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Find Musculoskeletal Drugs in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): Losmapimod

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 01, 2020

            Details:

            Fulcrum will present four posters on its integrated approach to the evaluation of FSHD patients, highlighting the progress made in the development of imaging and molecular biomarkers in FSHD and the design of clinical trials of losmapimod in FSHD patients.

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            Lead Product(s): NYX-2925

            Therapeutic Area: Musculoskeletal Product Name: NYX-2925

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 28, 2020

            Details:

            Aptinyx has re-activated study sites and recommenced patient recruitment in a Phase 2 study of NYX-2925 in patients with fibromyalgia. Enrollment in the study had been suspended in March 2020 due to the escalation of the COVID-19 pandemic in the United States.

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            Lead Product(s): IMC-1

            Therapeutic Area: Musculoskeletal Product Name: IMC-1

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: ThinkEquity

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 25, 2020

            Details:

            The company's lead candidate, IMC-1, is a novel combination antiviral therapy designed to synergistically suppress Herpes Simplex Virus-1activation and replication, with the end goal of reducing viral mediated disease burden.

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            Lead Product(s): IMC-1

            Therapeutic Area: Musculoskeletal Product Name: IMC-1

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $35.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering August 28, 2020

            Details:

            The company's lead candidate, IMC-1, is a novel combination antiviral therapy designed to synergistically suppress Herpes Simplex Virus-1activation and replication, with the end goal of reducing viral mediated disease burden.

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            Lead Product(s): UBX0101

            Therapeutic Area: Musculoskeletal Product Name: UBX0101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 17, 2020

            Details:

            There was no statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline in WOMAC-A, an established measurement of pain in OA.

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            Lead Product(s): Losmapimod

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2020

            Details:

            Results from the interim analysis in the first 29 randomized subjects indicate that DUX4-driven gene expression did not show a separation from placebo at 16 weeks.

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            Lead Product(s): Pegadricase

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB

            Deal Size: $100.0 million Upfront Cash: $100.0 million

            Deal Type: Licensing Agreement July 28, 2020

            Details:

            The licensing agreement includes the global rights, excluding China, for the product SEL-212. SEL-212 is a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme that is designed for the treatment of chronic refractory gout.

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            Lead Product(s): Pegadricase

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement June 11, 2020

            Details:

            This strategic licensing agreement is for SEL-212, a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase) for the treatment of chronic refractory gout.

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            Lead Product(s): Tolperisone

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

            Details:

            The study is a randomized, 4-period, crossover study designed to investigate the effects of tolperisone on measures of drowsiness and cognitive function compared to cyclobenzaprine and placebo.

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            Lead Product(s): Longeveron Mesenchymal Stem Cells

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            The Phase 2 study will assess the safety and efficacy of Longeveron's stem cell treatment under Japan's accelerated regulatory pathway for regenerative medicine.

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