other material
confidence high
sentiment positive
materiality 0.75
Anika's Cingal succeeds in Phase III 19-01, beats steroid alone at 26 weeks
Anika Therapeutics, Inc.
- 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.