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) 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.
Tivic Health (NASDAQ:TIVC) announced that CEO Jennifer Ernst will present a corporate update at the Emerging Growth Virtual Conference on January 22, 2026 at 4:10–4:20 PM ET. The presentation will cover recent milestones in advancement of Entolimod, including scale-up validation for manufacturing and the vertical integration of Velocity Bioworks, a San Antonio contract development and manufacturing organization.
The company said the Velocity Bioworks addition provides in‑house manufacturing capability and potential new revenue streams, and is expected to reduce production costs, eliminate outsourcing delays, and accelerate cGMP validation for Entolimod. A live webcast and archived replay will be available.
Tivic Health (Nasdaq:TIVC) announced a 200x manufacturing scale-up for lead drug candidate Entolimod, completed by its wholly owned CDMO, Velocity Bioworks. Tivic validated a 50‑liter production batch equivalent to ~1.3 million human doses with purity, potency and yields meeting release criteria. The company said the acquisition of CDMO assets improved operational and cost efficiencies and expects to advance to 200 liters under cGMP as the next step toward a Biologics License Application (BLA) for Acute Radiation Syndrome (ARS). Tivic also noted an upcoming BARDA TechWatch meeting on January 26, 2026 to discuss strategic relevance.
Tivic Health (Nasdaq: TIVC) will host a special webcast and conference call on Monday, January 12, 2026 at 1:30 PM PT / 4:30 PM ET to discuss its December 2025 acquisition of certain CDMO assets, now branded Velocity Bioworks. Management said the in‑house CDMO has already reduced outsourcing delays and costs, accelerated validation of Entolimod™ manufacturing, and may enable an earlier biologics license application submission to the U.S. FDA. Leadership expects Velocity Bioworks to operate as a standalone CDMO and a new revenue engine by providing biologic production services to small and midsize development-stage biotech companies. The call will feature CEO Jennifer Ernst and COO Michael K. Handley and is accessible via webcast and dial-in.
Tivic (Nasdaq:TIVC) acquired cGMP manufacturing and development assets from Scorpius and launched Velocity Bioworks, a wholly owned CDMO subsidiary, to accelerate commercialization of Entolimod and serve third-party biotech customers. The company validated the Entolimod cell line at the site in Q3 and says the facility supports a BLA pathway.
Financing led by 3i, LP includes $16M debt for the asset purchase, up to $75M in preferred convertible equity (including an $18M near-term tranche), and an expected $50M equity line of credit affiliate facility.
Tivic Health (NASDAQ:TIVC) announced it secured an exclusive BARD A Techwatch meeting on November 18, 2025 to present clinical and manufacturing data for Entolimod for acute radiation syndrome (ARS).
The company said it will discuss Entolimod's animal-rule survival and organ-recovery data, manufacturing readiness, and preparations toward a biologics license application (BLA). Entolimod has FDA Fast Track and Orphan Drug designations and is being considered for mass-casualty stockpile and field deployment pathways that could lead to BARDA evaluation for funding or procurement.