Welcome to our dedicated page for Enlivex Therapeutics news (Ticker: ENLV), a resource for investors and traders seeking the latest updates and insights on Enlivex Therapeutics stock.
Enlivex Therapeutics Ltd. (ENLV) generates news at the intersection of clinical-stage immunotherapy and digital asset treasury management. Company announcements highlight progress in the development of Allocetra™, a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state, and its application in moderate-to-severe knee osteoarthritis. Press releases have detailed positive three- and six-month topline data from the ENX-CL-05-001 Phase I/II trial, including clinically meaningful and statistically significant reductions in pain and improvements in function in age-related primary knee osteoarthritis patients.
Investors following ENLV news will also see updates on Enlivex’s adoption of a digital asset treasury strategy centered on the RAIN token. The company reports that RAIN is the primary asset of its digital asset treasury and describes RAIN as the governance and utility token of a fully decentralized predictions and options protocol built on the Arbitrum network. News items have covered a large private placement intended to fund RAIN token accumulation, an exclusive option agreement to purchase RAIN tokens, and the listing of RAIN on major cryptocurrency exchanges such as KuCoin.
Additional ENLV coverage includes SEC-related disclosures, board and governance changes, shareholder communications, and participation in scientific conferences and investor events. Readers can expect articles on clinical data presentations, new patents related to Allocetra™ in osteoarthritis, shareholder letters outlining strategic roadmaps, and virtual webinars or fireside chats with company leadership and external experts. For those tracking both biotechnology developments in knee osteoarthritis and corporate activity around a RAIN-focused digital asset treasury, the Enlivex news feed provides a consolidated view of the company’s key milestones and strategic decisions.
Enlivex Therapeutics (NASDAQ:ENLV) released a shareholder letter highlighting significant Phase IIa results for Allocetra™ in knee osteoarthritis (KOA) treatment. The trial demonstrated 72% pain reduction versus placebo and 109% function improvement in primary idiopathic age-related osteoarthritis patients aged 60 and above.
The treatment showed particularly strong results in older patients, with efficacy exceeding FDA thresholds for Phase III trials. Allocetra™ was well-tolerated with no drug-related serious adverse events. The company plans to release six-month data in November 2025 and initiate a Phase IIb trial in Q2 2026, focusing on primary KOA patients.
The potential market is significant, with over 32 million Americans affected by KOA, projected to reach 78 million by 2040. Enlivex is pursuing partnership opportunities with larger companies and non-dilutive funding options.
Enlivex Therapeutics (NASDAQ:ENLV) has secured an Israeli patent (No. 290470) for using Allocetra™ to treat osteoarthritis patients, extending protection through 2040. The company recently reported promising Phase IIa results showing significant improvements in knee osteoarthritis patients, including:
- 24% reduction in knee pain and 26% improvement in knee function in the overall modified intention-to-treat population
- 72% reduction in knee pain and 109% improvement in knee function in age-related primary osteoarthritis patients versus placebo
These results demonstrate clinically meaningful and statistically significant effects in common Phase III primary endpoints for knee osteoarthritis trials.
Enlivex Therapeutics (NASDAQ:ENLV) announced positive three-month topline data from its Phase I/II trial of Allocetra™ for moderate-to-severe knee osteoarthritis. The trial demonstrated significant improvements across all efficacy endpoints, with the treatment arm showing a 24% reduction in knee pain and 26% improvement in knee function versus placebo.
Notably, in age-related primary osteoarthritis patients, the results were even more impressive, showing a 72% reduction in knee pain and 95% improvement in knee function compared to placebo - achieving statistically significant effects in common Phase III primary endpoints. The treatment demonstrated a favorable safety profile with no severe adverse events, showing only mild to moderate, transient, and treatable side effects.
