Fibromyalgia

Virios Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 29, 2024
Fibromyalgia, Research, FDA, Food, Drug development, Conditional sentence, Long COVID, Communication, Therapy, Fatigue, Orthostatic intolerance, Plasma protein binding, Pharmaceutical industry

ATLANTA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • ATLANTA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced financial results for the fourth quarter and full year ended December 31, 2023.
  • General and administrative expenses for the fourth quarter of 2023 remained level with the fourth quarter of 2022 at $0.8 million.
  • As of December 31, 2023, Virios Therapeutics’ cash totaled $3.3 million.
  • The Company believes it has sufficient resources to fund operations into the fourth quarter of 2024.

Virios Therapeutics Issues Shareholder Letter Highlighting Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Wednesday, February 28, 2024
Celecoxib, Fibromyalgia, Letter, Famciclovir, FDA, Management, Food, Conditional sentence, Valaciclovir, Therapy, Research, Pharmaceutical industry

ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.

Key Points: 
  • ATLANTA, Ga., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today issued a Shareholder Letter highlighting the Company’s progress and key milestones in 2024.
  • On behalf of the Virios directors and the executive team, we would like to provide a corporate progress report on several key topics as we proceed through the first quarter of 2024.
  • Approval of this proposal does not commit the Company to the execution of a reverse stock split.
  • The Virios team remains committed to delivering on the promise of combination antiviral therapy to address a multitude of serious health issues and illnesses.

Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China

Retrieved on: 
Tuesday, February 27, 2024
Fibromyalgia, Tonix Pharmaceuticals, Investigational New Drug, New Drug Application, Marketing, Female, Hydrogen chloride, Data, PMDA, Patient, Male, Tablet, IND, NDA, NMPA, CTN, NCE, Pharmaceutical industry

CHATHAM, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.

Key Points: 
  • Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study.
  • The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE).
  • Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.
  • “This bridging study is an important first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China.

NeuroMetrix Reports Q4 and Full Year 2023 Business Highlights

Retrieved on: 
Thursday, February 22, 2024
CIPN, PIN, CMS, Pressure, Absorption, Telephone, FDA, Telehealth, Growth, Peripheral neuropathy, Common, Risk, COVID-19, Medicare, Fibromyalgia, DSM-IV codes, CDC, Long, Prescription, Environment, Baylor University, Pharmaceutical industry

WOBURN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and full year ended December 31, 2023.

Key Points: 
  • WOBURN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and full year ended December 31, 2023.
  • "Quell® Fibromyalgia growth accelerated in Q4 2023 reflecting the addition in Q3 2023 of two field business development managers and optimized clinical messaging.
  • In the successive quarters of Q4 2023 versus Q3 2023, all key operating metrics showed substantial growth.
  • The Q4 2023 net loss was $1.6 million ($1.43 per share) versus a net loss of $0.7 million ($0.73 per share) in Q4 2022.

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 20, 2024
Shift, Acquisition, DSM-IV codes, Fibromyalgia, Central nervous system, Total, New Drug Application, MD, Narcolepsy, FDA, Marketing, Smoking, Food, Somnolence, Growth, SYMPHONY, Reboxetine, Psychiatry, Dextromethorphan/bupropion, Migraine, FOCUS, Safety, Therapy, Medicare, NMDA, CNS, Food and Drug Administration, BED, Webcast, Depression, Binge eating disorder, Patient, Agitation, Shirin David, Medicaid, SWD, Breakthrough therapy, MDD, NDA, Prescription, Pharmaceutical industry

Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.

Key Points: 
  • Auvelity® net product sales were $49.0 million and $130.1 million for the fourth quarter and full year of 2023, the first full year of launch.
  • Total costs of revenue were $7.4 million and $26.1 million for the fourth quarter and full year of 2023, respectively.
  • Approximately 84,000 prescriptions were written for Auvelity in the fourth quarter of 2023, representing a 23% sequential increase versus the third quarter of 2023.
  • Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss fourth quarter and full year 2023 financial results as well as to provide a corporate update.

Tonix Pharmaceuticals to Participate in the 2024 BIO CEO & Investor Conference

Retrieved on: 
Tuesday, February 20, 2024
Infection, Therapy, Fibromyalgia, TNX-102, Tonix Pharmaceuticals, Orphan drug, Smallpox, NIAID, Research, Annual report, NIH, CD40L, FDA, BIO, Prader–Willi syndrome, Sumatriptan, Government, Upsher-Smith Laboratories, Conference, Disease, Autoimmunity, University, COVID-19, PWS, Patient, Acute stress disorder, Security (finance), Long, Breakthrough therapy, Risk, IND, NDA, Failure, Long COVID, Cancer, Pharmaceutical industry

CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.

Key Points: 
  • CHATHAM, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present at the BIO CEO & Investor Conference on February 26, 2024 at 1:30 p.m.
  • Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
  • Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024.
  • A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024.

