{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-21-268814","form_type":"8-K","ticker":"APLS","cik":"0001492422","company_name":"Apellis Pharmaceuticals, Inc.","filed_at":"2021-09-09T23:59:59+00:00","discovered_at":"2026-05-14T18:04:18.256610+00:00","generated_at":"2026-06-29T04:47:52.569283+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Apellis announces mixed Phase 3 GA trial results; OAKS met primary endpoint, DERBY missed","bullets":["OAKS trial met primary endpoint: monthly pegcetacoplan reduced GA lesion growth by 22% (p=0.0003), every-other-month by 16% (p=0.0052) vs sham at 12 months.","DERBY trial missed primary endpoint: monthly reduced growth by 12% (p=0.0528), every-other-month by 11% (p=0.0750) vs sham.","Prespecified combined analysis: monthly reduced growth by 17% (p<0.0001), every-other-month by 14% (p=0.0012) vs sham at 12 months.","Greater effect in extrafoveal lesions: combined analysis showed 26% (monthly) and 23% (every-other-month) reduction vs sham (p<0.001).","Company plans to submit NDA to FDA in H1 2022 and MAA in Europe; well-tolerated with low rates of endophthalmitis and intraocular inflammation."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-21-268814","json":"https://secwatch.observer/filing/0001193125-21-268814.json","markdown":"https://secwatch.observer/filing/0001193125-21-268814.md","text":"https://secwatch.observer/filing/0001193125-21-268814.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/0001193125-21-268814-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1492422/000119312521268814/d112979d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T04:47:52.569283+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"}