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TNF Pharmaceuticals Inc. (TNFA) delivers innovative therapeutic solutions through its clinical-stage research in autoimmune and neurological disorders. This dedicated news hub provides investors and industry professionals with essential updates on the company's progress, regulatory developments, and scientific advancements.
Access authoritative reporting on TNFA's two flagship platforms: MyMD-1 for immunometabolic conditions and Supera-CBD targeting neurological therapies. Our curated news collection spans clinical trial milestones, partnership announcements, and research publications, offering comprehensive insights into the company's drug development pipeline.
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TNF Pharmaceuticals (NASDAQ: TNFA) and Renova Health have announced a collaboration leveraging AI and machine learning technologies to enhance drug development for muscle mass preservation during GLP-1 treatment. The partnership analyzes data from 30,000 patients to identify high-risk groups that could benefit from TNF's isomyosamine treatment.
The collaboration utilizes Renova's proprietary AI platform, featuring natural language processing (NLP) and large language models (LLM), to review patient records and identify optimal candidates. The target population includes patients with chronic conditions like diabetes, COPD, chronic kidney disease, or sarcopenia/frailty, who have experienced acute inflammatory events and are taking GLP-1 medications.
This AI-driven approach aims to optimize patient recruitment and accelerate TNF's drug development process, aligning with FDA's recent draft Guidance on AI usage in healthcare.
TNF Pharmaceuticals (NASDAQ: TNFA) presented clinical data for its oral TNF-alpha inhibitor, isomyosamine, at the British Geriatrics Society Spring Meeting 2025. The presentation, delivered by CMO Dr. Mitchell Glass, highlighted the drug's potential in treating sarcopenia in older adults.
Key findings from an earlier Phase 2 study demonstrated:
- Safety and tolerability in elderly patients with sarcopenia
- Significant reductions in inflammatory biomarkers including TNF-α, IL-6, and sTNFR1
The company is currently conducting a larger Phase 2b clinical trial focusing on cellular inflammation and recovery of ambulation speed in elderly patients post-hip fracture. The expanded trial features increased sample size and more frequent dosing to better evaluate clinical and biochemical outcomes. The company also plans to extend Phase 3 trials into the UK and Europe.
TNF Pharmaceuticals (NASDAQ: TNFA) presented positive Phase 2a clinical trial data for its oral TNF-alpha inhibitor drug candidate isomyosamine at the 15th International Conference on Frailty and Sarcopenia Research (ICFSR) in Toulouse, France.
The data demonstrated decreases in biomarkers associated with TNF-α activation in elderly patients with sarcopenia. The company has initiated a Phase 2b clinical trial to evaluate isomyosamine as a treatment for chronic inflammation associated with muscle loss in patients recovering from hip or femur fracture repair surgery.
According to Dr. Mitchell Glass, President and Chief Medical Officer, the presented data supports the rationale for their current Phase 2b study and optimal oral dosing regimen, focusing on isomyosamine's potential for regulating pro-inflammatory cytokines associated with sarcopenia.
TNF Pharmaceuticals (Nasdaq: TNFA) has announced an upcoming investor conference call and webcast scheduled for March 6, 2025, at 4:30 pm ET. The event will feature Dr. Mitchell Glass, President and Chief Medical Officer, who will provide clinical updates on their lead drug candidate isomyosamine.
The company is currently conducting two significant clinical studies:
- A Phase 2b trial evaluating isomyosamine for treating chronic inflammation and muscle loss in hip/femur fracture repair patients
- New studies examining isomyosamine's potential in preserving lean muscle mass during and after GLP-1 weight loss treatments
Isomyosamine is a novel oral TNF-alpha inhibitor targeting immunometabolic dysregulation. Investors can participate via phone (877-407-0832) or webcast, with a 30-day replay available. Questions can be submitted in advance to rschatz@tnfpharma.com.
TNF Pharmaceuticals (NASDAQ: TNFA) has initiated a Phase 2b clinical trial for isomyosamine, their oral TNF-alpha inhibitor drug candidate, targeting chronic inflammation associated with muscle loss in post-surgical hip/femur fracture patients.
