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Form SCHEDULE 13D Hepion Pharmaceuticals, Filed by: Gravitas Collective Corp.

Mon, 26 Oct 2026 20:00:00 -0400

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Hepion gets FDA feedback on opioid-overdose prevention drug GV104

Mon, 26 Oct 2026 08:01:17 -0400

Hepion Pharmaceuticals (OTCQB: HEPA) reported results from a modeling and simulation analysis of GV104, an investigational buccal film of the opioid antagonist nalmefene, along with written feedback from the U.S. Food and Drug Administration on the submission.

GV104 is being developed as a prophylactic countermeasure for military personnel and first responders who may be exposed to high-potency opioids, including weaponized fentanyl. The analysis, submitted to the FDA in July 2026 by Hepion's subsidiary Gravitas Life Sciences, combines population pharmacokinetics with a physiological model of opioid overdose.

In simulations of 200 virtual subjects, a single 16 mg GV104 buccal film taken at least

Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest

Mon, 26 Oct 2026 08:01:00 -0400

RED BANK, NJ / ACCESS Newswire / October 26, 2026 / Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) ("Hepion" or the "Company"), a biotechnology company developing therapeutic and diagnostic candidates for areas of high unmet medical need, today reported results from an expanded modeling and simulation analysis of GV104, conducted by its wholly-owned subsidiary Gravitas Life Sciences, LLC ("GLS"), and the written feedback received from the U.S. Food and Drug Administration ("FDA" or "Agency"). The simulation modelled lethal fentanyl doses. In the simulations, a single 16 mg GV104 buccal film taken at least 15 minutes

Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest

Mon, 26 Oct 2026 08:01:00 -0400

Form SCHEDULE 13G/A Hepion Pharmaceuticals, Filed by: RICKEL KENNETH

Wed, 21 Oct 2026 16:57:00 -0400

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Form 3 Hepion Pharmaceuticals, For: Oct 06 Filed by: Gravitas Collective Corp.

Wed, 21 Oct 2026 16:30:00 -0400

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Hepion unit gets FDA feedback on GV104 for gambling disorder

Mon, 19 Oct 2026 08:06:47 -0400

Hepion Pharmaceuticals, Inc. (OTCQB: HEPA) announced that its subsidiary Gravitas Life Sciences, LLC received written responses from the U.S. Food and Drug Administration regarding a pre-Investigational New Drug meeting request for GV104, an investigational transmucosal buccal film of nalmefene, for the treatment of gambling disorder.

The FDA's Division of Psychiatry addressed the regulatory pathway, nonclinical package, Phase 2 study design, and next steps. The agency provided guidance on a 505(b)(2) New Drug Application route, under which Gravitas Life Sciences intends to rely in part on the FDA's prior findings for an approved nalmefene product.

The FDA confirmed that Gravitas Life Sciences may

Hepion Pharmaceuticals Receives Positive FDA Response on GV104 in Gambling Disorder, a Condition With No Approved Medication

Mon, 19 Oct 2026 08:01:00 -0400

RED BANK, NJ / ACCESS Newswire / October 19, 2026 / Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) ("Hepion" or the "Company"), a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases, today announced that its wholly-owned subsidiary Gravitas Life Sciences, LLC ("GLS"), a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation, has received written responses from the U.S. Food and Drug Administration ("FDA"or "Agency") to its Type B pre-Investigational New Drug ("pre-IND") meeting request for GV104, a transmucosal buccal film, in the treatment of

Hepion Pharmaceuticals Receives Positive FDA Response on GV104 in Gambling Disorder, a Condition With No Approved Medication

Mon, 19 Oct 2026 08:01:00 -0400

Form S-8 Hepion Pharmaceuticals,

Wed, 14 Oct 2026 16:16:00 -0400

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Hepion Pharmaceuticals acquires Gravitas Life Sciences, adds two programs

Wed, 14 Oct 2026 08:01:13 -0400

Hepion Pharmaceuticals, Inc. (OTCQB: HEPA) completed its acquisition of Gravitas Life Sciences, LLC on October 6, 2026, making the clinical-stage biotechnology company a wholly-owned subsidiary, according to a press release statement.

The acquisition adds two licensed programs to Hepion's portfolio. GV104 is a transmucosal buccal film of an opioid antagonist in clinical development for temporary prophylaxis of respiratory and central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids. In March 2025, the FDA stated that additional clinical studies did not appear necessary to define the prophylactic dosing window. GV023 is an oral formulation of infliximab,

Hepion Pharmaceuticals Completes Acquisition of Gravitas Life Sciences and Provides Corporate Update

Wed, 14 Oct 2026 08:01:00 -0400

RED BANK, NJ / ACCESS Newswire / October 14, 2026 / Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) ("Hepion" or the "Company"), a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases, today announced that it has completed the acquisition of Gravitas Life Sciences, LLC ("GLS"), a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation. The transaction closed on October 6, 2026, and GLS is now a wholly-owned subsidiary of the Company.

GLS brings two licensed programs: GV104 is a transmucosal buccal film of an approved

Hepion Pharmaceuticals Completes Acquisition of Gravitas Life Sciences and Provides Corporate Update

Wed, 14 Oct 2026 08:01:00 -0400

GLS brings two licensed programs: GV104 is a transmucosal buccal film of an approved

Form 8-K Hepion Pharmaceuticals, For: Oct 06

Fri, 09 Oct 2026 16:31:00 -0400

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Form 4 Hepion Pharmaceuticals, For: Sep 29 Filed by: Fisher Danina

Fri, 02 Oct 2026 16:31:00 -0400

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Form 8-K Hepion Pharmaceuticals, For: Oct 01

Fri, 02 Oct 2026 09:25:00 -0400

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Form 8-K Hepion Pharmaceuticals, For: Sep 21

Mon, 28 Sep 2026 06:30:00 -0400

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Form 3 Hepion Pharmaceuticals, For: Aug 03 Filed by: KI Holdings, Ltd.

Wed, 16 Sep 2026 16:18:00 -0400

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Form SCHEDULE 13D/A Hepion Pharmaceuticals, Filed by: KI Holdings, Ltd.

Wed, 16 Sep 2026 16:15:00 -0400

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Form SCHEDULE 13G Hepion Pharmaceuticals, Filed by: RICKEL KENNETH

Tue, 15 Sep 2026 17:30:00 -0400

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Form 4 Hepion Pharmaceuticals, For: Sep 03 Filed by: LoPriore Vincent S

Mon, 14 Sep 2026 06:30:00 -0400

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Form DEF 14C Hepion Pharmaceuticals, For: Sep 10

Thu, 10 Sep 2026 16:30:00 -0400

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Form 4 Hepion Pharmaceuticals, For: Aug 19 Filed by: Purcell Michael J.

Thu, 10 Sep 2026 16:15:00 -0400

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Form 8-K Hepion Pharmaceuticals, For: Aug 25

Thu, 27 Aug 2026 16:31:00 -0400

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Form 8-K Hepion Pharmaceuticals, For: Aug 25

Thu, 27 Aug 2026 16:31:00 -0400

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