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    Amylyx Pharmaceuticals
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    43 Thorndike St., Cambridge MA 02141
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    +1 617-682-0917
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    enquiries@pharmacompass.com
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    https://www.amylyx.com/
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    https://twitter.com/amylyxpharma

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    • Development Update
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    Amylyx Pharmaceuticals Announces Interim Data From Ongoing Phase 2 HELIOS Clinical Trial Demonstrating Improvements in Pancreatic Function and Glycemic ...

    Details:

    Relyvrio (taurursodiol and sodium phenylbutyrate) is a glutamine chelator small molecule drug candidate, available in the form of oral powder in sachet. It is currently being evaluated for the treatment of wolfram syndrome.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 10, 2024

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    Amylyx to Pull Failed ALS Drug Relyvrio From Market, cut 70% of Staffers

    Details:

    Relyvrio (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication, indicated for the treatment amyotrophic lateral sclerosis, it is currently in discussion with FDA & Health Canada for voluntarily discontinuation of its marketing authorizations.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 05, 2024

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    Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS

    Details:

    Relyvrio (sodium phenylbutyrate and taurursodiol) is a specially formulated oral fixed-dose combination, which is being evaluated for the treatment of Amyotrophic Lateral Sclerosis.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 08, 2024

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    Amylyx Pharmaceuticals Announces Completion of Enrollment in HELIOS, a Phase 2 Study of AMX0035 for the Treatment of Wolfram Syndrome

    Details:

    Relyvrio (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose combination. It is a HDAC inhibitor which is being evaluated in phase 2 clinical trials for the treatment of Wolfram syndrome.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Rare Diseases and Disorders Product Name: Relyvrio

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 08, 2024

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    Amylyx Pharmaceuticals Announces First Participant Dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP)

    Details:

    Amylyx investigational product Relyvrio (sodium phenylbutyrate) with Taurursodiol, is an oral, fixed-dose combination therapy. It is being evaluated in the Phase III clinical trial studies with patient for the treatment of Progressive Supranuclear Palsy.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: Phase IIIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 22, 2023

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    Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Un...

    Details:

    AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]), under the trade name Albrioza, received negative opinion from CHMP, for the treatment of amyotrophic lateral sclerosis (ALS).


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: AMX0035

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 13, 2023

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    Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France

    Details:

    Albrioza (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) currently being indicated for the treatment of amyotrophic lateral sclerosis.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 05, 2023

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    Amylyx Pharmaceuticals Receives CHMP Negative Opinion on Its Conditional Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the...

    Details:

    Albrioza (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) currently being investigated for the treatment of wolfram syndrome.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Albrioza

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 23, 2023

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    Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS in the European Union

    Details:

    Relyvrio (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication, indicated for the treatment amyotrophic lateral sclerosis, it is currently undergoing CHMP review for market authorisation for the same indication.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Neurology Product Name: Relyvrio

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 30, 2023

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    Amylyx Pharmaceuticals Announces First Participant Dosed in Phase 2 Study of AMX0035 for the Treatment of Wolfram Syndrome

    Details:

    Albrioza (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) currently being investigated for the treatment of wolfram syndrome.


    Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid

    Therapeutic Area: Genetic Disease Product Name: Relyvrio

    Highest Development Status: Phase IIProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 13, 2023

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