Welcome to our dedicated page for Tivic Health Systems news (Ticker: TIVC), a resource for investors and traders seeking the latest updates and insights on Tivic Health Systems stock.
Tivic Health Systems, Inc. (Nasdaq: TIVC) generates news that reflects its evolution into a diversified immunotherapeutics and health technology company. This page aggregates coverage of Tivic’s progress in biologics, bioelectronic medicine and contract development and manufacturing, giving investors and observers a single place to review its latest corporate announcements.
Much of Tivic’s recent news flow centers on Entolimod™, its lead Toll-like Receptor 5 (TLR5) agonist drug candidate for acute radiation syndrome (ARS) and related conditions. Articles highlight milestones such as cell line verification, large-scale manufacturing runs, and steps toward current Good Manufacturing Practice (cGMP) production in preparation for a potential Biologics License Application (BLA). Releases also discuss Entolimod’s Fast Track and Orphan Drug designations, its development under the FDA’s Animal Rule, and animal data showing effects on survival, gastrointestinal recovery and hematopoiesis after radiation exposure.
Another major theme in Tivic news is its acquisition of manufacturing and development assets and the launch of Velocity Bioworks™, a wholly owned CDMO subsidiary. Coverage describes how Velocity Bioworks is expected to support Tivic’s own biologics pipeline and offer development and manufacturing services to third-party biotech companies, creating additional revenue opportunities and reducing reliance on external manufacturers.
Visitors will also find updates on Tivic’s bioelectronic program, including results from a clinical optimization trial of non-invasive cervical vagus nerve stimulation conducted with The Feinstein Institutes for Medical Research at Northwell Health. These stories detail how personalized stimulation parameters can influence autonomic measures such as heart rate variability.
In addition, Tivic regularly reports on its interactions with government and industry stakeholders, including BARDA TechWatch meetings, participation in the Military Health System Research Symposium, and conference presentations outlining its strategic transformation. For investors tracking TIVC, this news feed offers a consolidated view of clinical, manufacturing, partnership and capital markets developments.
Tivic Health Systems (Nasdaq:TIVC) received a formal Request for Information from the Ukrainian Ministry of Health on March 31, 2026, to evaluate Entolimod for potential inclusion in Ukraine's national strategic reserves against Acute Radiation Syndrome (ARS).
The ministry also requested a pre-submission meeting. Tivic highlighted Entolimod's selective TLR5 mechanism that protects bone marrow and GI tissues, its potential in oncology supportive care, planned physician-sponsored trials later in 2026, and recent U.S. TechWatch meetings with BARDA on Jan 26 and Mar 10, 2026.
Tivic Health (Nasdaq:TIVC) announced that CEO Michael K Handley will present at the Emerging Growth Virtual Conference on April 1, 2026 from 2:55–3:05 PM ET.
The presentation will highlight recent milestones, notably a NIAID agreement to sponsor a preclinical study of Entolimod for gastrointestinal acute radiation syndrome (GI-ARS); NIAID may support future GI-ARS studies if the data demonstrate efficacy. A live webcast and archived replay are available; registration is required.
Tivic Health (Nasdaq:TIVC) entered an agreement with NIAID to sponsor preclinical studies of Entolimod for gastrointestinal acute radiation syndrome (GI-ARS), with the first study at AFRRI.
NIAID will fund studies starting in mouse models and may advance to non-human primates, aiming to support an FDA Animal Rule path and a targeted BLA submission. Entolimod is a TLR5 agonist that may protect GI tissue versus existing hematopoietic-focused ARS therapies.
Tivic (NASDAQ:TIVC) completed a strategic transformation into an immunotherapy company centered on Entolimod and next-generation Entolasta, acquiring exclusive global rights and related development assets.
The company formed Velocity Bioworks CDMO, relocated headquarters to San Antonio, discontinued ClearUP consumer operations, and engaged U.S. government agencies for potential funding. 2025 operating expenses rose to $7.9M and cash totaled $12.6M at year-end.
Tivic Health Systems (Nasdaq:TIVC) announced a strategic pivot to focus solely on its TLR5 biopharma platform, centering on Entolimod and second-generation Entolasta. The company discontinued commercial sales of the ClearUP sinus device and suspended the non-invasive vagus stimulation program to concentrate resources on oncology supportive care and ARS preparedness.
Manufacturing progress includes a reported 200-fold scale-up of Entolimod using 50-liter fermentation via Velocity Bioworks, its CDMO. Tivic said it is pursuing BARDA funding and allied-government stockpiling while exploring injectable and oral formulations. A year-end update will follow on March 25 with the Form 10-K filing.
Tivic Health Systems (Nasdaq:TIVC) will report its 2025 year-end financial results via a pre-recorded conference call and webcast on Wednesday, March 25, 2026 at 1:30 PM PT / 4:30 PM ET. Participants may join by dial-in or live webcast. An audio replay will be available for 90 days on the company investor website.
Dial-in details and the webcast link are provided for investor access and replay.
Tivic Health Systems (Nasdaq:TIVC) appointed Michael K. Handley as CEO effective March 4, 2026, marking a strategic shift toward late-stage immunotherapies and biopharma.
The company will expand commercialization focus and integrate contract biomanufacturing via new subsidiary Velocity Bioworks, with founder Jennifer Ernst transitioning from the CEO role to support the change.
Tivic (Nasdaq:TIVC) announced a follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) on March 10, 2026 to continue discussions about clinical data, potential funding, and possible stockpiling of Entolimod for Acute Radiation Syndrome (ARS).
Entolimod, a TLR5 agonist, has shown improved survival and gastrointestinal and hematopoietic protection in animal studies under the FDA Animal Rule; Tivic also highlighted manufacturing readiness via its new biomanufacturing subsidiary Velocity Bioworks.
Tivic (Nasdaq:TIVC) presented Entolimod at a TechWatch meeting with BARDA and U.S. defense and health agencies on January 26, 2026. The company showcased clinical results and manufacturing readiness accelerated by new subsidiary Velocity Bioworks, and BARDA requested an expedited follow-up to continue discussions about potential inclusion in the Strategic National Stockpile.
The meeting started formal engagement with BARDA, DoD, DTRA, NIH and NIAID to evaluate Entolimod as a therapeutic and prophylactic radiation medical countermeasure.
Tivic Health (Nasdaq:TIVC) will present at the 3rd Annual DealFlow Discovery Conference on Jan 28-29, 2026 in Atlantic City. The CEO's presentation will outline a strategic pivot and forward outlook for advancing Entolimod™ toward commercialization.
Key topics include cell line verification success, a demonstrated 200x manufacturing scale-up with reproducible quality, progress toward cGMP manufacturing in preparation for a Biologics License Application (BLA), engagement with BARDA via a Jan 26 TechWatch meeting, and the formation/integration of Velocity Bioworks, an internal CDMO aimed at accelerating commercial readiness.