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Adverum Biotechnologies, Inc. - ADVM STOCK NEWS

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.
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Adverum Biotechnologies (Nasdaq: ADVM) reported its Q1 2021 financial results on May 6, highlighting a net loss of $28.4 million, or $0.29 per share. License revenue reached $7.5 million, a significant increase from zero in Q1 2020. Research and development expenses rose to $20 million due to heightened clinical trial costs. The company is reviewing safety data linked to its ADVM-022 gene therapy program following a serious adverse event. As of March 31, 2021, cash reserves totaled $404 million, down from $429.7 million at year-end 2020, prompting a reassessment of timelines and funding priorities.

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The Sonic Fund II, L.P., owning about 6.8% of Adverum Biotechnologies (NASDAQ: ADVM), announced ISS's recommendation for stockholders to vote for its nominees – Jean Bennett, Jodi Cook, and Herbert Hughes – in the upcoming 2021 Annual Meeting on May 12, 2021. ISS highlighted Adverum's significant stock underperformance, citing a 54.6% decline compared to peers. Concerns were raised about clinical trial safety and high director compensation. Sonic argues that change is crucial to restore investor confidence and governance independence amid financial challenges.

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Adverum Biotechnologies (Nasdaq: ADVM) announced long-term findings from the OPTIC trial, showing the potential of ADVM-022 gene therapy for wet AMD. After a median follow-up of 88 weeks for the 2 x 1011 vg/eye dose, 60% of patients were injection-free for over a year. Aflibercept protein expression levels were maintained within therapeutic ranges. However, patient safety remains a priority following an unexpected adverse event in the INFINITY study. Ocular adverse events were primarily mild, with a significant reduction in anti-VEGF injection frequency reported.

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The Sonic Fund II, L.P. owns approximately 6.8% of Adverum Biotechnologies (NASDAQ: ADVM) and criticized the Company following its announcement of a Suspected Unexpected Serious Adverse Reaction (SUSAR) in the INFINITY clinical trial for ADVM-022 gene therapy aimed at diabetic macular edema. Sonic claims this reflects a failure in the Company's development approach and loss of shareholder confidence, highlighted by a ~60% stock price drop. They urge immediate changes to the Board, proposing their independent nominees to restore trust and success in ADVM-022's development.

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Adverum Biotechnologies (Nasdaq: ADVM) reported a Serious Adverse Reaction (SUSAR) of hypotony in a patient during its INFINITY clinical trial for ADVM-022, a gene therapy targeting diabetic macular edema. The incident occurred 30 weeks post-treatment with the high dose of ADVM-022. To ensure patient safety, Adverum will unmask the Phase 2 study and review data thoroughly. The INFINITY trial had completed patient dosing by December 2020 and included 36 participants to assess the efficacy of ADVM-022 versus aflibercept.

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The Sonic Fund II, L.P. currently holds approximately 6.8% of Adverum Biotechnologies' outstanding common stock (NASDAQ: ADVM). Sonic has issued a supplemental presentation correcting recent misstatements by Adverum and has nominated three independent candidates—Jean Bennett, Jodi Cook, and Herbert Hughes—for election to the Board of Directors at the 2021 Annual Meeting. The presentation is titled “Adverum’s Myths: Correcting the Record” and is available for review online.

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The Sonic Fund II, owning 6.8% of Adverum Biotechnologies (NASDAQ: ADVM), has nominated three independent candidates for the Board to enhance governance. The investor presentation criticizes Adverum's management of ADVM-022, its wet AMD treatment, citing poor scientific development and miscommunication with investors. Sonic argues that adding independent directors is essential to improve accountability and strategic oversight to restore stockholder confidence. The presentation encourages stockholders to vote for the independent nominees using the GREEN proxy card.

