Altimmune (ALT) Company Report

Altimmune, Inc. announced the closing of a registered direct offering, resulting in approximately $75 million in gross proceeds.
The offering involved the sale of 17,045,454 shares of common stock (or pre-funded warrants) to a new fundamental institutional investor.
The net proceeds are intended to fund the company's upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH), as well as for working capital and general corporate purposes.

1 day ago

Press Release

Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide

ALT

New Projects/Investments

Altimmune (NASDAQ: ALT) received FDA Breakthrough Therapy Designation for pemvidutide for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH).
This designation aims to expedite the development and review of medicines for serious conditions showing preliminary clinical evidence of substantial improvement over existing therapies.
The company also completed a productive end-of-phase 2 meeting with the FDA, establishing alignment on parameters for a registrational Phase 3 trial of pemvidutide in MASH patients with moderate to advanced liver fibrosis.
Altimmune plans to initiate a Phase 3 trial to evaluate multiple pemvidutide doses over a 52-week treatment period, incorporating biopsy-based endpoints to support potential accelerated approval.

1 day ago

Press Release

Altimmune, Inc. announces $75 million registered direct offering

ALT

Altimmune, Inc. entered into a Securities Purchase Agreement on January 27, 2026, with a new fundamental institutional investor for a registered direct offering.
The offering includes 12,397,920 shares of common stock and pre-funded warrants to purchase up to 4,647,534 shares of common stock.
The company expects to receive approximately $75 million in gross proceeds from this offering, which is anticipated to close around January 29, 2026.
Titan Partners Group LLC is serving as the sole placement agent for the offering.
Directors and executive officers have agreed to 30-day lock-up agreements following the closing of the offering.

2 days ago

8-K

Altimmune Announces $75 Million Registered Direct Offering

ALT

New Projects/Investments

Altimmune, Inc. has entered into a securities purchase agreement for a registered direct offering of 17,045,454 shares of common stock (or pre-funded warrants).
The offering is expected to result in approximately $75 million in gross proceeds.
The net proceeds are intended to fund preparation for its upcoming Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH), as well as for working capital and general corporate purposes.
The offering is anticipated to close on or about January 29, 2026.

3 days ago

Press Release

Altimmune's Pemvidutide Receives FDA Breakthrough Therapy Designation

ALT

New Projects/Investments

Altimmune's pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The BTD was granted based on 24-week data from the IMPACT Phase 2b trial, which demonstrated statistically significant MASH resolution without worsening of fibrosis, along with early and substantial improvements in liver fat and non-invasive tests.
48-week topline IMPACT data, reported in December 2025, showed continued statistically significant improvements in key non-invasive tests and further weight loss at the 1.8 mg dose.
Altimmune has aligned with the FDA on parameters for a registrational Phase 3 trial for pemvidutide in MASH patients with moderate to advanced liver fibrosis, which the company plans to initiate.

Jan 5, 2026, 12:30 PM

Press Release

Altimmune Reports Positive 48-Week Phase 2b Pemvidutide Data for MASH

ALT

New Projects/Investments

Altimmune announced positive 48-week topline data from its IMPACT Phase 2b trial for pemvidutide in patients with MASH, demonstrating further improvements in non-invasive tests of fibrosis and a clear dose response with the 1.8 mg dose.
The 1.8 mg dose of pemvidutide achieved significant and continuing 7.5% weight loss at 48 weeks, with no evidence of plateauing.
The trial maintained a favorable tolerability profile and a low discontinuation rate at 48 weeks.
Altimmune has aligned with the FDA on the pathway to move forward to a registrational Phase 3 trial for MASH, with initiation expected in 2026, and plans to evaluate multiple doses including 2.4 mg.

Dec 19, 2025, 1:00 PM

Presentation

Altimmune Reports Positive Pembidutide Phase 2b MASH Data and Outlines Phase 3 Plans

ALT

CEO Change

New Projects/Investments

Altimmune announced positive top-line 48-week data from its IMPACT Phase 2b trial of Pembidutide in MASH, demonstrating marked improvements in key non-invasive markers of fibrosis and additional weight loss with the 1.8-milligram dose.
The data showed strong anti-fibrotic effects, with ELF improvement greater than 0.5 at the 1.2 mg dose and close to 0.6 for the 1.8 mg dose, and approximately a 30% reduction in liver stiffness.
Following a productive end-of-phase 2 meeting, the company aligned with the FDA on a biopsy-based endpoint for the Phase 3 program, with the FDA open to incorporating the AIM-MASH AI pathology tool and evaluating a 2.4-milligram dose.
Altimmune expects to initiate the Phase 3 MASH trial in 2026, with a sample size anticipated to be on the lower end of 1,000 to 1,500 patients.
Greg Dorso will assume the role of President and CEO at the beginning of next year, succeeding Dr. Vipin Garg.

Dec 19, 2025, 1:00 PM

Transcript

Altimmune Reports Positive 48-Week Pemvidutide MASH Data and Aligns with FDA on Phase 3 Design

ALT

Product Launch

CEO Change

New Projects/Investments

Altimmune reported positive top-line 48-week data from the IMPACT phase 2b trial of Pemvidutide in MASH, demonstrating marked improvements in key non-invasive markers of fibrosis and continued weight loss with the 1.8-milligram dose.
The company achieved alignment with the FDA on the phase 3 program design for MASH, which will include biopsy-based endpoints and the evaluation of multiple Pemvidutide doses, including a 2.4-milligram dose, with the FDA open to incorporating the AIM-MASH AI pathology tool.
Altimmune expects to initiate the phase 3 MASH trial in 2026.
Jerry Durso will assume the role of President and CEO at the beginning of next year, succeeding Vipin Garg.

Dec 19, 2025, 1:00 PM

Transcript

Altimmune Announces Positive 48-Week Phase 2b MASH Trial Data and FDA Alignment for Phase 3

ALT

New Projects/Investments

Management Change

Altimmune announced positive top-line 48-week data from the IMPACT phase 2b trial of Pembidutide in MASH, demonstrating marked improvements in key non-invasive markers of fibrosis and additional weight loss with the 1.8-milligram dose, alongside a favorable tolerability profile with a discontinuation rate due to adverse events lower than placebo.
The company achieved alignment with the FDA on the phase 3 registration program for MASH, which will utilize biopsy-based endpoints, and the FDA is open to incorporating the AIM-MASH AI pathology tool and evaluating a 2.4-milligram dose.
Altimmune anticipates initiating the phase 3 MASH trial in 2026.
Greg Dorso will assume the role of President and CEO at the beginning of next year, succeeding Vipin Garg.

Dec 19, 2025, 1:00 PM

Transcript

Altimmune Announces Positive 48-Week Results from IMPACT Phase 2b MASH Trial

ALT

New Projects/Investments

Altimmune announced positive topline 48-week results from the IMPACT Phase 2b trial of pemvidutide in patients with MASH, demonstrating statistically significant improvements in key non-invasive tests (NITs) for fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), across treatment arms versus placebo.
The trial maintained a favorable tolerability profile at 48 weeks, with a low treatment-related discontinuation rate, and the 1.8 mg dose achieved 7.5% weight loss at 48 weeks, without plateauing.
An End-of-Phase 2 meeting with the FDA supports advancing pemvidutide to a registrational Phase 3 trial for MASH patients with moderate to advanced liver fibrosis, which Altimmune intends to initiate in 2026.
Following September 30, 2025, and through December 19, 2025, the company sold 13,547,341 shares of common stock for net proceeds of approximately $54.6 million through at-the-market offerings.