Hepion Pharmaceuticals reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
Hepion Pharmaceuticals (HEPA) reported FDA feedback and simulations predicting GV104 protection against fentanyl-induced cardiac arrest ahead of potential opioid exposure. Across 200 virtual subjects and all fentanyl doses modeled, a single 16 mg film taken at least 15 minutes before exposure prevented every simulated cardiac arrest. At the highest modeled dose, 86.5 percent of untreated simulated subjects were expected to develop cardiac arrest. Predicted median onset was 10–15 minutes, versus roughly 30 minutes initially estimated in 2025.
The FDA reaffirmed the overall approach and requested modeling revisions. Hepion believes it can address the comments within its existing program and plans a prompt response; predicted protection may change. Manufacturing development remains principal pre-filing work, with commercial-scale registration batches planned to begin in 2027.
Hepion Pharmaceuticals (HEPA) received FDA written feedback through subsidiary Gravitas Life Sciences on its planned GV104 program for gambling disorder. The FDA outlined requirements for a 505(b)(2) application, a route allowing partial reliance on prior findings for an approved nalmefene product, and permitted cross-referencing an earlier investigational new drug application (IND) for nonclinical and manufacturing information.
The FDA said existing nonclinical studies appear potentially sufficient for 12-week dosing and the planned Phase 2 design is generally appropriate, including its proposed primary severity assessment. Hepion anticipates filing a full IND in 2027; trial design remains subject to revisions and IND review. The FDA also outlined additional nonclinical data expected for a marketing application. GV104 is intended to be studied alongside psychosocial care for gambling disorder, which has no approved medication.
Hepion Pharmaceuticals (HEPA) completed its acquisition of Gravitas Life Sciences on October 6, 2026, adding two licensed therapeutic programs. Gravitas is now a wholly-owned subsidiary. GV104 is a clinical-stage opioid-antagonist buccal film; GV023 is an oral infliximab formulation not yet tested in humans.
Hepion plans to complete GV104 manufacturing development and begin commercial-scale registration batches in 2027, a prerequisite for FDA-identified studies and a drug approval application. It also intends to seek regulatory guidance in 2027 for a first-in-human GV023 study in Australia or the European Union. Its circulating tumor RNA diagnostic would be offered as a laboratory-developed test only after successful validation.
On October 9, 2026, the board appointed former Gravitas CEO Sireesh Appajosyula as Hepion CEO and former interim CEO Gary Stetz as CFO.
Hepion Pharmaceuticals (OTCQB:HEPA) in‑licensed a novel circulating tumor RNA (ctRNA) biomarker assay from Cirna Diagnostics to aid early diagnosis and surveillance of hepatocellular carcinoma (HCC) in high‑risk patients, announced March 3, 2026.
The license includes potential extension rights beyond HCC, complements Hepion’s mSEPT9 methylated DNA assay, and the company plans CLIA partnerships, pharma companion diagnostic collaborations, and later co‑development/commercialization steps.
Hepion Pharmaceuticals (OTCQB:HEPA), a clinical stage biopharmaceutical company, has announced its successful transition to the OTCQB Venture Market. The company's common stock commenced trading on the OTCQB on June 25, 2025, under the symbol HEPA.
Hepion focuses on developing and commercializing diagnostic tests for multiple conditions including celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori, and hepatocellular carcinoma (HCC).
Hepion Pharmaceuticals (NASDAQ:HEPA) has received a delisting notification from Nasdaq on May 9, 2025. The company's stock will be suspended from trading on Nasdaq effective May 13, 2025, and is expected to transition to trading on the OTC Markets Group under the symbol "HEPA". The delisting is due to two main compliance failures: not maintaining a minimum bid price of $1.00 per share (Rule 5550(a)(2)) and Nasdaq's determination that the company is a public shell (Rule 5101).
Notably, Hepion has undergone a significant business transformation from a clinical stage biopharmaceutical company developing NASH, HCC, and liver disease treatments to becoming a developer and distributor of diagnostic tests for celiac disease, respiratory multiplex, H. pylori, and HCC.
Hepion Pharmaceuticals (NASDAQ:HEPA) has signed a binding letter of intent with New Day Diagnostics LLC to in-license diagnostic tests for multiple conditions. The agreement covers tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and hepatocellular carcinoma (HCC).
The combined addressable market for these diagnostics exceeds $15 billion, with individual markets showing significant growth potential: Respiratory Panel ($5.6B market, 6.6% annual growth), H. pylori detection ($700M market, 6.0% growth), CeliaCare ($457M market, 10.4% growth), and mSEPT9 for HCC ($8.7B market, 6.7% growth). The celiac, respiratory multiplex, and H. pylori tests already have CE marks and can be sold in Europe through New Day's existing distributor network.
Hepion Pharmaceuticals (NASDAQ: HEPA) has announced a 1-for-50 reverse stock split, effective March 17, 2025, at 4:01 p.m. Eastern Time. The company's shares will begin trading on a split-adjusted basis on March 18, 2025, maintaining its NASDAQ symbol 'HEPA' with a new CUSIP number 426897 401.
The reverse split aims to increase the bid price to meet NASDAQ's $1.00 minimum bid requirement for continued listing. This corporate action will reduce outstanding shares from approximately 54.25 million to 1.08 million. Stockholders approved this measure at the annual meeting on March 10, 2025.
The split will automatically combine every 50 shares into one share, with fractional shares rounded up to the next whole share. This action will not affect stockholders' ownership percentages or voting power, except for minimal changes due to fractional share treatment. Proportionate adjustments will be made to stock options, incentive plans, and outstanding warrants.
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced a $9.0 million public offering of 27,692,310 shares of common stock or pre-funded warrants. Each share or warrant comes with two common warrants: a series A and series B, both with an exercise price of $0.40 per share.
The combined offering price is $0.325 per common stock unit and $0.3249 for pre-funded warrant units. The proceeds will be used to repay certain debt and for general corporate purposes, including working capital, operating expenses, and capital expenditures.
The offering, managed by sole placement agent Laidlaw & Company (UK), is expected to close around January 23, 2025. The offering is made pursuant to an effective registration statement on Form S-1 and a related registration statement filed under Rule 462(b).