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Adverum (ADVM) Up on FDA Feedback for Gene Therapy Study

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Adverum Biotechnologies, Inc. (ADVM - Free Report) announced that it has received feedback from the FDA on its investigational new drug (IND) application for initiating a phase II study to evaluate its eye disorder gene therapy candidate ADVM-022. ADVM is planning to complete the IND amendment process by mid-2022 and initiate dosing in the planned mid-stage study during the third quarter of 2022.

Adverum’s planned phase II study will evaluate ADVM-022 as a one-time therapy for wet age-related macular degeneration (wet AMD), a chronic eye disorder that causes blurred vision or a blind spot in your visual field.

ADVM had previously requested the FDA for a type C meeting to discuss the IND application to ensure alignment with the regulatory agency before filing for the amendment. Adverum’s plans to initiate dosing in the third quarter suggest that its planned amendments are in alignment with the regulatory authority.

Shares of ADVM gained 3.1% in after-hours trading on Apr 6 following the news. The stock has declined 27.3% so far this year compared with the industry’s decrease of 12%.

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The planned phase II study will evaluate the 2 x 10^11 vg/eye dose of ADVM-022 used in earlier-stage studies. The new mid-stage study will also evaluate a lower dose of ADVM-022 (6 x 10^10 vg/eye). Adverum is also planning to use the new, enhanced prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids along with ADVM-022, in the study.

Management believes that ADVM-022 has the potential to provide a durable and a safe treatment option.

Adverum had initially evaluated a 6 x 10^11 vg/eye dose of ADVM in an earlier study and later added a cohort for 2 x 10^11 vg/eye dose. ADVM already lowered the dose of ADVM-022 once earlier and is again planning to evaluate a lower dose of ADVM-022. The administration of 6 x 10^10 vg/eye and 2 x 10^11 vg/eye doses resulted in mild adverse events in all patients and different types of inflammation. A lower dose is supposed to lead to a reduction in inflammation events in patients. However, any negative impact on efficacy may hurt prospects.

Zacks Rank & Stocks to Consider

Adverum currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Axcella Health (AXLA - Free Report) , Trevi Therapeutics (TRVI - Free Report) and Voyager Therapeutics (VYGR - 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.

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Estimates for Voyager’s 2022 and 2023 loss have narrowed 38.6% and 29%, respectively over the past 60 days. VYGR has rallied 227.7% so far this year.

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