Extrapyramidal symptoms

Evoke Pharma to Participate in the 2022 American College of Gastroenterology Annual Scientific Meeting

Retrieved on: 
Thursday, October 20, 2022
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SOLANA BEACH, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced that the Company will participate in the 2022 American College of Gastroenterology Annual Scientific Meeting taking place from October 21 – 26, 2022 in Charlotte, North Carolina. Also, as a nominee for the Healio Industry Breakthrough Product Award, Evoke will attend the Healio Disruptive Innovators Awards Program on Sunday, October 23rd, in Charlotte during the ACG meeting.

Key Points: 
  • FollowEvoke Pharmaon Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
    FollowEvoke Pharmaon LinkedIn: https://www.linkedin.com/company/evoke-pharma/
    GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
  • Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements.
  • The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved.
  • This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

GIMOTI Receives Nomination for 2022 Healio Industry Breakthrough Award

Retrieved on: 
Wednesday, September 14, 2022
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SOLANA BEACH, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that its flagship product, GIMOTI has been nominated for Healio’s Annual Disruptive Innovators Awards under the Healio Industry Breakthrough Award category. GIMOTI was selected amongst other novel gastroenterology products from major pharmaceutical companies.

Key Points: 
  • The Disruptive Innovators Awards hosted by Healio is an annual event to celebrate the trailblazers, movers, and industry name-makers that are creating a revolution in gastroenterology.
  • "We are extremely honored to receive the nomination for GIMOTI as a Healio Disruptive Innovator.
  • We look forward to the Healio organization's unveiling of the award winners in each category and encourage all Evoke supporters to access the Healio survey and vote for GIMOTI."
  • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.

Evoke Pharma Regains Compliance with Nasdaq Listing Requirements and Provides Financial Update

Retrieved on: 
Wednesday, June 8, 2022
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As previously disclosed, in early May, the Company utilized its at-the-market program to raise proceeds of approximately $7.1 million, net of commissions and fees.

Key Points: 
  • As previously disclosed, in early May, the Company utilized its at-the-market program to raise proceeds of approximately $7.1 million, net of commissions and fees.
  • Matt DOnofrio, MBA, Chief Business Officer of Evoke Pharma commented, We are pleased to regain compliance with the Nasdaq listing standards.
  • In conjunction, we are happy to announce that weve substantially bolstered our cash reserves and extended operational runway.
  • We believe the additional capital positions us to sustain and increase GIMOTI sales and to capitalize on future market opportunities.

Evoke Pharma to Present at H.C. Wainwright Global Investment Conference

Retrieved on: 
Tuesday, May 17, 2022
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In addition, management will be available for one-on-one meetings during the conference.

Key Points: 
  • In addition, management will be available for one-on-one meetings during the conference.
  • Registered investors will be able to request a meeting with management via the conference portal.
  • Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases.
  • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.

Evoke Pharma Announces Approval of GIMOTI® to the Texas Medicaid Preferred Drug List

Retrieved on: 
Tuesday, April 19, 2022
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This decision supports reimbursement for GIMOTI on the Texas Medicaid formulary and associated programs which provides healthcare to an estimated 5 million people.

Key Points: 
  • This decision supports reimbursement for GIMOTI on the Texas Medicaid formulary and associated programs which provides healthcare to an estimated 5 million people.
  • According to Texas Health and Human Services, preferred drugs are medications recommended by the Texas Drug Utilization Review Board for their efficaciousness, clinical significance, cost effectiveness, and safety.
  • The Medicaid Formulary contains all products, including those on the preferred drug list, available to people enrolled in Medicaid.
  • GIMOTI will be available for those that fail treatment with any preferred drug class.

Evoke Pharma Announces Key Opinion Leader Fireside Chat to Discuss Gastroparesis Treatment Landscape

Retrieved on: 
Thursday, March 10, 2022
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Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases.

Key Points: 
  • Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases.
  • The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
  • The gastric delay caused by gastroparesis can compromise absorption of orally administered medications.
  • FollowEvoke Pharmaon Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
    FollowEvoke Pharmaon LinkedIn: https://www.linkedin.com/company/evoke-pharma/
    GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Evoke Pharma Reports Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Tuesday, March 8, 2022
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SOLANA BEACH, Calif., March 08, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2021, and recent corporate developments.

Key Points: 
  • Our net product sales from prescriptions increased sequentially by 46%, to $361,000 in the fourth quarter of 2021 from $247,000 in the third quarter.
  • Fourth Quarter 2021 Developments and Recent Progress:
    Conducted higher number of in-person meetings with HCPs in many areas of the U.S.
  • Research and development expenses totaled approximately $36,000 for the fourth quarter of 2021 compared with $0.1 million for the fourth quarter of 2020.
  • For the fourth quarter of 2021, selling, general and administrative expenses were approximately $1.7 million compared with $2.0 million for the fourth quarter of 2020.

Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

Retrieved on: 
Wednesday, February 9, 2022
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Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride (SEP-4199) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion) and Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) today announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride (SEP-4199) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).
  • We are encouraged by our Phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression.
  • Through our collaboration with Sunovion, we hope to advance SEP-4199, which we believe shows promise for the treatment of people with bipolar depression.
  • Non-racemic amisulpride (85:15 ratio of aramisulpride to esamisulpride; SEP-4199) is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression).

Evoke Pharma and EVERSANA Extend Commercialization Partnership to Further Support GIMOTI

Retrieved on: 
Wednesday, February 2, 2022
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According to the original agreement signed in January 2020, Evoke retains ownership of the Gimoti NDA and legal, regulatory, and manufacturing responsibilities for Gimoti.

Key Points: 
  • According to the original agreement signed in January 2020, Evoke retains ownership of the Gimoti NDA and legal, regulatory, and manufacturing responsibilities for Gimoti.
  • EVERSANA utilizes its internal sales organization and other commercial functions for market access, marketing, distribution, and other patient support services.
  • Evoke records sales for Gimoti and retains more than 80% of the net product profits once the parties costs are reimbursed.
  • This amendment increases the percentage of net product profit retained by Evoke and accelerates the reimbursement of commercialization costs to Eversana after the product breaks even on a monthly basis.

Intra-Cellular Therapies Announces Publication of Lumateperone Pivotal Phase 3 Study in Bipolar Depression in The American Journal of Psychiatry

Retrieved on: 
Monday, September 27, 2021
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NEW YORK, Sept. 27, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the publication of the results from its lumateperone monotherapy Phase 3 clinical trial (ITI-007-404). The article, "Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial,” was published online in The American Journal of Psychiatry and is available here.

Key Points: 
  • The article, "Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated with Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial, was published online in The American Journal of Psychiatry and is available here .
  • Study 404 assesed the efficacy and safety of lumateperone as monotherapy in patients with bipolar I or bipolar II disorder experiencing a major depressive episode (bipolar depression).
  • This global study randomized 381 patients with moderate to severe depression symptoms to receive placebo or lumateperone 42 mg for 6 weeks.
  • Lumateperone is being investigated for the treatment of bipolar depression, major depressive disorder, and other neuropsychiatric and neurological disorders.