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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Cassava, and Amylyx and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, February 22, 2024

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX

Fortrea Increases Patient Access Capabilities and Cold Chain Expertise with FortreaRx™ Expansion

Retrieved on: 
Tuesday, February 20, 2024

"From our expertise in broad-range disease states to our unwavering commitment to patient assistance, Fortrea excels at delivering timely and impactful solutions to our pharmaceutical sponsors that strive to reduce patient and provider challenges by streamlining enrollment processes and by offering full integration with broader patient support initiatives."

Key Points: 
  • "From our expertise in broad-range disease states to our unwavering commitment to patient assistance, Fortrea excels at delivering timely and impactful solutions to our pharmaceutical sponsors that strive to reduce patient and provider challenges by streamlining enrollment processes and by offering full integration with broader patient support initiatives."
  • FortreaRx’s call center hub of case managers seamlessly manages patient inquiries, counseling and data verification of prescriptions.
  • Fortrea’s patient access team helps patients and providers understand and navigate the complexities of coverage while removing obstacles to get medication to patients.
  • FortreaRx delivers efficient, consultative and cost-effective solutions for manufacturer prescription programs typically resulting in significant yearly savings for patients.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Amylyx Pharmaceuticals, Inc. of Class Action Lawsuit and Upcoming Deadlines – AMLX

Retrieved on: 
Tuesday, February 20, 2024

NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) (NASDAQ: AMLX) and certain officers.

Key Points: 
  • NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Amylyx Pharmaceuticals, Inc. (“Amylyx” or the “Company”) (NASDAQ: AMLX) and certain officers.
  • To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

AMYLYX PHARMACEUTICALS, INC. (NASDAQ: AMLX) DEADLINE ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against Amylyx Pharmaceuticals, Inc.

Retrieved on: 
Tuesday, February 20, 2024

If you purchased or acquired Amylyx securities, and/or would like to discuss your legal rights and options please visit Amylyx Pharmaceuticals, Inc.

Key Points: 
  • If you purchased or acquired Amylyx securities, and/or would like to discuss your legal rights and options please visit Amylyx Pharmaceuticals, Inc.
  • If you wish to serve as lead plaintiff, you must move the Court no later than April 9, 2024.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

MangoRx Launches Direct-To-Clinics Sales Division to Drive and Fuel Customer Acquisition and Revenue Growth

Retrieved on: 
Tuesday, February 20, 2024

Dallas, Texas, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products via a secure telemedicine platform, including its uniquely formulated erectile dysfunction (ED) drug (‘Mango’), its hair growth product (‘GROW’), and its FDA approved oral testosterone replacement therapy (TRT), ‘PRIME’, by MangoRx, powered by Kyzatrex®️, is excited to announce that it has officially launched its direct-to-clinics sales division offering doctors and medical practitioners the ability to prescribe MangoRx products to their patients directly from their offices, clinics and brick and mortar locations. The Company also reports that it has successfully onboarded its first medical health and wellness clinic based in Dallas, TX last week.

Key Points: 
  • The Company also reports that it has successfully onboarded its first medical health and wellness clinic based in Dallas, TX last week.
  • The Company believes that this direct-to-clinics initiative will assist in fueling a greater amount of recurring revenues while at the same time reducing customer acquisition costs (CACs) associated with traditional digital marketing strategies.
  • The Company will be activating a website where providers and clinics can visit to complete the onboarding process to qualify as a MangoRx preferred provider.
  • We are confident that this new initiative will fuel our revenue growth and have a further impact on making MangoRx a household name.”

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 20, 2024

Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.

Key Points: 
  • Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.
  • Total costs of revenue were $7.4 million and $26.1 million for the fourth quarter and full year of 2023, respectively.
  • Approximately 84,000 prescriptions were written for Auvelity in the fourth quarter of 2023, representing a 23% sequential increase versus the third quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter and full year 2023 financial results as well as to provide a corporate update.

AMLX INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that Amylyx Pharmaceuticals, Inc. Investors with Substantial Losses Have Opportunity to Lead Case

Retrieved on: 
Tuesday, February 20, 2024

), the Amylyx class action lawsuit charges Amylyx as well as certain of Amylyx’s top current and former executives with violations of the Securities Exchange Act of 1934.

Key Points: 
  • ), the Amylyx class action lawsuit charges Amylyx as well as certain of Amylyx’s top current and former executives with violations of the Securities Exchange Act of 1934.
  • A lead plaintiff acts on behalf of all other class members in directing the Amylyx class action lawsuit.
  • The lead plaintiff can select a law firm of its choice to litigate the Amylyx class action lawsuit.
  • An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Amylyx class action lawsuit.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Cassava, and Amylyx and Encourages Investors to Contact the Firm

Retrieved on: 
Sunday, February 18, 2024

Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.

Key Points: 
  • Stockholders have until the deadlines below to petition the court to serve as lead plaintiff.
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects.
  • For more information on the Amylyx class action go to: https://bespc.com/cases/AMLX

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

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      Table of contents

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      Executive summary ..................................................................................... 3

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      1.

    • Specific effects ................................................................................................. 17

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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

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      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

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      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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      quality and clinical development according to the current knowledge.

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

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      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

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      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      product specific.

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      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      7.1.

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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Lost Money in Amylyx Pharmaceuticals, Inc.? Gibbs Law Group Investigates Potential Securities Law Violations

Retrieved on: 
Friday, March 8, 2024

Gibbs Law Group reminds investors that a lawsuit has been filed against Amylyx Pharmaceuticals, Inc. (“Amylyx Pharmaceuticals”) (NASDAQ: AMLX), on behalf of investors who purchased or acquired shares between November 11, 2022, and November 8, 2023.

Key Points: 
  • Gibbs Law Group reminds investors that a lawsuit has been filed against Amylyx Pharmaceuticals, Inc. (“Amylyx Pharmaceuticals”) (NASDAQ: AMLX), on behalf of investors who purchased or acquired shares between November 11, 2022, and November 8, 2023.
  • What Should Amylyx Pharmaceuticals Investors Do?
  • Our investigation concerns whether Amylyx Pharmaceuticals has violated federal securities laws by providing false or misleading statements to investors.
  • Following this announcement, Amylyx Pharmaceuticals shares plummeted over 81% in intraday trading on March 8, 2024, causing significant harm to investors.