- Adverum Biotechnologies (NASDAQ:ADVM +16%) is up on almost 20% higher volume in response to its announcement that the FDA has lifted the clinical hold on the second cohort in a Phase 1 study, OPTIC, evaluating lead gene therapy ADVM-022 (AAV.7m8-aflibercept) in patients with wet age-related macular degeneration (wet AMD).
- The FDA action allows dose escalation to three times that used in the first cohort, although a lower dose will be administered when treatment resumes next month.
- The partial clinical hold, which suspends enrollment but allows current participants to continue treatment, remains in effect for the third cohort. Citing the promising responses seen in the first cohort, the company does not plan to use the highest dose in this group.
- The FDA instituted the clinical hold last month to allow it to review additional chemistry, manufacturing and controls (CMC) information.
Adverum up 16% on advancement of ADVM-022 in early-stage wet AMD study
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| Symbol | Last Price | % Chg |
|---|---|---|
| ADVM | - | - |
| Adverum Biotechnologies, Inc. | ||