Trevi Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
TRVI$15.31+6.8%Stored close · as of Nov 9, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-338023
Item 1A. Risk FactorsOther InformationCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001193125-26-453674
Item 1A. Risk FactorsOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 16 previous paragraphs and 15 current paragraphs.
11 unchanged; 4 reworded; 0 added; 0 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Reworded paragraphs (4)
Previous wording
Our business is subject to numerous risks. The following important factors, among others, could cause our actual results to differ materially from those expressed in forward-looking statements made by us or on our behalf in this Quarterly Report on Form 10-Q and other filings with the Securities and Exchange Commission, or SEC, press releases, communications with investors and oral statements. Actual future results may differ materially from those anticipated in our forward-looking statements. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Current wording
Our business is subject to numerous risks. The following important factors, among others, could cause our actual results to differ materially from those expressed in forward-looking statements made by us or on our behalf in this Quarterly Report on Form 10-Q and other filings with the SEC, press releases, communications with investors and oral statements. Actual future results may differ materially from those anticipated in our forward-looking statements. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Previous wording
If Haduvio is approved for the treatment of chronic cough in patients with IPF and non-IPF ILD, we expect that it may compete with product candidates that may be developed for the treatment of chronic cough in patients with IPF or ILD. Development of BI 1839100, a TRPA1 antagonist by Boehringer Ingelheim for the treatment of IPF-related chronic cough and progressive pulmonary fibrosis, was terminated in September 2025. It is possible that product candidates currently in development for the treatment of fibrosis in patients with IPF and ILD could, if approved, reduce the need for therapies to treat chronic cough in patients with IPF and non-IPF ILD. We expect that Haduvio might also compete with other product candidates currently in development, for the treatment of patients with RCC that might be used off-label to treat IPF-related chronic cough.
Current wording
If Haduvio is approved for the treatment of chronic cough in patients with IPF and non-IPF ILD, we expect that it may compete with product candidates that in the future may be developed for the treatment of chronic cough in patients with IPF or ILD. It is possible that product candidates currently in development for the treatment of fibrosis in patients with IPF and ILD could, if approved, reduce the need for therapies to treat chronic cough in patients with IPF and non-IPF ILD. We expect that Haduvio might also compete with other product candidates developed in the future, for the treatment of patients with RCC that might be used off-label to treat IPF-related chronic cough.
Previous wording
If Haduvio is approved for the treatment of patients with RCC, we expect that it may compete with product candidates in clinical development for the treatment of patients with RCC. Gefapixant, a P2X3 antagonist, which was developed by Merck & Co., Inc., or Merck, is approved for refractory or unexplained chronic cough in Japan, the United Kingdom, Switzerland, and the E.U. The application filed with the FDA was withdrawn and Merck indicated it does not plan to refile. Camlipixant, a P2x3 antagonist, which was being developed by GSK plc., will not progress further with development in RCC as of July 2026. Other product candidates that are currently in development for the treatment of patients with RCC include taplucainium (formerly NTX-1175), a charged sodium channel blocker, which is being developed by Nocion Therapeutics Inc.
Current wording
If Haduvio is approved for the treatment of patients with RCC, we expect that it may compete with product candidates in clinical development for the treatment of patients with RCC. Gefapixant, a P2X3 antagonist, which was developed by Merck & Co., Inc., or Merck, is approved for refractory or unexplained chronic cough in Japan, the United Kingdom, Switzerland, and the E.U. The application filed with the FDA was withdrawn and Merck indicated it does not plan to refile. Camlipixant, a P2X3 antagonist, which was being developed by GSK plc., failed its Phase 3 program and GSK plc announced it would not progress further with development in RCC as of July 2026.
Previous wording
During the three months ended June 30, 2026, Jennifer Good, the Company's Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement for the sale of common stock issuable upon the exercise of certain stock options held by Ms. Good. The trading agreement is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act. The stock options subject to this arrangement are scheduled to expire on December 20, 2027. This plan was adopted on June 11, 2026 and has an expiration date of December 31, 2026. Pursuant to the plan, the aggregate number of shares for which such options are to be exercised, and the aggregate number of shares of common stock to besold upon exercise of those options, is not to exceed 173,684.
Current wording
During the three months ended September 30, 2026, Farrell Simon, the Company's Chief Commercial Officer, adopted a Rule 10b5-1 trading arrangement for the sale of common stock issuable upon the exercise of certain stock options held by Dr. Simon. The trading arrangement is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act. This plan was adopted on August 11, 2026 and has an expiration date of December 31, 2027. Pursuant to the plan, the aggregate number of shares for which such options are to be exercised, and the aggregate number of shares of common stock to besold upon exercise of those options, is not to exceed 81,553.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
During the three months ended June 30, 2026, Michael Heffernan, adirector of the Company, adopted a Rule 10b5-1 trading arrangement for the sale of common stock issuable upon the exercise of certain stock options held by Mr. Heffernan. The trading arrangement is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act. The stock options subject to this arrangement are scheduled to expire on February 27, 2027 and December 20, 2027, respectively. This plan was adopted on June 16, 2026 and has an expiration date of December 31, 2027. Pursuant to the plan, the aggregate number of shares for which such options are to be exercised, and the aggregate number of shares of common stock to besold upon exercise of those options, is not to exceed 39,473.