arbitrary quotas; (2) that the plan would cut thousands of jobs at the company; (3) that jobs that were particularly at risk of being cut were held by longer-tenured, knowledgeable, and highly compensated senior personnel; (4) that these job terminations were selectively timed to artificially inflate reported earnings and other financial metrics; (5) that, at the time of the merger, defendant Lawrie had forecasted plans for a $2.7 billion workforce reduction in the first year; (6) that, as a result of these workforce terminations, the company was unlikely to deliver on client contracts; (7) that, as a result of the foregoing, the company’s clients would be dissatisfied and the relationships would be impaired; and (8) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects, were materially misleading and/or lacked a reasonable basis.

On the date the complaint was filed, DXC stock traded as low as $32.34 per share, a 45% decline from the $59 per share price at the time of the spin-off and merger.

If you purchased DXC securities during the Class Period, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at investigations@bespc.com, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information concerning the DXC lawsuit, please go to https://bespc.com/dxc-2. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648

investigations@bespc.com
www.bespc.com

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Bragar Eagel & Squire, P.C. Announces That a Class Action Lawsuit Has Been Filed Against ProPetro Holdings Corp. (NYSE: PUMP) and Encourages ProPetro Investors to Contact the Firm

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NEW YORK–(BUSINESS WIRE)–#ProPetro–Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the United States District Court for Western District of Texas on behalf of all investors that purchased ProPetro Holdings Corp. (NYSE: PUMP) securities between March 14, 2017 and August 8, 2019 (“the “Class Period”). Investors have until November 15, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Click here to participate in the action.

In March 2017, the company completed its initial public offering (“IPO”), in which it sold 25 million shares of common stock at $14.00 per share.

On August 8, 2019, the company issued a press release delaying its second quarter earnings conference call and quarterly report, citing an ongoing review by its audit committee. In a Form 8-K filed with the SEC on the same day, the company stated that the review concerned, among other things, expense reimbursements and certain transactions involving related parties or potential conflicts of interest. The Form 8-K also stated that approximately $370,000 had been improperly reimbursed to members of senior management since the IPO.

On this news, the company’s share price fell $4.59 per share, or over 26%, to close at $12.75 per share on August 9, 2019.

By the date this class action was filed, ProPetro stock was trading as low as $11.44 per share, a nearly 18% decline from the $14 per share IPO price.

The complaint, filed on September 16, 2019, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that the company’s executive officers were improperly reimbursed for certain expenses; (2) that the company had engaged in certain undisclosed transactions with related parties; (3) that the company lacked adequate disclosure controls and procedures; (4) that the company lacked effective internal control over financial reporting; and (5) that, as a result of the foregoing, defendants’ positive statements about the company’s business, operations, and prospects, were materially misleading and/or lacked a reasonable basis.

If you purchased ProPetro securities during the Class Period, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at investigations@bespc.com, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

Bragar Eagel & Squire, P.C. is a New York-based law firm concentrating in commercial and securities litigation. For additional information concerning the ProPetro lawsuit, please go to https://bespc.com/pump. For additional information about Bragar Eagel & Squire, P.C. please go to www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648

investigations@bespc.com
www.bespc.com

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