{"schema_version":"secwatch.filing_event.v1","accession":"0001171843-25-004809","form_type":"8-K","ticker":"ANIK","cik":"0000898437","company_name":"Anika Therapeutics, Inc.","filed_at":"2025-07-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:46.642206+00:00","generated_at":"2026-05-17T23:25:53.570095+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Anika's Hyalofast Phase III misses co-primary endpoints; plans PMA filing by end of 2025","bullets":["Hyalofast missed pre-specified co-primary endpoints (percent change in KOOS Pain and IKDC function vs microfracture) on statistical significance.","Statistically significant improvements on secondary endpoints: KOOS Sports & Recreation, Quality of Life, and Total KOOS.","Safety profile comparable to microfracture; company plans to file final PMA module in H2 2025.","Over 35,000 patients treated outside U.S. since 2009; independent studies support safety and efficacy.","Study impacted by higher dropout in microfracture arm and COVID-related missed visits, reducing evaluable sample size."],"urls":{"canonical":"https://secwatch.observer/filing/0001171843-25-004809","json":"https://secwatch.observer/filing/0001171843-25-004809.json","markdown":"https://secwatch.observer/filing/0001171843-25-004809.md","text":"https://secwatch.observer/filing/0001171843-25-004809.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/898437/000117184325004809/0001171843-25-004809-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/898437/000117184325004809/f8k_072925.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T23:25:53.570095+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"}