---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-22-006969"
form_type: "8-K"
ticker: "ANIK"
cik: "0000898437"
company_name: "Anika Therapeutics, Inc."
filed_at: "2022-11-01T23:59:59+00:00"
generated_at: "2026-06-22T20:59:55.229676+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Anika's Cingal succeeds in Phase III 19-01, beats steroid alone at 26 weeks

## Summary
- Cingal met primary endpoint in U.S. Phase III study 19-01: superior to TH steroid at 26 weeks (p=0.0406).
- Across three Phase III studies (n=741), Cingal showed mean 71% pain improvement and 91% responder rate at 26 weeks.
- Anika to meet FDA in coming months to discuss next steps for U.S. regulatory approval of Cingal.
- FDA may require a single full factorial pivotal study before NDA submission, as per prior advice.
- Cingal already commercialized in over 35 countries; Anika exploring U.S. and Asian commercial partnerships.

## SEC filing metadata
- accession: 0001171843-22-006969
- form_type: 8-K
- ticker: ANIK
- cik: 0000898437
- company_name: Anika Therapeutics, Inc.
- filed_at: 2022-11-01T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/898437/000117184322006969/0001171843-22-006969-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/898437/000117184322006969/f8k_110122.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-22-006969
- JSON: https://secwatch.observer/filing/0001171843-22-006969.json
- Plain text: https://secwatch.observer/filing/0001171843-22-006969.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.