Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory Depression from Fentanyl and Ultrapotent Opioids
Rhea-AI Summary
Tharimmune (Nasdaq: THAR) received positive FDA feedback on its TH104 (nalmefene buccal film) pharmacokinetic simulation modeling plan following a Type D meeting on Nov 13, 2025. The FDA concurred with the proposed modeling approach and gave technical guidance to incorporate into the final plan, supporting the company's pathway toward a 505(b)(2) NDA. Tharimmune is also initiating a CMC plan to scale production and ensure product quality for advanced development.
PK simulations projected a ~30-minute onset to target concentration and ~24-hour sustained protective levels versus current naloxone effects of 30–90 minutes.
Positive
- FDA concurred with TH104 pharmacokinetic modeling plan
- PK simulation projected ~30-minute time to protective concentration
- Simulations projected ~24-hour sustained protective concentration
- Earlier FDA feedback indicated no additional clinical trials required before 505(b)(2) NDA
- Initiation of CMC plan to scale production and ensure product quality
Negative
- None.
News Market Reaction 18 Alerts
On the day this news was published, THAR declined 6.52%, reflecting a notable negative market reaction. Argus tracked a trough of -26.4% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $8M from the company's valuation, bringing the market cap to $112M at that time.
Data tracked by StockTitan Argus on the day of publication.
Tharimmune announced earlier this month its plans to develop a digital asset treasury strategy that leverages the Canton Coin to support the Canton Network's ability to digitize traditional financial markets.
In a formal Type D meeting with the FDA, Tharimmune presented its initial pharmacokinetic simulation results, and the plan for a more detailed pharmacokinetic modeling, for FDA review. This quantitative modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids. Following its review, the FDA concurred with Tharimmune's proposed modeling plan and provided constructive guidance on specific technical elements, which the Company intends to integrate into the finalized modeling. The FDA's feedback further de-risks the TH104 program and aligns with Tharimmune's development strategy for the planned 505(b)(2) New Drug Application (NDA) submission.
In parallel with this regulatory clarity, the Company is on track to initiate a comprehensive Chemistry, Manufacturing, and Controls (CMC) plan. The initiation of this plan represents a key operational milestone, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product necessary for advanced clinical development and commercial readiness.
The FDA feedback and ongoing CMC planning follow the Company's earlier positive pharmacokinetic (PK) simulation analysis for TH104, which further reinforces its potential as a potentially superior prophylactic treatment for military personnel and chemical incident responders who face high-potency opioid exposure.
The key findings from the simulation analysis demonstrated:
- Rapid Onset: A conservative nalmefene concentration target—representing the threshold effect for protection from respiratory depression—was projected to be achieved in approximately 30 minutes post-dose.
- Sustained Protection: The simulation showed that the protective concentration level could be maintained for about 24 hours.
- Potential Superiority: This prolonged prophylactic window is a potential key advantage over currently available options, such as naloxone injection products, whose effects are typically short-lived (lasting 30-90 minutes). The 24-hour protection window could be crucial in high-risk environments where immediate medical access is limited and sustained prophylaxis is required.
The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient to be self-administered, which may be advantageous for first responders who may be wearing full protective gear. The recent positive feedback earlier this year from the FDA confirming that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application (NDA) submission provides a path forward. Tharimmune is dedicated to advancing TH104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.
About Tharimmune, Inc.
Tharimmune, Inc. (NASDAQ: THAR) is the first publicly traded company to leverage CC and support the Canton Network to advance institutional blockchain adoption and the digitization of financial markets. In addition to driving value through activities on the Canton Network, Tharimmune also operates clinical-stage biotech research and development. For more information, visit: www.tharimmune.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.
Contacts
Media:
Gasthalter & Co.
(212) 257-4170
canton@gasthalter.com
Investors:
ir@tharimmune.com
Twitter/X: @TharimmuneInc
Website: https://tharimmune.com/
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SOURCE Tharimmune, Inc.
FAQ
What did Tharimmune announce about TH104 on November 13, 2025 (THAR)?
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