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Dec 31, 2020
Adverum Q4 2020 Earnings Report
Adverum gained alignment with the FDA on the clinical development path for ADVM-022 and reported financial results.
Key Takeaways
Adverum Biotechnologies announced alignment with the FDA on the clinical development path for ADVM-022 and reported its Q4 2020 financial results. The company is planning to initiate two global Phase 3 trials in Q4 2021 and anticipates a BLA submission in 2024.
Gained alignment with the FDA on the clinical development path for ADVM-022.
Planning to initiate two global Phase 3 trials in Q4 2021.
Anticipates BLA submission in 2024.
Expanding CMC capabilities and investing in an in-house GMP manufacturing facility.
Forward Guidance
Adverum is focused on advancing ADVM-022 and expanding its manufacturing capabilities.
Positive Outlook
- Initiate two global Phase 3 pivotal trials for ADVM-022 in wet AMD in the fourth quarter of 2021
- Present long-term OPTIC data, including one-year data from Cohort 3 (2 x 10^11), in the second quarter of 2021
- Present clinical data from INFINITY Phase 2 trial in the second half of 2021
- Begin build-out of new GMP commercial manufacturing facility in North Carolina with multiple production suites, expected to be production-ready by the end of 2023 in preparation for commercialization of ADVM-022
Historical Earnings Impact
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