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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): Amniotic suspension allograft
Therapeutic Area: Musculoskeletal Product Name: ReNu
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 January 14, 2021
Details:
The Phase 3 study is a prospective, double-blind, multicenter, placebo-controlled, parallel group, randomized control trial (RCT) of ReNu in 474 subjects with moderate to severe symptomatic knee osteoarthritis.
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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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