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Details:
The net proceeds will be used to fund the clinical development of the company's lead product Tonmya (cyclobenzaprine HCl). Currently, it is being evaluated for treating patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dawson James Securities
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 27, 2024
Details:
Tonmya (cyclobenzaprine HCl) is a sublingual product candidate & a 5-HT2 receptor inhibitor. It is being evaluated for the treatment of patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2024
Details:
The net proceeds will be used to fund the clinical development of the company's lead product Tonmya (cyclobenzaprine HCl). Currently, it is being evaluated for treating patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dawson James Securities
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 13, 2024
Details:
The net proceeds will be used to fund the clinical development of the company's lead product Tonmya (cyclobenzaprine HCl). Currently, it is being evaluated for treating patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dawson James Securities, Inc
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 12, 2024
Details:
The net proceeds will be used to fund the clinical development of the company's lead product Tonmya (cyclobenzaprine HCl). Currently, it is being evaluated for treating patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dawson James Securities
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering June 11, 2024
Details:
The agreement aims for the potential launch and commercialization of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a centrally acting, non-opioid medication, in the US.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 20, 2024
Details:
Tonmya (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated for the treatment of fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2024
Details:
Tonmya (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated for the treatment of fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2024
Details:
The collaboration aims to support Tonix to focus on the Tonmya (cyclobenzaprine HCl), which is a multifunctional agent with potent binding and antagonist activity at the 5-HT2A-serotonergic. It is in development as a daily bedtime treatment for fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 13, 2024
Details:
Tonmya (TNX-102 SL) is a sublingual tablet formulation of cyclobenzaprine hydrochloride, which is being evaluated for the treatment of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: Tonmya
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2024
Details:
TNX-102 SL (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated in phase 3 clinical trials for the treatment of Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2024
Details:
Tonix currently intends to use the net proceeds for the preparation of their new drug application relating to TNX-102 SL (cyclobenzaprine hydrochloride) in patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $144.0 million Upfront Cash: $30.0 million
Deal Type: Public Offering December 21, 2023
Details:
Tonmya (cyclobenzaprine HCl) is a 5-HT2 receptor inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2023
Details:
TNX-102 SL (cyclobenzaprine) is a sublingual muscle relaxant which is being evaluated for the treatment & management of fibromyalgia-type long covid.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is investigated for the treatment of management of fibromyalgia-type Long COVID.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2023
Details:
The net proceeds will be used to investigate the potential of Tonix’s TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl, to reduce the frequency and severity of adverse effects of acute trauma.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Department of Defense
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Funding September 27, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is investigated for the treatment of management of fibromyalgia-type Long COVID.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Details:
TNX-102 SL (cyclobenzaprine hydrochloride) is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate which relieves skeletal muscle spasm of local origin without interfering with muscle function.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2023
Details:
TNX-102 SL (cyclobenzaprine hydrochloride) is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate which relieves skeletal muscle spasm of local origin without interfering with muscle function.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Infections and Infectious Diseases Product Name: TNX-102
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, did not achieve statistical significance on the primary endpoint (p=0.115) in a subsequent Phase 3 study (RALLY).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Infections and Infectious Diseases Product Name: TNX-102
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
As expected based on previously reported pre-specified interim analysis results, TNX-102 (cyclobenzaprine HCl ) did not achieve statistical significance on the primary endpoint of reducing fibromyalgia (FM) daily pain at Week 14 compared to placebo in Phase 3 RALLY study.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) did not achieve statistical significance on the primary endpoint of reducing fibromyalgia (FM) daily pain at Week 14 compared to placebo (p=0.115) in the Phase 3 RALLY study.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral hypoaesthesia, a sensory administration site reaction that is typically transient, was never rated as severe, and only lead to one discontinuation.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2021
Details:
The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2021
Details:
Tonix is planning a Phase 3 PTSD study of TNX-102 SL in Kenya, expected to initiate in the third quarter of 2021, and will focus on studying police.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2020
Details:
A poster to be presented includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial evaluating TNX-102 SL for the management of fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2020
Details:
RECOVERY study has stopped enrollment due to inadequate separation from placebo at week-12 based on interim analysis results of the first 50% of enrolled participants.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2020
Details:
Tonix expects the data to satisfy pharmacokinetic requirements for potential New Drug Applications (NDA) for TNX-102 SL for PTSD and Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2020