Anika Shares Slide 10% as Hyalofast Trial Disappoints, Revenue Drops

Anika Therapeutics reported second-quarter 2025 revenue of $28.2 million, an 8% year-over-year decline, while operating expenses fell 17% as cost-saving measures took hold. Regenerative Solutions sales, led by the Integrity Implant System, jumped 41%, and management reaffirmed full-year revenue and EBITDA guidance. Integrity sales are on track to more than double this year after recent FDA clearance for additional sizes. Separately, the company released topline results from its U.S. Phase III FastTRACK study of Hyalofast, a hyaluronic-acid scaffold for knee cartilage repair. The trial failed to meet its two pre-specified co-primary endpoints for pain and function versus microfracture but delivered statistically significant improvements on several secondary measures, including sports and recreation function and quality of life. Anika intends to submit the final pre-market approval module to the FDA in the second half of 2025 and now assumes a 2027 commercial launch, pushing out its long-term revenue outlook. Investors reacted to the mixed clinical data, sending Anika shares down roughly 10% in pre-market trading.