Adverum Biotechnologies (ADVM -7.2%) is down on below-average volume in reaction to its announcement that the FDA has placed a clinical hold on its Phase 1 study, OPTIC, evaluating gene therapy candidate ADVM-022 in patients with wet age-related macular degeneration (wet AMD) citing the need for additional information related to chemistry, manufacturing and controls (CMC), including certain requirements on the manufacturing process.

The company submitted its response last week and expects to resume dosing as soon as allowed, adding that the first cohort of six patients have already been dosed and enrollment is ready to proceed in the second cohort.

Source link

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published. Required fields are marked *