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Details:
The net proceeds will be used for launching Olpruva, a new formulation of sodium phenylbutyrate approved as an oral suspension by the FDA, to treat patients with urea cycle disorders.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Perceptive Advisors
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing April 10, 2024
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:
Through the acquisition, Zevra will expand its rare disease portfolio and adding commercial product including the recent U.S. commercial approval Olpruva (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zevra Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition November 20, 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:
Through the acquisition, Zevra will expand its rare disease portfolio and adding commercial product including the recent U.S. commercial approval Olpruva (sodium phenylbutyrate) for the treatment of UCDs.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zevra Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 31, 2023
Details:
Under the terms of the new agreement, Acer will reacquire worldwide development, commercialization and economic rights to OLPRUVA™ (sodium phenylbutyrate) from Relief Therapeutics, excluding the European Union. OLPRUVA™ is approved in the U.S. for treatment of UCDs.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acer Therapeutics
Deal Size: $56.5 million Upfront Cash: $11.5 million
Deal Type: Licensing Agreement August 30, 2023
Details:
Pheburane (sodium phenylbutyrate) is a taste-masked oral formulation, which is used for the treatment of as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Pheburane
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Details:
The financing will be used for the launch of company's Olpruva (sodium phenylbutyrate), an oral suspension, for the treatment of various disorders, including Maple Syrup Urine Disease (MSUD).
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Christopher Schelling
Deal Size: $1.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 26, 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:
Olpruva (sodium phenylbutyrate) active metabolite is phenylacetate which conjugates with glutamine to form phenylacetylglutamine. Phenylacetylglutamine is excreted by the kidneys, hence providing an alternate vehicle for waste nitrogen excretion.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 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:
Olpruva (sodium phenylbutyrate)active metabolite is phenylacetate which conjugates with glutamine to form phenylacetylglutamine. Phenylacetylglutamine is excreted by the kidneys, hence providing an alternate vehicle for waste nitrogen excretion.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 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:
OLPRUVA™ (sodium phenylbutyrate), is an oral suspension prescription medicine used for the treatment of rare, genetic disorders like Urea cycle disorders (UCDs) .
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Olpruva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 27, 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
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:
ACER-001 (sodium phenylbutyrate) is an immediate-release, polymer coated, multi-particulate formulation of sodium phenylbutyrate for oral administration via suspension, that is designed to improve palatability.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Rare Diseases and Disorders Product Name: ACER-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acer Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 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:
ACER-001 (sodium phenylbutyrate) is an immediate-release, polymer coated, multi-particulate formulation of sodium phenylbutyrate for oral administration via suspension, that is designed to improve palatability.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Rare Diseases and Disorders Product Name: ACER-001
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
PHEBURANE® (sodium phenylbutyrate) is indicated adjunctive therapy to standard of care, which includes dietary management, for chronic management of adult and pediatric patients with UCDs.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: Pheburane
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 19, 2022
Details:
ACER-001 (sodium phenylbutyrate) is nitrogen-binding agent in development for use as adjunctive therapy in chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase, or argininosuccinic acid synthetase.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: ACER-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 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:
The data presented concluded that taste-masked sodium phenylbutyrate (ACER-001) was bioequivalent to sodium phenylbutyrate (BUPHENYL) powder under both fed and fasting conditions.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: ACER-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Relief Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 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:
Proceeds from the foregoing two facilities would currently be expected to finance and additional investments in ACER-001 pre-commercial activities as well as activities relating to a planned ACER-801 (osanetant) Phase 2a proof of concept trial in postmenopausal women.
Lead Product(s): Sodium Phenylbutyrate
Therapeutic Area: Genetic Disease Product Name: ACER-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Marathon Asset Management
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 07, 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
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