Welcome to our dedicated page for Adverum Biotechnologies news (Ticker: ADVM), a resource for investors and traders seeking the latest updates and insights on Adverum Biotechnologies stock.
Overview of Adverum Biotechnologies, Inc. (NASDAQ: ADVM)
Adverum Biotechnologies, Inc. is a U.S.-based clinical-stage gene therapy company at the forefront of developing innovative treatments for serious and rare ocular diseases. Leveraging a proprietary adeno-associated virus (AAV)-based directed evolution platform, Adverum aims to provide durable efficacy through sustained expression of therapeutic proteins. The company focuses on developing gene therapies for conditions such as alpha-1 antitrypsin (A1AT) deficiency, hereditary angioedema (HAE), and wet age-related macular degeneration (wet AMD).
Core Business and Achievements:
Adverum is advancing a robust pipeline of gene therapy product candidates. Its lead candidate, ADVM-022 (also known as Ixo-vec), is an intravitreal (IVT) injection designed to deliver long-term aflibercept levels, significantly reducing the need for frequent anti-VEGF injections in patients with wet AMD. ADVM-022 is currently being evaluated in multiple clinical trials, including the Phase 2 LUNA trial, showing promising results in maintaining vision and reducing treatment burdens.
Recent Developments:
- Leadership Appointments: In 2023, Adverum appointed Dr. C. David Nicholson and Dr. Rabia Gurses Ozden to its Board of Directors, bringing extensive pharmaceutical and clinical development expertise.
- Clinical Trials: The company reported positive preliminary efficacy and safety data from the LUNA Phase 2 trial, demonstrating significant reductions in anti-VEGF injection rates and strong safety profiles.
- Financial Growth: Adverum completed a $127.5 million private placement financing, expected to fund operations into late 2025.
Key Products and Partnerships:
Adverum’s flagship product, ADVM-022, is a gene therapy candidate for wet AMD. The company collaborates with strategic partners to enhance its research and development efforts, generating revenue through licensing, research agreements, and collaborations.
With its innovative gene therapy platform and strategic initiatives, Adverum aims to transform the standard of care for ocular diseases, preserving vision and potentially offering functional cures.
Latest News:
- November 2023: Appointment of C. David Nicholson, Ph.D., to Board of Directors.
- February 2024: Presentation of preliminary LUNA Phase 2 data at the Macula Society meeting.
- March 2024: Completion of $127.5 million private placement financing.
- April 2024: Upcoming presentation of 26-week LUNA interim analysis at the ASRS Annual Scientific Meeting.
Adverum Biotechnologies (Nasdaq: ADVM) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for Ixo-vec, its gene therapy candidate for treating wet AMD. This designation, along with the previously granted PRIME designation, recognizes Ixo-vec's potential to address unmet medical needs in nAMD treatment. The RMAT program, established under the 21st Century Cures Act, aims to expedite development and review of promising therapies for serious conditions.
RMAT designation offers benefits such as intensive FDA guidance on efficient drug development and potential priority review of the biologics license application (BLA). Adverum plans to share updates from regulatory discussions in Q4 2024.
Adverum Biotechnologies (Nasdaq: ADVM) presented positive 26-week interim results from the LUNA Phase 2 trial of Ixo-vec for wet AMD at the 2024 ASRS Annual Meeting. Key findings include:
1. The 6E10 dose with local prophylaxis was selected for Phase 3 trials.
2. 76% of 6E10 patients were injection-free at 26 weeks.
3. 100% of 6E10 difluprednate-alone patients had no or minimal inflammation.
4. 88% of patients preferred Ixo-vec over prior anti-VEGF injections.
5. Efficacy and safety with 6E10 at 26 weeks were similar to or better than OPTIC at 2E11.
The company plans to present 9-month data and pivotal trial design updates in Q4 2024, with Phase 3 trials expected to begin in H1 2025.
Adverum Biotechnologies (Nasdaq: ADVM) has announced plans to host a webcast on July 17, 2024, to review the 26-week interim data from its ongoing LUNA Phase 2 trial. The trial evaluates ixoberogene soroparvovec (Ixo-vec) for treating wet age-related macular degeneration (wet AMD). This data will be presented at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting. Dr. Charles C. Wykoff, a key investigator in the LUNA study, will lead the presentation. The webcast will start at 8:00 a.m. ET, with the ASRS presentation scheduled for 8:45 a.m. CEST. Both the live webcast and a subsequent replay will be accessible on Adverum’s website.
Adverum Biotechnologies (Nasdaq: ADVM), a clinical-stage company focused on gene therapy for ocular diseases, announced its participation in TD Cowen’s Genetic Medicines & RNA Summit.
Laurent Fischer, M.D., the company's president and CEO, will engage in a fireside chat at the summit on June 21, 2024, at 10:00 a.m. ET.
The event will be webcasted live and accessible via Adverum's website under the Investors section, with a replay available for at least 30 days post-event.
Adverum Biotechnologies announced the appointments of Dr. Rabia Gurses Ozden as Chief Medical Officer and Dr. Szilárd Kiss as a Board Member, effective June 11, 2024. Dr. Ozden, with over 20 years in ophthalmology drug development, transitions from the board to the executive team, bringing her expertise in clinical development and gene therapies. Dr. Kiss, an experienced retina specialist and gene therapy expert, will fill Ozden's vacated board seat. Their contributions are expected to advance Adverum's Ixo-vec gene therapy for wet AMD, particularly through the LUNA trial and pivotal studies.
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) reported Q1 2024 financial results and pipeline highlights, showcasing strong cash position, positive preliminary data from the LUNA trial, and upcoming milestones. The company presented a 26-week interim analysis at ASRS on Ixo-vec for wet AMD, with promising reduction in injections and good tolerability. Financially, the company's cash, cash equivalents, and short-term investments increased to $193.3 million, supporting operations into late 2025.
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) will participate in upcoming investor conferences in May 2024 to showcase its gene therapy for ocular diseases. The company will present at the 2024 RBC Global Healthcare Conference, BofA Securities 2024 Health Care Conference, and H.C. Wainwright 2nd Annual BioConnect Investor Conference. Investors can access the webcast on Adverum's website.
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