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The company intends to use the net proceeds for the clinical development of DNL310 (tividenofusp alfa), a fusion protein composed of IDS fused to Denali’s proprietary Enzyme transport vehicle. It is being evaluated in the treatment of Mucopolysaccharidosis Type II.
Lead Product(s): Tividenofusp Alfa
Therapeutic Area: Genetic Disease Product Name: DNL310
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 27, 2024
Details:
SAR443820 (DNL788) is a selective, orally bioavailable, brain penetrant RIPk1 inhibitor. It is being evaluated for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): DNL788
Therapeutic Area: Neurology Product Name: SAR443820
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2024
Details:
DNL310 is an investigational fusion protein composed of IDS fused to Denali’s proprietary ETV, which is engineered to cross the blood-brain barrier via receptor-mediated transcytosis into the brain, investigated for MPS II (Hunter Syndrome).
Lead Product(s): DNL310
Therapeutic Area: Genetic Disease Product Name: DNL310
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
Details:
DNL343 is an eIF2B agonist, being investigated for the treatment of ALS. eIF2B is an intracellular protein complex that regulates protein synthesis and is required for neuronal health and function.
Lead Product(s): DNL343
Therapeutic Area: Neurology Product Name: DNL343
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 10, 2023
Details:
DNL126 (Recombinant Iduronate 2 Sulfatase) is a recombinant SGSH enzyme engineered to cross the blood-brain barrier, replace the SGSH enzyme and treat neuropathic and systemic forms of the Sanfilippo syndrome A.
Lead Product(s): Recombinant Iduronate 2 Sulfatase
Therapeutic Area: Genetic Disease Product Name: DNL310
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
Denali and Sanofi entered partnership for the global development and commercialization of CNS-penetrant and peripherally restricted RIPK1 inhibitors. Sanofi has commenced dosing in a Phase 2 clinical trial of DNL788 (SAR443820) in individuals with multiple sclerosis.
Lead Product(s): SAR443820
Therapeutic Area: Neurology Product Name: DNL788
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $1,125.0 million Upfront Cash: $125.0 million
Deal Type: Collaboration January 25, 2023
Details:
Modulation of eIF2B activity with DNL343 is a novel and targeted investigational approach with first-in-class potential for the treatment of ALS. eIF2B is an intracellular protein complex that regulates protein synthesis and is required for neuronal health and function.
Lead Product(s): DNL343
Therapeutic Area: Neurology Product Name: DNL343
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
TAK-594/DNL593 is an investigational, intravenously administered, brain-penetrant progranulin (PGRN) replacement therapy enabled by Denali’s Protein Transport Vehicle (PTV) technology.
Lead Product(s): TAK-594
Therapeutic Area: Neurology Product Name: DNL593
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Takeda Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
Denali 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 DNL310 (recombinant iduronate 2 sulfatase).
Lead Product(s): Recombinant Iduronate 2 Sulfatase
Therapeutic Area: Genetic Disease Product Name: DNL310
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $316.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 24, 2022
Details:
Company 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 DNL310 (recombinant iduronate 2 sulfatase).
Lead Product(s): Recombinant Iduronate 2 Sulfatase
Therapeutic Area: Genetic Disease Product Name: DNL310
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co.
Deal Size: $275.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 19, 2022
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