Enlivex Therapeutics (Nasdaq: ENLV) announced a webinar scheduled for August 18, 2025, at 8:00 AM ET to present 3-month topline results from its Phase IIa trial of Allocetra™ for moderate to severe knee osteoarthritis. The study, ENX-CL-05-001, is a double-blind, randomized, placebo-controlled multi-center trial.
The trial has enrolled 134 patients who have completed the 3-month follow-up period. The Phase IIa stage follows a completed Phase I open-label dose-escalation study that evaluated safety, tolerability, and optimal dosing. The trial addresses knee osteoarthritis, which affects over 32.5 million Americans and 300 million people worldwide, with 40% of men and 47% of women developing it in their lifetimes.
Enlivex Therapeutics (NASDAQ:ENLV) has confirmed the target date of August 18, 2025 for announcing topline data from its Phase II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. The trial has completed the three-month follow-up period for all 134 patients, marking a significant milestone in the study.
The Phase I/II trial consists of two stages: a Phase I safety run-in, open-label dose escalation phase, followed by a Phase IIa double-blind, randomized, placebo-controlled multi-centered trial. The study's key endpoints include safety assessment and measurement of changes in knee pain and function at three, six, and twelve months post-treatment.
Enlivex Therapeutics (NASDAQ: ENLV) has been selected to present at the Israeli BioMed 2025 Conference in Tel Aviv from May 21-23, 2025. The presentation, titled "Enlivex—Harnessing the Natural Healing Power of Macrophages to Treat Inflammatory Diseases," will focus on their cell therapy product Allocetra™.
Allocetra™ is a universal, off-the-shelf cell therapy designed to reset macrophages to their homeostatic state. The company is currently conducting multiple Phase I/II trials, with promising interim results in moderate knee osteoarthritis showing significant improvements including:
- 47% reduction in pain
- 46% improvement in joint function
- 40% decrease in stiffness
Additional trial readouts are expected in 2025.
Enlivex Therapeutics (Nasdaq: ENLV) announced its participation at the Osteoarthritis Research Society International (OARSI) 2025 World Congress in Incheon, South Korea, scheduled for April 24-27, 2025. The company will present two poster abstracts showcasing their cell therapy product Allocetra™.
The presentations will highlight data from both preclinical and Phase I/II clinical studies of Allocetra™, their proprietary off-the-shelf macrophage reprogramming cell therapy. The therapy has shown promising results in moderate and end-stage osteoarthritis, demonstrating favorable safety profiles, significant pain reduction, improved joint function, and helped patients avoid knee replacement surgery.
Two presentations are scheduled: a Flash Talk & Poster presentation on Phase I/II Clinical Trial results (Abstract #092) and a Poster presentation on Allocetra's biological activity in preclinical models (Abstract #4231304). CEO Dr. Oren Hershkovitz and CMO Dr. Einat Galamidi will be available for meetings during the conference.
Enlivex Therapeutics (Nasdaq: ENLV) has completed patient enrollment in the Phase II stage of its Phase I/II clinical trial evaluating Allocetra™ for moderate to severe knee osteoarthritis treatment. The randomized, controlled, and blinded study successfully enrolled 133 patients. Following promising initial efficacy data from the Phase I stage, the company expects to receive 3-month topline data by August 2025.
Enlivex Therapeutics (Nasdaq: ENLV) has initiated dosing in a Phase I trial evaluating Allocetra™ for temporomandibular joint (TMJ) osteoarthritis patients. The investigator-initiated study, conducted at Sheba Medical Center, aims to assess the safety, tolerability, and initial efficacy of Allocetra™ when injected into the TMJ.
The trial will enroll six patients who have not responded adequately to conventional TMJ osteoarthritis treatments. The study's primary safety endpoint will evaluate adverse events frequency and severity, while efficacy endpoints will measure changes in TMJ pain, joint functionality, and other disease parameters over a 12-month follow-up period.
TMJ osteoarthritis, affecting 5-12% of the global population, is a degenerative and progressive condition causing jaw pain and stiffness, with currently no effective long-term treatments available.
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