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Find Musculoskeletal Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Tofacitinib Citrate

            Therapeutic Area: Musculoskeletal Product Name: Xeljanz

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 06, 2020

            Details:

            The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo at week 16.

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            Lead Product(s): PF-06939926

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2020

            Details:

            The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events.

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            Lead Product(s): PF-06939926

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 10, 2020

            Details:

            First ever Phase III gene therapy clinical trial for Duchenne muscular dystrophy.

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            Lead Product(s): Tolperisone

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 23, 2020

            Details:

            The published clinical data demonstrates the potential benefit of tolperisone in the treatment of acute and painful muscle spasms. The data supports and strengthens a planned Phase 3 RESUME-1 study, for which Neurana will begin enrollment imminently.

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            Lead Product(s): Pegadricase

            Therapeutic Area: Musculoskeletal Product Name: SEL-212

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 30, 2020

            Details:

            Patients with tophi showed a substantially higher overall response rate for SEL-212 versus pegloticase and a statistically significant overall reduction in mean SUA levels for SEL-212 versus pegloticase.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            Tonix is currently enrolling into a second potentially pivotal Phase 3 trial, F306 or the RALLY study, to study TNX-102 SL for the management of fibromyalgia, with topline data expected in the second half of 2021.

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            Lead Product(s): Abaloparatide

            Therapeutic Area: Musculoskeletal Product Name: BA058

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Both of the current Phase 3 trials are studying TNX-102 SL at a dose of 5.6 mg which is twice the 2.8 mg dose used in the Company’s prior Phase 2 and 3 studies in fibromyalgia.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 10, 2020

            Details:

            Tonix Pharmaceuticals has met its target enrollment of approximately 470 participants in its Phase 3 RELIEF trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, ahead of schedule.

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            Lead Product(s): Lorecivivint

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2020

            Details:

            Phase 2a data highlight the disease modifying promise of lorecivivint based on its ability to slow joint space narrowing, while durably improving pain and function over one year.

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