Tharimmune Shares Soar 33% as FDA OKs TH104's 505(b)(2) Pathway
By ATTN Desk · Editorial oversight: Sean Han
Introduction
THARIMMUNE INC (Nasdaq: THAR | Ticker: THAR | Name KO: 타이뮨) is a clinical-stage biotechnology company focused on immunology, inflammation, and oncology. As of August 25, 2025, shares were trading at $6.30, reflecting a 33.47 percent increase. The company’s lead asset, TH104, utilizes a transmucosal buccal film to deliver opioid antagonists and is being developed via a 505(b)(2) pathway for the prophylaxis of respiratory or nervous system depression in military personnel and first responders.
Corporate Structure
Headquartered in Bridgewater, New Jersey, THARIMMUNE employs between 11 and 50 people in its public company operations. Since June 2025, Sireesh Appajosyula has served as Chief Executive Officer, supported by a board of directors with experience in biotechnology, pharmaceutical development, and corporate finance. The company has a license agreement with OmniAb, Inc. to utilize its antibody discovery technologies for its early-stage multispecific biologics platform.
Biotechnology by Sangharsh Lohakare
Developments and News
On May 15, 2024, Tharimmune received feedback from the U.S. Food and Drug Administration (FDA) confirming that no additional clinical trials would be required to file a 505(b)(2) New Drug Application for TH104 in the indication of temporary prophylaxis against opioid-induced respiratory or nervous system depression. A Schedule 13D/A filing dated November 27, 2024, indicated that Leonard L. Mazur reported beneficial ownership of 754,295 common shares. A pipeline update as of June 2025 includes:
- Completion of chemistry, manufacturing, and controls (CMC) planning by year-end 2025
- Finalization of stability data in Q4 2025
- Anticipated filing of the TH104 NDA and initiation of a hepatic impairment study in 2026
Financial and Strategic Analysis
As of August 25, 2025, key trading and financial metrics were:
| Metric | Value |
|---|---|
| Share Price | $6.30 |
| 24-Month Volume (Most Recent Day) | 3,774,015 |
| Average Daily Volume (5Y) | 8,023,461 |
| Market Capitalization (Intraday) | $24.90 million |
| Price/Book (MRQ) | 67.79 |
| Net Income (TTM) | –$12.01 million |
| Diluted EPS (TTM) | –6.06 |
| Total Cash (MRQ) | $2.24 million |
| Total Debt/Equity (MRQ) | 90.99 percent |
THARIMMUNE operates without commercial revenues, funding its operations through equity and strategic partnerships. The 505(b)(2) regulatory pathway for TH104 and the collaboration with OmniAb for multispecific antibody discovery are central to its strategy to advance therapeutic candidates and address unmet needs in rare diseases and oncology.
Market Position and Industry Context
In the biotechnology research sector, Tharimmune’s focus on rare immunologic and inflammatory conditions—such as primary biliary cholangitis and opioid-induced respiratory depression—places it in a specialized niche. Its EpiClick™ multispecific biologics platform targets multiple solid tumor epitopes and competes in the broader immuno-oncology landscape alongside established antibody developers. Regulatory designations and a streamlined NDA pathway could facilitate access to orphan or military health markets; however, the company is subject to typical clinical development and funding risks faced by early-stage biotechs.
tl;dr
As of August 25, 2025, THARIMMUNE shares were priced at $6.30, up 33.47 percent. On May 15, 2024, the FDA confirmed that no additional trials are needed for the 505(b)(2) NDA filing for TH104. Key milestones include completion of CMC planning by year-end 2025, finalization of stability data in Q4 2025, and anticipated NDA submission along with the initiation of a hepatic impairment study in 2026.