Adverum accelerates enrollment timeline for wet AMD gene therapy trial

REDWOOD CITY, Calif. - Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a $79 million market cap biotechnology company whose stock has surged over 22% in the past week, announced Monday it expects to complete enrollment for its pivotal ARTEMIS Phase 3 trial ahead of schedule, with full enrollment anticipated in the fourth quarter of 2025 instead of the previously projected first quarter of 2026.

The company has notified clinical trial sites to complete screening by September 30, just seven months after the trial’s initiation. As a result of the accelerated enrollment, Adverum now expects topline data from the trial to be available in the first quarter of 2027. According to InvestingPro data, the company’s financial health score remains weak, with significant cash burn and negative EBITDA of -$172 million in the last twelve months.

The ARTEMIS trial, the first of two planned Phase 3 registrational trials, is evaluating Ixo-vec (ixoberogene soroparvovec) as a potential one-time treatment for wet age-related macular degeneration. The study will include at least 284 patients, both treatment-naïve and previously treated, comparing a single administration of Ixo-vec to aflibercept given every eight weeks.

Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence. Unlike other ophthalmic gene therapies requiring surgical administration under the retina, Ixo-vec is designed to be administered as a one-time intravitreal injection in a physician’s office.

The treatment has received Fast Track and Regenerative Medicine Advanced Therapy designations from the FDA, PRIME designation from the European Medicines Agency, and the Innovation Passport from the United Kingdom’s regulatory authority.

According to the press release statement, Adverum aims to establish gene therapy as a new standard of care for prevalent ocular diseases, with the goal of developing treatments that could eliminate the need for frequent eye injections. With analyst price targets ranging from $3 to $33, investors seeking deeper insights can access comprehensive analysis and 12 additional ProTips through InvestingPro, which offers detailed financial health metrics and expert research reports for over 1,400 US stocks.

In other recent news, Mizuho has adjusted its price target for Adverum Biotechnologies, lowering it to $12 from the previous target of $16. Despite this reduction, Mizuho continues to maintain an Outperform rating on the company’s shares. The 25% decrease in the price target is attributed to updated financial projections for the first quarter of 2025 and an increase in the weighted average cost of capital assumption to 16% from 15%. This adjustment was partially offset by a decrease in longer-term operating expenses. These developments reflect Mizuho’s analysis of the company’s financial outlook. Investors may find this information relevant when considering their investment strategies.

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