New to The Street Airs Episode 556 Featuring Five Corporate Interviews, Broadcast on the FOX Business Network Monday, February 19, 2024, at 10:30 PM PT

Retrieved on: 
Friday, February 16, 2024
Carbon, Hospital, Watt, Mining, News, Somnolence, DNX, Bacteria, FINRA, Global X ETFs, Patient, Corporation, BTC, POW, Biopharmaceutical, Television, Carbon footprint, Pain, Wind, CDI, Vancomycin, Fox Business, Ecosystem, SBP, Interview, Miner, Partnership, Woman, Nursing, Sleep, ESG, Insomnia, Business, Decentralization, EnergySolutions, Fibromyalgia, Tonix Pharmaceuticals, MD, Sustainability, FDA, Patent, SBC, Food, Tongue, United States patent law, Medicine, Headache, Publication, Cryptocurrency

New to The Street's Episode 556 line-up features the following five (5) Corporate interviews:

Key Points: 
  • New to The Street's Episode 556 line-up features the following five (5) Corporate interviews:
    2).
  • Tonix's new drug, called Tonmya™, is a new class of medicine that controls pain in those who have fibromyalgia.
  • Fibromyalgia is common in women who have been unsuccessful in finding current marketplace drugs limited in the treatment success.
  • Clinical studies have shown that Tonmya™ can eliminate most pain, enhance sleep, and diminish fatigue in patients.

Sterilization Facilities Sued Over Puerto Rico Ethylene Oxide Emissions

Retrieved on: 
Wednesday, February 14, 2024
Legal, Environment, Hispanic, Chemicals, Plastics, Environmental Health, Professional Services, Consumer, Manufacturing, Fibromyalgia, Pollutant, Atmosphere, Spina bifida, Commonwealth, Plant, Asthma, Ethylene oxide, Concerned Scientists, Health, PLLC, Union, United States district court, EPA, Sterilization, Cancer

Attorneys for Milberg Coleman Bryson Phillips Grossman, PLLC (“Milberg”), Napoli Shkolnik, and Kresch Legal Services PR, PLLC have filed an amended proposed class action complaint on behalf of Puerto Rico residents who claim they were injured by ethylene oxide (EtO) emissions from sterilization facilities located in the Commonwealth.

Key Points: 
  • Attorneys for Milberg Coleman Bryson Phillips Grossman, PLLC (“Milberg”), Napoli Shkolnik, and Kresch Legal Services PR, PLLC have filed an amended proposed class action complaint on behalf of Puerto Rico residents who claim they were injured by ethylene oxide (EtO) emissions from sterilization facilities located in the Commonwealth.
  • Ethylene oxide is a colorless gas emitted by plants that use it to sterilize medical equipment and produce chemicals.
  • Emissions are alarmingly prevalent in Puerto Rico, where there are seven sterilizer plants, including four of the most dangerous facilities, according to a report from the Union of Concerned Scientists.
  • The report found that roughly 13% of Puerto Rico’s neighborhoods are impacted by the release of EtO from medical facilities.

Silo Pharma’s SP-26 Ketamine Implant Demonstrates Successful Drug Delivery

Retrieved on: 
Wednesday, February 14, 2024
IDDS, Therapy, Fibromyalgia, Blood, Ketamine, Administration, Chronic pain, HCL, SILO, Medical device

SARASOTA, FL, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today provided a positive update on SP-26, its novel time-released, dose-controlled formulation of ketamine initially targeted for fibromyalgia. A pre-clinical research study is underway involving analytical testing services and small batch proof-of-concept extrusion trials to determine drug release and stability.

Key Points: 
  • A pre-clinical research study is underway involving analytical testing services and small batch proof-of-concept extrusion trials to determine drug release and stability.
  • In recent testing, SP-26 polymer implants were blended with ketamine hydrochloride (ketamine HCL) in two loadings, 20% and 40%.
  • “Implantable drug delivery systems like SP-26 may provide sustained drug delivery for prolonged periods of time, which is critical for the treatment of chronic pain conditions,” said Eric Weisblum, CEO of Silo.
  • Silo believes that implantable drug delivery systems (IDDS) can offer a superior delivery alternative for sustained relief from chronic pain.

Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024

Retrieved on: 
Wednesday, February 14, 2024
Fibromyalgia, Tonix Pharmaceuticals, FDA, Pain, Food, Sleep, Behavioral neuroscience, Hope, Hydrogen chloride, University, Fatigue, Patient, University of Cincinnati, University of Michigan, Psychiatry, Tablet, NDA, KOL, Pharmaceutical industry

CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, held a key opinion leader (KOL) webinar to discuss the positive Phase 3 data of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, and the path to file for FDA approval in the second half of 2024. The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).

Key Points: 
  • The webinar was held on January 31, 2024 and hosted by Alliance Global Partners (A.G.P.).
  • As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya™ for the management of fibromyalgia.
  • “We are now an important step closer to bringing a new, first-line treatment to fibromyalgia patients that offers broad symptom relief and favorable tolerability for chronic use and adherence.”