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 (ENLV) news coverage tracks developments from this Israeli clinical-stage immunotherapy company as it advances Allocetra through clinical trials. As a biotechnology firm focused on immune system rebalancing, Enlivex generates news primarily around clinical trial milestones, regulatory interactions, and corporate financing activities.
For biotech investors following Enlivex, the most consequential news typically involves clinical data readouts—interim and topline results from trials evaluating Allocetra in osteoarthritis, sepsis, and other indications. Trial enrollment completions, dosing milestones, and conference presentations also drive significant interest. Positive efficacy signals can substantially impact valuation, while safety concerns or trial failures carry downside risk.
Beyond clinical developments, Enlivex news includes financing announcements common to pre-revenue biotechs—private placements, public offerings, and strategic transactions that fund ongoing operations. Patent filings and intellectual property developments provide insight into the company's competitive positioning and protection of its technology platform.
As a foreign private issuer headquartered in Israel, Enlivex may also generate news related to international partnerships, regulatory pathways in multiple jurisdictions, and governance matters. Board appointments and strategic advisors sometimes signal shifts in corporate direction or therapeutic focus areas.
Bookmark this page to follow Enlivex Therapeutics news as clinical programs progress. Understanding the timing of expected data readouts and the significance of different trial phases helps contextualize individual announcements within the broader development timeline.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced that ANSES and FAMHP approved the amended protocol for its Phase II trial of Allocetra™ in sepsis patients. The study's scope expands to include septic patients from biliary, urinary tract, or abdominal infections. The trial will enroll 80 to 160 participants across four cohorts, assessing safety and efficacy over 28 days. Previous Phase Ib results indicated improved clinical outcomes with Allocetra™ compared to standard care. CEO Oren Hershkovitz highlighted this regulatory achievement as validation of the trial's design.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced FDA clearance for its frozen-formulation Allocetra™ IND aimed at treating patients with advanced solid tumors. The IND includes a multi-center clinical trial in Israel, evaluating Allocetra™ alone and with a PD1 checkpoint inhibitor. Notable preclinical data showed a 55% survival rate in combination therapy for a mesothelioma model. The company also received regulatory approvals in Europe for amendments to its Phase II sepsis trial, expanding the patient population. As of September 30, 2022, Enlivex reported a net loss of $5.7 million and cash reserves of $57.7 million.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has announced that the FDA approved its Investigational New Drug (IND) application to study its cell therapy, Allocetra™, in patients with advanced solid tumors. This IND clearance follows positive preclinical studies in collaboration with Yale Cancer Center, showing significant survival benefits in murine models. The Phase I/II clinical trial aims to evaluate Allocetra™ alone and in combination with PD1 checkpoint inhibitors for patients with relapsed or refractory malignancies. This regulatory clearance marks a pivotal milestone in Enlivex's development trajectory.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) has initiated a Phase I/II clinical trial for Allocetra™, targeting advanced solid tumor patients. This multi-center trial aims to assess the safety, tolerability, and preliminary efficacy of Allocetra™ as both monotherapy and in combination with the PD1 checkpoint inhibitor. The trial builds on promising preclinical results that indicated significant survival benefits in murine models. The trial will enroll up to 48 patients, evaluating different dosing strategies to monitor impacts on overall survival and immune profiling.
Enlivex Therapeutics (Nasdaq: ENLV) announced a poster presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer from November 8-12, 2022, in Boston. The presentation titled “Synergistic anti-tumor effect of Allocetra–OTS, a cellular immune-therapy” is scheduled for November 10 and 11. Enlivex focuses on immunotherapy with its product Allocetra™, designed to reprogram macrophages to enhance immune response against cancer. For conference registration, visit the provided link.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation at the 4th Macrophage-directed Therapies Summit in Boston from October 4-6, 2022. The company's presentation is scheduled for October 6 at 2:30 PM ET, where management will discuss clinical programs targeting sepsis and solid cancers, along with supporting data. The summit will cover strategies to enhance macrophage therapies and facilitate discussions on clinical applications. Interested parties can register for the event here.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced its participation in multiple investor conferences in September 2022. The company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 11:00 AM ET, and at Baird’s 2022 Global Healthcare Conference on September 14, 2022, at 3:10 PM ET. Additionally, Enlivex will engage in a panel discussion at the Cantor Cell and Genetic Medicines Conference on September 15, 2022, at 9:20 AM ET. Management will also be available for one-on-one meetings during these events.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced significant preclinical data at the ESMO Congress 2022, demonstrating that the combination of Allocetra™ with cisplatin resulted in a 55% survival rate in a murine mesothelioma model, compared to 0% in untreated and cisplatin monotherapy groups. These results support the ongoing Phase I/II trial of Allocetra™ combined with chemotherapy for patients with peritoneal metastases from solid tumors. Allocetra™ aims to reprogram macrophages to enhance anti-cancer responses.
Enlivex Therapeutics (Nasdaq: ENLV) announced on Sept. 6, 2022, that it received a Notice of Allowance from the U.S. Patent and Trademark Office for patent application 15/551,284. This patent will enhance the company's intellectual property protection for Allocetra™, extending through at least 2036. Allocetra™ is aimed at inhibiting cytokine release syndrome in CAR T-cell therapy patients. The patent is expected to be granted by Q1 2023. CEO Oren Hershkovitz emphasized the significance of this patent in broadening Enlivex's valuable IP portfolio.
Enlivex Therapeutics Ltd. (Nasdaq: ENLV) announced the issuance of a Notice of Allowance from the Japanese Patent Office for patent application number 2020-198242. This patent will grant intellectual property protection for the use of pooled donor cells in Allocetra™, extending protection until at least 2037. Enlivex aims to bolster its global IP strategy to enhance the commercial potential of Allocetra™, a reprogramming immunotherapy targeting diseases like sepsis and solid tumors. The patent is expected to be issued in Q2 2023, emphasizing Enlivex’s commitment to addressing unmet medical needs.
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