- Tivic Health Systems (TIVC) stock surged 230% in early trading Tuesday after briefings with White House and FDA leadership on April 17, highlighted strong interest in its Entolimod and ncVNS programs for military and defense applications.
- Entolimod, a TLR5 agonist for acute radiation syndrome, and ncVNS, targeting inflammatory and neurologic disorders, position Tivic to address critical health needs for military personnel and civilians, with ongoing FDA discussions signaling potential expedited approvals.
Tivic Health Systems (TIVC) stock soared 230% in early trading Tuesday, driven by positive feedback from briefings with senior White House and FDA leadership on April 17. The discussions highlighted significant interest in the military and defense applications of Tivic’s biologic and bioelectronic product candidates, particularly Entolimod and its non-invasive cervical vagus nerve stimulation (ncVNS) program. Jennifer Ernst, CEO of Tivic, emphasized the potential of these technologies to protect and heal active and retired military personnel, first responders, U.S. citizens, and allies, noting that while the meetings were informal, further discussions are anticipated.
Entolimod, a late-stage Toll-like Receptor 5 (TLR5) agonist, is designed to treat acute radiation syndrome (ARS) by enhancing immune responses, with a single dose demonstrating protective effects on gastrointestinal and hematopoietic systems in preclinical studies. Its FDA Fast Track and Orphan Drug designations underscore its strategic importance, particularly for defense scenarios involving radiation exposure. Tivic’s ncVNS program, meanwhile, focuses on non-invasive medical devices that personalize vagus nerve stimulation to address inflammatory, cardiac, and neurologic disorders, including post-traumatic stress disorder (PTSD), which is of particular interest to military organizations.
The U.S. government’s prior funding through agencies like BARDA, NASA, and the Department of Defense for Entolimod’s development signals strong institutional support. Tivic’s dual-platform approach, combining bioelectronic and biologic therapies, positions it to address immune and autonomic dysregulation through neural and molecular pathways. The FDA discussions also explored expedited approval pathways for Entolimod and its derivative, Entalasta, enhancing Tivic’s regulatory prospects. With a $5.2 billion ARS market projected to grow 5% annually through 2031, Tivic’s advancements could reshape therapeutic options for defense and civilian applications, driving investor optimism and the stock’s dramatic surge.
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