Item 8.01 Other Events

The Company is providing the following business updates:

•The Company has submitted to the U.S. Food and Drug Administration ("FDA") the second part of its New Drug Application ("NDA") for avacincaptad pegol ("ACP") for the treatment of geographic atrophy ("GA") secondary to age-related macular degeneration ("AMD"). Consistent with the Company's agreement with the FDA for rolling NDA review, the Company previously submitted the first part of its NDA on November 3, 2022, which included the full ACP clinical data package from the GATHER1 and GATHER2 clinical trials. The recently submitted second part of the NDA included nonclinical data. The remaining, final part of the NDA will include chemistry, manufacturing and controls data. The Company remains on track to complete the submission of its NDA to the FDA by the end of 2022.

•Based on formal feedback received from the FDA, the Company intends to pursue further discussions with the FDA about utilizing the GATHER1 and GATHER2 clinical trial data included in the current NDA submission to support treatment of GA associated with earlier stage disease, including in patients with intermediate AMD ("iAMD"). As a result of these ongoing discussions, the Company does not believe it needs to conduct a new clinical trial of ACP in patients with iAMD.




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