The fully funded, randomized, placebo-controlled study at the University of Florida will evaluate 60 patients for up to 90 days post-surgery. The trial builds on previous positive Phase 2a results and aims to explore isomyosamine's efficacy in preventing progressive muscle loss and frailty.
Key advantages of isomyosamine include:
- Oral administration versus current injection/infusion-only options
- Selective TNF-α blocking where overactivated
- Ability to cross blood-brain barrier
- Lower risk of serious side effects compared to traditional treatments
The target market is substantial:
- TNF-alpha inhibitor market: $39.7B (2024), expected to reach $47.3B by 2029
- Sarcopenia affects 10-16% of elderly population
- Sarcopenia treatment market: $3.07B (2024), projected to reach $4.0B by 2029
TNF Pharmaceuticals (NASDAQ: TNFA) has initiated a series of studies to evaluate its oral TNF-alpha inhibitor drug, isomyosamine, for preserving lean muscle mass during GLP-1 weight loss treatment. The studies focus on patients taking Wegovy® or Ozempic®, as up to 40% of total weight loss from GLP-1 treatments comes from lean body mass.
The first study will examine TNF-α levels in GLP-1 patients showing increased inflammation associated with sarcopenia (progressive muscle mass loss). TNF is collaborating with Renova Health, which will utilize its AI and machine learning technology to analyze and identify optimal patient pools and study sites.
The initiative targets the rapidly growing GLP-1 market, valued at $49.3 billion in 2024 and projected to reach $105 billion by 2029, with a CAGR of 19.2% from 2023-2029.
TNF Pharmaceuticals (NASDAQ: TNFA) has partnered with Renova Health to study isomyosamine (MYMD-1) as a treatment for GLP-1-induced sarcopenia and frailty. The fully funded trial will evaluate TNF-α levels in patients using Wegovy or Ozempic who show inflammation associated with sarcopenia.
Studies indicate up to 40% of GLP-1-related weight loss comes from lean body mass, including muscle. If successful, isomyosamine could become a first-in-class therapy for preserving muscle mass during GLP-1 weight loss. The GLP-1 market is valued at $49.3 billion in 2024 and projected to reach $105 billion by 2029.
TNFA is currently conducting a Phase 2 trial for aging-related sarcopenia and plans to launch a Phase 2b study in Q1 2025 following positive Phase 2a results.
TNF Pharmaceuticals (NASDAQ: TNFA) announced significant positive topline results from a Phase 2a study of MYMD-1® (isomyosamine) for sarcopenia treatment. The double-blind, placebo-controlled study in patients aged 65+ showed significant decreases in inflammatory biomarkers, including TNF-α (P=0.008), IL-6 (P=0.03), and sTNFR1 (P=0.02), with no serious adverse events reported.
Based on these results, the company plans to initiate a Phase 2b study in early 2025. The global TNF inhibitor market is valued at $39.7 billion in 2024, expected to reach $47.3 billion by 2029. The sarcopenia treatment market, currently at $3.07 billion, is projected to grow to $4.02 billion by 2029, with over 50 million people affected globally.
TNF Pharmaceuticals (Nasdaq: TNFA) is advancing its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule that blocks excessive TNF-alpha activity to regulate the immuno-metabolic system. The company's next clinical studies will focus on sarcopenia/frailty following statistically significant results from a Phase 2 study.
MYMD-1 met primary endpoints in reducing chronic inflammatory markers with statistical significance in sarcopenia/frailty. The company also holds FDA-cleared Phase 2 INDs for MYMD-1 in rheumatoid arthritis and Hashimoto's thyroiditis. TNFA is preparing to reveal its next steps towards value creation and long-term growth.
TNF Pharmaceuticals, formerly MyMD Pharmaceuticals, has begun trading under its new Nasdaq stock symbol TNFA as of July 24, 2024. This change reflects the company's focus on inhibiting TNF-alpha to regulate the immuno-metabolic system. The company's lead clinical candidate, MYMD-1, blocks excess TNF-α activity, potentially restoring immune system control and regulation.
Dr. Mitchell Glass, President and Chief Medical Officer, emphasized that this rebranding aligns with their core science and highlights MYMD-1's potential as the first TNF-α inhibitor in its indication. The company's CUSIP remains unchanged, and current stockholders need not take any action regarding the symbol change.
