Adverum Biotechnologies, Inc. - ADVM STOCK NEWS

Adverum Biotechnologies (Nasdaq: ADVM) announced the appointment of Star Seyedkazemi, Pharm.D., as its Chief Development Officer. Dr. Seyedkazemi joins the executive committee and will focus on advancing the lead clinical program, ADVM-022, aimed at treating wet age-related macular degeneration (wet AMD). She brings over 16 years of experience in clinical development from companies like Allergan and Pliant Therapeutics. An inducement grant of stock options for 425,000 shares was also provided, vesting over four years. This leadership change aims to strengthen Adverum’s clinical operations.

Adverum Biotechnologies announced that the FDA has granted Orphan Drug Designation to ADVM-062, a gene therapy aimed at treating blue cone monochromacy (BCM). ADVM-062 delivers a functional copy of the OPN1LW gene via intravitreal injection, addressing a significant unmet medical need. BCM affects 1 to 9 in 100,000 males globally and currently has no cure. The designation offers incentives for development and could lead to a seven-year marketing exclusivity if approved. Adverum plans to present preclinical data in 1H2022 and submit an IND application by year-end 2022.

Adverum Biotechnologies (Nasdaq: ADVM) announced plans for a Phase 2 trial of ADVM-022 in wet AMD, expecting to dose the first patient in Q3 2022. The trial will investigate two dosage levels and employs new steroid prophylaxis regimens. The company anticipates its cash reserves will support operations through 2024, as it also plans leadership hiring and board expansions. Key outcomes from previous studies showed a greater than 80% reduction in required anti-VEGF injections, enhancing confidence in ADVM-022's potential. All plans are subject to regulatory reviews.

Adverum Biotechnologies, Inc. (Nasdaq: ADVM) has appointed Rupert D’Souza, Ph.D., M.B.A., as its new Chief Financial Officer (CFO). D’Souza will be a member of the executive committee and will oversee financial operations, planning, and accounting. He aims to leverage his expertise to advance the company’s Phase 2 clinical trial for ADVM-022 targeting wet age-related macular degeneration. The company is well-positioned financially, with a projected cash runway into 2024. D’Souza received a stock option grant of 400,000 shares as part of his inducement offer.

Adverum Biotechnologies (Nasdaq: ADVM) reported its Q3 financial results for the period ending September 30, 2021. The company continues to focus on its gene therapy ADVM-022 for wet age-related macular degeneration (wet AMD). Key highlights include data presentation showing an over 80% reduction in annualized anti-VEGF injections for patients. Financially, total cash and short-term investments were $332.7 million, while R&D expenses rose to $24.1 million. The net loss increased to $38.4 million, or $0.39 per share, compared to $27.8 million, or $0.31 per share, in Q3 2020.

Adverum Biotechnologies (Nasdaq: ADVM) focuses on advancing ADVM-022 for wet age-related macular degeneration (wet AMD) after presenting data from the INFINITY clinical trial at the ASRS meeting. The company is shifting its development strategy from diabetic macular edema (DME) to wet AMD, emphasizing low doses (2 x 10¹¹ vg/eye) with promising safety and durability observed in previous trials. Key findings highlighted the importance of patient characteristics and dosing in achieving therapeutic efficacy and safety.

Adverum Biotechnologies (Nasdaq: ADVM) presented promising long-term results from its OPTIC clinical trial of ADVM-022, a gene therapy for wet AMD. Key findings include a sustained >80% reduction in annualized anti-VEGF injection frequency and over 50% of patients remaining free of injections at a median follow-up of 1.7 years post-treatment. Safety data indicates mild to moderate adverse events with no significant complications. The company plans further analysis and a Phase 2 trial to enhance safety and evaluate lower doses.

Adverum Biotechnologies, Inc. (Nasdaq: ADVM) has announced new clinical data for its gene therapy, ADVM-022, focusing on wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The company plans to present this data at the Retina Society’s Annual Scientific Meeting on October 1 and the ASRS Annual Scientific Meeting on October 9. Adverum is moving forward with the development of ADVM-022 in wet AMD, but has decided to halt its development for DME. Upcoming presentations will detail the Phase 1 OPTIC and Phase 2 INFINITY trial data.

Adverum Biotechnologies (Nasdaq: ADVM) has appointed Jim Wang, Ph.D., as senior vice president, head of regulatory affairs. Dr. Wang brings over 17 years of regulatory experience, notably his success in obtaining global approvals for LUXTURNA^®, the first ocular gene therapy approved in the U.S. and EU. His role includes steering regulatory strategies for Adverum's drug pipeline, particularly ADVM-022 for wet AMD. Additionally, stock options were granted as inducements for Dr. Wang and Karina Nip, vice president, controller, both vesting over four years.