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 announced promising results from its ADVM-022 program for treating wet AMD. Data show that the human equivalent dose of 6E10 vg/eye achieved therapeutic levels of aflibercept in non-human primates (NHPs), supporting plans for a Phase 2 trial in Q3 2022 with doses of 2E11 vg/eye and 6E10 vg/eye. The OPTIC trial indicated an 81% to 94% reduction in annual anti-VEGF injections, depending on neutralizing antibody levels, with no adverse clinical signs noted. These findings pave the way for potential long-term efficacy against wet AMD.
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) reported its Q1 2022 financial results, indicating a net loss of $37.9 million, equating to $0.38 per share. Cash reserves amounted to $271.1 million, expected to last into 2024. The company is on track to initiate a Phase 2 trial for ADVM-022 in wet AMD, with dosing of the first patient planned for Q3 2022. Positive FDA feedback was received regarding the trial, and ADVM-062 received Orphan Drug Designation for blue cone monochromacy.
Adverum Biotechnologies, Inc. (Nasdaq: ADVM) has granted 130,000 stock options to a new employee as an inducement for joining the company. This grant was made on May 9, 2022, in accordance with Nasdaq Rule 5635(c)(4). The options have an exercise price equal to the stock's closing price on the grant date and will vest over four years, contingent on the employee's continued service. Adverum focuses on gene therapies for ocular and rare diseases, including its candidate ADVM-022 for wet age-related macular degeneration.
Adverum Biotechnologies (Nasdaq: ADVM) announced the presentation of new data at the ASGCT 2022 Annual Meeting from May 16-19, 2022. Key highlights include findings from the OPTIC study evaluating the impact of neutralizing antibodies on ADVM-022's efficacy in treating wet age-related macular degeneration (AMD). Adverum plans to initiate a Phase 2 trial in Q3 2022, testing a higher and a lower dose of ADVM-022. Additionally, the company will present data on ADVM-062, aimed at blue cone monochromacy, which received Orphan Drug Designation from the FDA in January 2022.
Adverum Biotechnologies (Nasdaq: ADVM) presented new findings from the OPTIC study of ADVM-022 for wet age-related macular degeneration (AMD) at the ARVO 2022 meeting. The analysis demonstrated an 81% reduction in mean annualized anti-VEGF injections for all patients and up to 94% for those with baseline neutralizing antibodies (NAbs) <1:125. No safety concerns were linked to NAbs levels. Moving forward, Adverum plans to initiate a Phase 2 clinical trial with the first patient expected to be dosed in Q3 2022.
Adverum Biotechnologies announced that Szilárd Kiss, M.D. will present new analyses from the Phase 1 OPTIC Trial of ADVM-022 in wET AMD at the ARVO 2022 Annual Meeting on May 1, 2022. The trial showed over 80% reduction in annual anti-VEGF injections with the 2E11 dose. New data indicate a correlation between neutralizing antibodies (NAbs) and treatment efficacy. ADVM-022 was well tolerated, with no need for steroids post-treatment. Additionally, on April 18, 2022, Adverum granted stock options to an employee as part of an inducement grant.
Adverum Biotechnologies (Nasdaq: ADVM) has announced plans to complete the Investigational New Drug (IND) amendment process by mid-2022, allowing them to initiate the Phase 2 trial of ADVM-022 for wet age-related macular degeneration (wet AMD) in the third quarter of 2022. Following feedback from the FDA, the trial will evaluate two dosage levels of ADVM-022, aiming for a single intravitreal injection as a durable treatment option. The planned trial responds to the urgent need for long-lasting treatments for wet AMD patients.
Adverum Biotechnologies (Nasdaq: ADVM) reported its Q4 and full-year 2021 financial results, highlighting a net loss of $34.4 million, or $0.35 per share, compared to $37.6 million, or $0.39 per share in Q4 2020. The company plans to initiate a Phase 2 trial for ADVM-022 in wet age-related macular degeneration (AMD) in Q3 2022, bolstered by positive Phase 1 OPTIC trial results showing over 80% reduction in anti-VEGF injections. Cash reserves were $305.2 million at year-end, sufficient to fund operations into 2024.
Adverum Biotechnologies (Nasdaq: ADVM) has appointed Dr. Rabia Gurses Ozden and Ms. Soo J. Hong as independent members of its Board of Directors. Dr. Ozden brings 20 years of experience in ophthalmology and gene therapy, while Ms. Hong specializes in human capital management and executive development. Their expertise is expected to support the advancement of ADVM-022, a gene therapy candidate for treating wet age-related macular degeneration, toward a Phase 2 trial. The company aims to enhance its clinical development and talent retention strategies.
Adverum Biotechnologies (Nasdaq: ADVM) announced that its CEO, Laurent Fischer, M.D., will participate in a panel discussion at the 42nd Annual Cowen Healthcare Conference on March 7, 2022, at 2:10 p.m. ET. The discussion will focus on auditory and ophthalmology topics, highlighting Adverum's commitment to addressing unmet medical needs in ocular and rare diseases. The event will be accessible via a live webcast, with a replay available for 30 days post-event. The conference runs from March 7-9, 2022, showcasing various healthcare industry insights.
FAQ
What is the current stock price of Adverum Biotechnologies (ADVM)?
What is the market cap of Adverum Biotechnologies (ADVM)?
What is Adverum Biotechnologies' main focus?
What is ADVM-022?
What recent leadership changes have occurred at Adverum?
How is Adverum Biotechnologies funded?
What are the recent achievements of ADVM-022 in clinical trials?
When is Adverum's next major presentation?
What is the significance of Adverum's proprietary AAV-based platform?
How does ADVM-022 benefit patients with wet AMD?
What are the financial projections for Adverum Biotechnologies?