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Adverum Biotechnologies (Nasdaq: ADVM) encourages stockholders to vote for its three independent director nominees at the Annual Meeting on May 12, 2021. The company claims that its gene therapy candidate, ADVM-022, is making significant clinical progress, with a potential Biologics License Application submission in 2024. Adverum has delivered strong stockholder returns, outperforming peers, and is refining its board composition to enhance commercial expertise. The company argues that rival Sonic's nominees would undermine board diversity and operational success.

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Adverum Biotechnologies (Nasdaq: ADVM) is urging stockholders to vote for its three director nominees in the upcoming Annual Meeting on May 12, 2021. The company believes Sonic's nominees lack the necessary qualifications to advance its commercialization of ADVM-022, a gene therapy targeting vision-saving treatments. Adverum emphasizes that its board is well-qualified, having recently appointed seven new independent directors. The company is poised for significant progress, aiming for a Biologics License Application submission in 2024, supporting the vision-saving therapy for wet AMD and DME.

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The Sonic Fund II, L.P. has filed a definitive proxy statement aiming to elect three independent director nominees to the Board of Adverum Biotechnologies (NASDAQ: ADVM) during the 2021 Annual Meeting, scheduled for May 12, 2021. Sonic, owning approximately 6.8% of ADVM's common stock, expresses concerns over Adverum's lack of governance and operational progress, which they believe has diminished stockholder value. They propose nominees with significant expertise in gene therapy and financial leadership, criticizing the current Board for failing to consider these candidates and for using questionable tactics that may disenfranchise stockholders.

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FAQ

What is the current stock price of Adverum Biotechnologies (ADVM)?

The current stock price of Adverum Biotechnologies (ADVM) is $5.75 as of November 21, 2024.

What is the market cap of Adverum Biotechnologies (ADVM)?

The market cap of Adverum Biotechnologies (ADVM) is approximately 127.1M.

What is Adverum Biotechnologies' main focus?

Adverum Biotechnologies focuses on developing gene therapies for serious and rare ocular diseases, including wet age-related macular degeneration (wet AMD).

What is ADVM-022?

ADVM-022, also known as Ixo-vec, is Adverum's lead gene therapy candidate designed to deliver long-term aflibercept levels to treat wet AMD, reducing the need for frequent anti-VEGF injections.

What recent leadership changes have occurred at Adverum?

In 2023 and 2024, Adverum appointed Dr. C. David Nicholson and Dr. Rabia Gurses Ozden to its Board of Directors, enhancing its pharmaceutical and clinical expertise.

How is Adverum Biotechnologies funded?

Adverum generates revenue through licensing, research agreements, and collaborations. The company also recently completed a $127.5 million private placement financing.

What are the recent achievements of ADVM-022 in clinical trials?

ADVM-022 has shown promising results in the Phase 2 LUNA trial, with significant reductions in anti-VEGF injection rates and a strong safety profile.

When is Adverum's next major presentation?

Adverum will present the 26-week interim analysis from its LUNA Phase 2 study at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting in July 2024.

What is the significance of Adverum's proprietary AAV-based platform?

Adverum's AAV-based directed evolution platform enables the development of gene therapies that provide durable efficacy through sustained expression of therapeutic proteins, potentially offering long-term solutions for patients.

How does ADVM-022 benefit patients with wet AMD?

ADVM-022 aims to provide long-term aflibercept levels, significantly reducing the treatment burden and fluctuations in macular fluid associated with frequent anti-VEGF injections.

What are the financial projections for Adverum Biotechnologies?

Following its recent financing, Adverum's cash runway is expected to extend into late 2025, supporting ongoing and future clinical trials.

What are the main goals of Adverum Biotechnologies?

Adverum aims to transform the standard of care for ocular diseases, preserve vision, and create a profound societal impact with its innovative gene therapy solutions.

Adverum Biotechnologies, Inc.

Nasdaq:ADVM

ADVM Rankings

ADVM Stock Data

127.10M
15.44M
11.67%
79.15%
7.71%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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