Altimmune Inc
NASDAQ:ALT
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Altimmune Inc
NASDAQ:ALT
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Altimmune Inc
Altimmune, Inc. is a clinical stage biopharmaceutical company, which focuses on peptide-based therapeutics for obesity and liver diseases. The company is headquartered in Gaithersburg, Maryland and currently employs 47 full-time employees. The company went IPO on 2005-10-06. The Company’s lead product candidate, pemvidutide (proposed INN, formerly known as ALT-801), is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and non-alcoholic steatohepatitis (NASH). The company is also developing HepTcell, an immunotherapeutic agent designed to achieve a functional cure for chronic hepatitis B. The firm has initiated a Phase II clinical trial of HepTcell and are in Phase II and Phase I clinical development with pemvidutide for multiple indications. The company is conducting its Phase II clinical trial of HepTcell in the United States, United Kingdom, Canada, Germany and Spain, and conducting Its pemvidutide Phase I clinical trial in Australia. Its wholly owned subsidiaries include Altimmune, LLC, Altimmune UK, Limited, Spitfire Pharma, LLC and Altimmune AU Pty, Limited.
Altimmune, Inc. is a clinical stage biopharmaceutical company, which focuses on peptide-based therapeutics for obesity and liver diseases. The company is headquartered in Gaithersburg, Maryland and currently employs 47 full-time employees. The company went IPO on 2005-10-06. The Company’s lead product candidate, pemvidutide (proposed INN, formerly known as ALT-801), is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and non-alcoholic steatohepatitis (NASH). The company is also developing HepTcell, an immunotherapeutic agent designed to achieve a functional cure for chronic hepatitis B. The firm has initiated a Phase II clinical trial of HepTcell and are in Phase II and Phase I clinical development with pemvidutide for multiple indications. The company is conducting its Phase II clinical trial of HepTcell in the United States, United Kingdom, Canada, Germany and Spain, and conducting Its pemvidutide Phase I clinical trial in Australia. Its wholly owned subsidiaries include Altimmune, LLC, Altimmune UK, Limited, Spitfire Pharma, LLC and Altimmune AU Pty, Limited.
Leadership: New CEO Jerry Durso (joined January) signaled a refocus on pemvidutide and strengthened the team for late‑stage development.
Phase III plan: FDA aligned on a pivotal global Phase III for biopsy‑confirmed F2/F3 MASH: 990 patients in the histology cohort (330 per arm) plus a ~800‑patient NIT cohort — ~1,800 total; primary endpoints at 52 weeks are MASH resolution and fibrosis improvement.
Dose strategy: Phase III will start patients at 1.2 mg with a simple 1‑ or 2‑step monthly titration to either 1.8 mg (primary focus) or 2.4 mg (exploratory for added efficacy/weight loss).
Clinical signal: Phase II (IMPACT) 48‑week data showed antifibrotic activity and 7.5% weight loss at 48 weeks on the 1.8 mg dose; tolerability was favorable with low discontinuations despite no titration in Phase II.
Other programs: AUD Phase II (RECLAIM) completed enrollment; topline expected in Q3 2026. ALD Phase II (RESTORE) continues and is expected to finish enrollment in 2026.
Regulatory: Pemvidutide received FDA Breakthrough Therapy designation. End‑of‑Phase II minutes confirm alignment with FDA on the Phase III design; EMA/MHRA scientific advice submissions are in progress.
Finances: Pro forma cash approximately $340 million (end‑2025 cash $274 million plus January financing), management says runway into 2028 and expects cash burn to increase as Phase III is initiated.
