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[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"Celavet","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celavet Inc. 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SiSaf

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SiSaf's Innovative RNA Therapeutic for Rare Genetic Skeletal Disorders Begins the U.S. Regulatory Process for Orphan Drug Designation

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 bioabsorbable silicon.

Lead Product(s): SIS-101-ADO

Therapeutic Area: Musculoskeletal Product Name: SIS-101-ADO

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: CSSi LifeSciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 12, 2022

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FSD Pharma

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FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome

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.

Lead Product(s): Palmitoylethanolamide

Therapeutic Area: Musculoskeletal Product Name: FSD201

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2022

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Virpax Pharmaceuticals

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Virpax Pharmaceuticals Selects Kindeva Drug Delivery as Development Partner for Diclofenac pMDI Commercialization

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.

Lead Product(s): Diclofenac Epolamine

Therapeutic Area: Musculoskeletal Product Name: Epoladerm

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Kindeva Drug Delivery

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2022

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Virpax Pharmaceuticals

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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.

Lead Product(s): Diclofenac Epolamine

Therapeutic Area: Musculoskeletal Product Name: Epoladerm

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 22, 2022

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MiMedx

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Two New Studies Demonstrate In Vitro Bioactivity Potential of Micronized Dehydrated Human Amnion Chorion Membrane (mdHACM) to Prevent Pathological Processes Underlying Oste...

Details:

Data show mdHACM mitigates effects of inflammatory-induced degeneration in chondrocytes, the Primary Cell Type in Cartilage. These results further support mdHACM as an investigational new drug candidate for the treatment of OA and highlight potential disease activities.

Lead Product(s): Micronized Dehydrated Human Amnion Chorion Membrane

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 01, 2021

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Virpax Pharmaceuticals

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Virpax ® Pharmaceuticals Announces Closing of a $ 40 Million Public Offering of Common Stock

Details:

Virpax intends to use the net proceeds from the offering to fund research and development of the Epoladerm, Probudur, Envelta and AnQlar indications and other development programs in clinical trial.

Lead Product(s): Diclofenac

Therapeutic Area: Musculoskeletal Product Name: Epoladerm

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $40.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 16, 2021

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Avidity Biosciences

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Avidity Biosciences Completes $100 Million Series C Financing

Details:

The funds will enable Avidity to advance Company's growing proprietary portfolio of multiple programs, including Its AOC treatment of myotonic dystrophy type I, to treat serious muscle disorder.

Lead Product(s): Antibody-Oligonucleotide Conjugates

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: RTW Investments

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing May 26, 2020

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Virpax Pharmaceuticals

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Virpax Completes Pre-IND Meeting with FDA on Epoladerm

Details:

FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm™, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug.

Lead Product(s): Diclofenac Epolamine

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2020

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Celavet

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Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA’s Center for Veterinary Medicine

Details:

Celavet is submitting the study protocol to the CVM for Investigational New Animal Drug (INAD) status.

Lead Product(s): OK100 stem cell

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2020

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Novartis Pharmaceuticals Corporation

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Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)

Details:

The Phase 2 trial is a multicenter, randomized, placebo-controlled study that will evaluate the safety and efficacy of CAD-1883. Efficacy outcome measures.

Lead Product(s): Cad-1883

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 23, 2020

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