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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
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
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
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
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
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
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
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
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
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
Details:
Albrioza (sodium phenylbutyrate and taurursodiol) function in ALS is hypothesized as the drug mitigate endoplasmic reticulum (ER) stress and mitochondrial dysfunction.
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 February 02, 2023
Details:
Amylyx Pharmaceuticals expects to use the net proceeds from the offering, for general corporate purposes and working capital, including the development of its drug product candidates including AMX0035 (sodium phenylbutyrate).
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs
Deal Size: $246.3 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 11, 2022
Details:
Amylyx Pharmaceuticals expects to use the net proceeds from the offering, for general corporate purposes and working capital, including the development of its drug product candidates including AMX0035 (sodium phenylbutyrate).
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co.
Deal Size: $214.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 06, 2022
Details:
RELYVRIO™ (sodium phenylbutyrate and taurursodiol) is an oral, fixed-dose medication approved to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada.
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 September 29, 2022
Details:
AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in United States and European Union.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 September 14, 2022
Details:
Data analyses from twelve primary fibroblast lines from healthy donors and twelve lines derived from people with ALS demonstrated that treatment with AMX0035 (sodium phenylbutyrate) changed more genes and metabolites than treatment with either PB or TURSO individually.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 September 12, 2022
Details:
AMX0035 (sodium phenylbutyrate) will be first treatment in ALS that has demonstrated significant slowing of disease progression and functional decline, as well as extended survival, in clinical trial, standalone therapy or when added to existing approved treatments.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 September 07, 2022
Details:
AMX0035 will be first treatment in ALS that has demonstrated significant slowing of disease progression and functional decline, as well as extended survival, in placebo-controlled clinical trial, as a standalone therapy or when added to existing approved treatments.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 September 07, 2022
Details:
AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union and approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis (ALS) in Canada.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 September 02, 2022
Details:
AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union, and approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis (ALS) in Canada.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 August 03, 2022
Details:
ALBRIOZA (also known as AMX0035/sodium phenylbutyrate) is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments.
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 July 29, 2022
Details:
AMX0035 (sodium phenylbutyrate) and taurursodiol (TURSO; also known as ursodoxicoltaurine) is an oral fixed-dose medication approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 July 06, 2022
Details:
AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union, and approved with conditions as ALBRIOZA™ to treat amyotrophic lateral sclerosis.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 July 05, 2022
Details:
Clinical data demonstrated statistically significant in functional outcomes for people with ALS taking ALBRIOZA (AMX0035/Sodium Phenylbutyrate) compared to people taking placebo, either as a stand-alone therapy or when added to existing treatments for ALS.
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 13, 2022
Details:
AMX0035 is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 June 03, 2022
Details:
AMX0035 is proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce UPR, preventing cell death resulting from UPR, and taurursodiol.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 May 26, 2022
Details:
Randomization to AMX0035 (sodium phenylbutyrate) resulted in a lower occurrence of death or tracheostomy/permanent assisted ventilation by 49% and first hospitalization by 44% over the Phase 2 trial and duration of follow-up.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 May 16, 2022
Details:
Participants randomized to receive AMX0035 (sodium phenylbutyrate) and who continued into the open-label extension phase showed an 18.8-month longer median survival duration than participants who never received AMX0035 in a subgroup analysis.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 May 05, 2022
Details:
Summary of data from CENTAUR and PEGASUS showed AMX0035, a proprietary oral fixed-dose combination was safe and well tolerated in clinical trials in amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD).
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 April 02, 2022
Details:
AMX0035 is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 March 28, 2022
Details:
AMX0035 is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 March 25, 2022
Details:
AMX0035, a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate, a small molecular chaperone designed to reduce the unfolded protein response, and taurursodiol, a Bax inhibitor designed to reduce cell death through apoptosis.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 March 18, 2022
Details:
Overall, reported rates of adverse events and discontinuations were similar between AMX0035 and placebo groups during the 24-week randomized phase; however, gastrointestinal events occurred with greater frequency (≥2%) in the AMX0035 group.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
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 February 25, 2022
Details:
This investment and partnership with the CNDR is an extension of long‐standing commitment to the ALS community, as company continue to uncover the full potential of AMX0035 for the benefit of people living with ALS around the world.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amylyx Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 03, 2022
Details:
Albrioza (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in the United States and European Union.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: Albrioza
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neopharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 16, 2022
Details:
Funding to support advancement of clinical development and potential launch planning of AMX0035 in ALS and further research and development in additional neurodegenerative diseases.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Viking Global Investors
Deal Size: $135.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing July 20, 2021
Details:
The study will assess the safety and efficacy of AMX0035 in an international population of people with ALS that will build upon findings from the CENTAUR trial.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2021
Details:
The analysis found that the group of participants randomized to AMX0035 at baseline had a 44% lower risk of death compared to the group who originally received placebo over the duration of follow-up.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
AMX0035 is designed to target the ER stress, and preclinical data suggest that it may be a promising approach to halt the irreversible progression of optic nerve atrophy in patients with Wolfram syndrome.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: AMX0035
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
The PEGASUS trial will provide data on the safety and tolerability profile of AMX0035 in people with Alzheimer’s disease, its biological activity on biomarkers related to disease processes and preliminary information on cognitive and functional effects of AMX0035.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
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 November 09, 2020
Details:
Data from Centaur Trial Published in Muscle & Nerve Demonstrates that administration of Amx0035 results in longer survival for people with ALS.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
Patients retained function longer on AMX0035 versus placebo; study achieved its primary outcome of a difference on the revised als functional rating scale.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Proceeds enable continued investment in lead product candidate AMX0035 in ALS and Alzheimer’s disease.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: AMX0035
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Morningside
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing July 01, 2020
Details:
Amylyx Pharmaceuticals announced it has completed enrollment in the Phase II PEGASUS trial assessing AMX0035 in individuals with Alzheimer’s disease, dosing 96 of the previously planned 100 participants.
Lead Product(s): Tauroursodeoxycholic Acid,Sodium Phenylbutyrate
Therapeutic Area: Neurology Product Name: Undisclosed
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 June 15, 2020
Details:
In late 2019, Amylyx announced that the CENTAUR clinical trial of AMX0035 in patients with ALS met its primary endpoint, demonstrating statistically significant, longer retention of function.
Lead Product(s): Sodium Phenylbutyrate,Tauroursodeoxycholic Acid
Therapeutic Area: Neurology Product Name: Undisclosed
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 29, 2020
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