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Adverum (ADVM) Completes IND Amendment for Gene Therapy Study

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Adverum Biotechnologies, Inc. (ADVM - Free Report) announced that it has completed the investigational new drug (“IND”) amendment with the FDA to begin a mid-stage study on its gene therapy candidate, ADVM-022, for treating wet-age-related macular degeneration (wet AMD).

Following this latest development, the company is planning to initiate the phase II LUNA study to evaluate ADVM-022 for treating wet AMD — a chronic eye disorder that causes blurred vision or a blind spot in your visual field.

The company plans to dose the first patient in the above-mentioned study later in the third quarter of 2022.

The World Health Organization’s Review Council and the United States’ Adopted Names Council have decided on ixoberogene soroparvovec (Ixo-vec) as the international non-proprietary name for ADVM-022.

Shares of Adverum gained 6% on Wednesday following the announcement of the news. The stock has lost 30.1% so far this year compared with the industry’s decrease of 21.1%.

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The phase II LUNA study will evaluate two doses of Ixo-vec — 2 x 10^11 vg/eye and a new lower dose — 6x10^10 vg/eye (6E10) — in patients with wet AMD. The study is designed to determine a safe and effective prophylactic steroid regimen for the given patient population.

Along with the press release, ADVM stated that it has taken measures to restructure its operations, reducing both expenses as well as headcount to prioritize the clinical development of Ixo-vec. The restructuring measures are intended to fully support the development of ADVM-022 and extend the cash runway by approximately one year into 2025.

Adverum had cash, cash equivalents and short-term investments worth $271.1 million as of Mar 31, 2022.

Last month, the European Medicines Agency granted Priority Medicines or PRIME designation to ADVM-022 for the treatment of wet AMD.  ADVM-022 is being developed as a one-time, injection for the treatment of patients with wet AMD.

Zacks Rank & Stocks to Consider

Adverum currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. (LPTX - Free Report) , Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and Precision BioSciences, Inc. (DTIL - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.

Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.

Aeglea BioTherapeutics’ loss per share estimates narrowed 12.7% for 2022 and 25.6% for 2023 in the past 60 days.

Earnings of Aeglea BioTherapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.

Precision BioSciences’ loss per share estimates narrowed 26.2% for 2022 and 42.6% for 2023 in the past 60 days.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.