{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-188117","form_type":"8-K","ticker":"APLS","cik":"0001492422","company_name":"Apellis Pharmaceuticals, Inc.","filed_at":"2023-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:34.071231+00:00","generated_at":"2026-06-13T07:37:17.076881+00:00","sec_items":["7.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Apellis reports 6 retinal vasculitis events after SYFOVRE; rate ~0.01% per injection","bullets":["Six retinal vasculitis events observed after first SYFOVRE injection, 7-13 days post-dose; no specific lot implicated.","Estimated event rate ~1 per 10,000 injections (0.01%); approximately 60,000 vials distributed since FDA approval.","Two events confirmed occlusive, one non-occlusive, three undetermined; etiology unclear, outcomes evolving.","Zero retinal vasculitis events in clinical trials (>23,000 injections); FDA notified, no action planned at this time.","Company investigating with ASRS ReST Committee and external specialists; will update as new info emerges."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-188117","json":"https://secwatch.observer/filing/0001193125-23-188117.json","markdown":"https://secwatch.observer/filing/0001193125-23-188117.md","text":"https://secwatch.observer/filing/0001193125-23-188117.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1492422/000119312523188117/0001193125-23-188117-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1492422/000119312523188117/d510143d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T07:37:17.076881+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}