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Altimmune, Inc. (Nasdaq: ALT) is a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapeutics and vaccines addressing critical public health and biodefense needs. Leveraging the unique properties of its proprietary platform technologies, Altimmune is adept at swiftly designing product candidates targeting a range of diseases, including respiratory conditions, chronic infections, and cancer.
Altimmune's advanced Densigen™ T-cell platform technology is specifically designed to guide the immune system's response against complex disease targets by focusing on multiple antigens simultaneously. Another key platform, RespirVec™, uses needle-free intranasal delivery for faster and broader immunity against pathogens compared to traditional vaccines.
The company is also heavily involved in addressing obesity and liver diseases through its innovative peptide therapeutics. The lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist under development for obesity and non-alcoholic steatohepatitis (NASH). Pemvidutide has shown promising results in clinical trials, achieving significant weight loss and liver fat reduction. It has received Fast Track designation from the U.S. FDA for treating NASH, highlighting its potential to meet significant unmet medical needs.
Altimmune's pipeline also includes HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. However, the company has recently decided to cease further development on HepTcell based on Phase 2 trial findings.
Financially, Altimmune maintains a robust cash position, enabling it to advance its clinical programs. Recent financial results indicate a focused investment in research and development, ensuring continued progress in its pipeline.
Significant recent achievements include:
- Positive top-line results from the 48-week MOMENTUM Phase 2 obesity trial of pemvidutide.
- Ongoing Phase 2b IMPACT trial of pemvidutide in MASH with top-line results expected in Q1 2025.
- Strong financial position with substantial cash reserves to support ongoing and future research activities.
Altimmune is poised at the forefront of developing transformative therapies for serious health conditions, potentially delivering significant advancements in patient care.
Altimmune, Inc. (Nasdaq: ALT) has initiated enrollment in a Phase 1 clinical trial for AdCOVID, a single-dose intranasal COVID-19 vaccine aimed at generating both systemic and local immunity. The trial targets up to 180 healthy adults aged 18-55 to assess safety and immunogenicity. Results from preclinical studies show promising mucosal immunity responses, crucial for virus transmission prevention. The trial's full data readout is expected by Q2 2021, with the potential for room temperature stability enhancing distribution efficiency.
Altimmune announced the commencement of enrollment in its Phase 1 clinical trial for AdCOVID, a novel intranasal COVID-19 vaccine. The company reported a significant increase in cash reserves to $216 million, up from $37 million year-over-year. Revenue rose to $8.2 million, driven by U.S. government contracts. However, net loss attributed to common stockholders increased to $49 million, reflecting higher R&D and administrative expenses. The company is advancing multiple clinical trials, including ALT-801 and T-COVID, with data readouts expected in 2021.
Altimmune plans to report its full year 2020 financial results on February 25, 2021. The company will hold a conference call at 8:30 AM ET to discuss these results and provide a business update. Altimmune focuses on developing intranasal vaccines and immune modulating therapies, with a diverse pipeline including products for COVID-19, anthrax, influenza, and liver disease. The company's offerings include AdCOVID™, NasoShield™, NasoVAX™, T-COVID™, ALT-801, and HepTcell™.
Altimmune, Inc. (Nasdaq: ALT) has received FDA clearance for its Phase 1 clinical trial of AdCOVID, a single-dose, intranasal COVID-19 vaccine, with patient enrollment set to begin next week. The trial aims to evaluate the safety and immunogenicity of AdCOVID in 180 healthy adults aged 18 to 55. Preclinical studies have shown promising immune responses, and AdCOVID is designed to stimulate both systemic and mucosal immunity. The company anticipates that this vaccine could be stored at room temperature, potentially facilitating broader distribution.
Altimmune has initiated a Phase 2 clinical trial for HepTcell, an innovative immunotherapeutic designed to treat chronic hepatitis B (CHB). Conducted across the U.S., Canada, and Europe, this double-blind study includes 80 adults and will assess safety and efficacy over 24 weeks, with a focus on virological response. CHB affects 292 million globally, with no current cure, leading to significant health risks. HepTcell aims to restore T cell function, addressing a critical unmet need in CHB therapy.
Altimmune, Inc. (Nasdaq: ALT) announced a clinical hold by the FDA on its IND application for AdCOVID, an intranasal COVID-19 vaccine. The FDA has requested protocol modifications and additional CMC data. Altimmune has addressed these requests and does not foresee a significant delay in its clinical development timeline. The company is preparing to initiate a Phase 1 clinical trial for AdCOVID, which has demonstrated promising preclinical results showing robust immune responses against COVID-19.
Altimmune, Inc. (Nasdaq: ALT) announced that Dr. Scott Harris, their Chief Medical Officer, will present on ALT-801, a promising GLP-1/glucagon dual receptor agonist aimed at treating non-alcoholic steatohepatitis (NASH). This presentation is part of the 4th Annual NASH Summit 2020 Digital Conference, taking place from December 15-18, 2020. Dr. Harris will also join a panel discussion on NASH treatments on December 16. ALT-801 shows potential in addressing obesity linked to NASH, with Phase 1 data expected in Q2 2021.
Altimmune, Inc. has initiated dosing in a Phase 1 clinical trial for ALT-801, a dual GLP-1/glucagon receptor agonist targeting non-alcoholic steatohepatitis (NASH), affecting over 13 million adults in the U.S. The trial in Australia will evaluate safety, pharmacokinetics, and activity in 50-60 volunteers. Initial results, including weight loss and liver fat reduction, are expected in Q2 2021, with a follow-up Phase 1b study planned for Q3 2021. The drug aims to improve tolerability and efficacy in treating NASH compared to existing therapies.
Altimmune has submitted an Investigational New Drug (IND) application for its single-dose intranasal COVID-19 vaccine, AdCOVID, to the FDA. AdCOVID aims to stimulate comprehensive immunity, including local nasal mucosal immunity, crucial for preventing virus transmission. The Phase 1 trial is expected to begin in Q4 2020, with data readout anticipated in Q1 2021. The vaccine's advantages include easy administration, room-temperature transport, and potential pediatric use. The FDA has approved the study design and patient population, deeming no additional toxicology studies necessary.
Altimmune, Inc. (Nasdaq: ALT) announced its participation in upcoming virtual investor conferences. These events include the Jefferies London Virtual Healthcare Conference on November 17, 2020, the Piper Sandler 32nd Annual Virtual Healthcare Conference from November 23 to December 3, 2020, and the 3rd Annual Evercore ISI Virtual HealthCONx Conference on December 2, 2020. All sessions will be accessible through the investor relations section of Altimmune's website. The company focuses on developing intranasal vaccines and therapies for diseases, including COVID-19 and liver disease.
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