Anika Therapeutics, Inc. ANIK
Anika Therapeutics, Inc. (Nasdaq: ANIK) is a pain/anesthesia drug developer. Its lead program, Cingal, is in Phase 3 for Osteoarthritis pain management. Its next catalyst on record is Cingal: NDA submission to FDA (December 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Cingal — NDA submission to FDA (December 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Monovisc | Osteoarthritis pain management | biologic-other | Approved |
| Orthovisc | Osteoarthritis pain management | biologic-other | Approved |
| Integrity Implant System | Rotator cuff repair and other tendon procedures | biologic-other | Approved |
| Tactoset | Bone void filler | biologic-other | Approved |
| Hyvisc | Equine osteoarthritis (veterinary) | biologic-other | Approved |
| Hyalobarrier | Anti-adhesion barrier (abdominal-pelvic surgery) | biologic-other | Approved |
| Hyalomatrix | Complex wound treatment | biologic-other | Approved |
| Anikavisc | Ophthalmic viscoelastic (cataract surgery) | biologic-other | Approved |
| Nuvisc | Ophthalmic viscoelastic (intraocular lens implantation) | biologic-other | Approved |
| Cingal | Osteoarthritis pain management | biologic-other | Phase 3 |
| Hyalofast | Cartilage repair | biologic-other | Phase 3 |
Recent results and decisions
- CRL FDA formally notified Anika that the Hyalofast PMA application is not approvable, primarily based on clinical data.
In October, the Company received formal notification from the FDA that the Hyalofast® pre-market approval (PMA) application is not approvable, primarily based on the clinical data included in the submission.
Filing - completed enrollment Cingal bioequivalence study completed enrollment in September 2026.
In September, enrollment in the Cingal bioequivalence study was completed.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 pain/anesthesia companies
- Mesoblast Ltd MESO
- Latigo Therapeutics, Inc. LTGO
- Scilex Holding Co SCLX
- Ensysce Biosciences, Inc. ENSC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.