Lead Product(s) : ADI-001
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Adicet Bio Announces FDA Clearance To Evaluate ADI-001 in Inflammatory Myopathy
Details : FDA has agreed to an amendment to the company’s investigational new drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome.
Brand Name : ADI-001
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
October 16, 2024
Lead Product(s) : ADI-001
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : PDA-002
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Celularity Requests U.S. FDA ODD for PDA-002 in Muscular Dystrophy Treatment
Details : PDA-002 is a placenta-derived mesenchymal-like adherent stromal cell therapy, which is being evaluated for the treatment of facioscapulohumeral muscular dystrophy.
Brand Name : PDA-002
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
March 20, 2024
Lead Product(s) : PDA-002
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : ARO-DUX4
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : ARO-DUX4 is an investigational RNAi therapeutic designed to reduce expression of the gene that encodes the human double homeobox 4 (DUX4) protein as a potential treatment for FSHD.
Brand Name : ARO-DUX4
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 17, 2023
Lead Product(s) : ARO-DUX4
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : SIS-101-ADO
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SIS-101-ADO is an siRNA that suppresses the expression of CLCN7, a mutant gene expressed by osteoclasts and other cell types responsible for causing ADO2, the RNA therapy restores bone mass and quality to nearly normal levels.
Brand Name : SIS-101-ADO
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 15, 2023
Lead Product(s) : SIS-101-ADO
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : EPI-321
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Solve FSHD
Deal Size : Undisclosed
Deal Type : Financing
Details : The investment will support development of Epic’s lead program EPI-321, a novel therapeutic that is designed to correct the epigenetic alterations in the D4Z4 region of chromosome 4.
Brand Name : EPI-321
Molecule Type : Cell and Gene therapy
Upfront Cash : Undisclosed
April 18, 2023
Lead Product(s) : EPI-321
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Solve FSHD
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : SIG002
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SIG002 consists purified secretome free of tissue fragments and cells. SIG002 has demonstrated immunoregulatory properties relevant to address the degenerative inflammatory processes involved in osteoarthritis disease etiology.
Brand Name : SIG002
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
January 31, 2023
Lead Product(s) : SIG002
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : SIS-101-ADO
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : CSSi LifeSciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SIS-101-ADO combines an siRNA that suppress expression of CLCN7, with SiSaf’s Bio-Courier® next generation silicon stabilized hybrid lipid nanoparticles technology of other RNA delivery technologies by merging LNP technology with inorganic bioabsorbab...
Brand Name : SIS-101-ADO
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 12, 2022
Lead Product(s) : SIS-101-ADO
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : CSSi LifeSciences
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : FSD201 is a proprietary formulation of ultra-micronized palmitoylethanolamide (PEA). FSD Pharma’s successfully completed Phase 1 clinical trial showed FSD201 to be safe and well tolerated.
Brand Name : FSD201
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 06, 2022
Lead Product(s) : Palmitoylethanolamide
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Diclofenac Epolamine
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Kindeva Drug Delivery
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Brand Name : Epoladerm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2022
Lead Product(s) : Diclofenac Epolamine
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Kindeva Drug Delivery
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Diclofenac Epolamine
Therapeutic Area : Musculoskeletal
Study Phase : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm
Details : Epoladerm (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.
Brand Name : Epoladerm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
Lead Product(s) : Diclofenac Epolamine
Therapeutic Area : Musculoskeletal
Highest Development Status : IND Enabling
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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