Anika posts 10% sales growth, but FDA rebuffs Hyalofast application

Anika Therapeutics grew sales by 10% in the third quarter of 2026 to $30.6 million, but the quarter's good news was tempered by a regulatory rejection for one of its products. In October the US Food and Drug Administration told the company that its premarket approval (PMA) application for Hyalofast, a cartilage product, could not be approved. Anika said the agency's conclusion rested chiefly on the clinical data.

Sales in the company's commercial channel expanded by 17%, outpacing the group as a whole. Anika booked a GAAP loss of $0.3 million from continuing operations. Following the result, it moved up the bottom of its full-year 2026 revenue range and increased its adjusted EBITDA guidance. The material available does not state the new figures.

The information on file does not set out what specific shortcomings the FDA identified in the Hyalofast data, or what Anika plans to do next with the application. The financial impact of the decision on the company has not been quantified.

Elsewhere in its portfolio, Anika signed a new 10-year distribution agreement with Boehringer Ingelheim for Hyvisc this month; financial terms were not provided. The company also said it expects to file a new drug application (NDA) for Cingal before the end of 2027, which implies that a US ruling on that product is still some way off.