Organogenesis Confirmed to Start FDA License Application for ReNu
By Katherine Hamilton
Organogenesis received confirmation to initiate a license application with the Food and Drug Administration for its knee condition treatment ReNu.
The regenerative tissue company said Monday it plans to initiate a rolling Biologics License Application for ReNu before the end of December.
Shares gained 9% to $5.28 in after-hours trading.
The plans come after a planned Type-B meeting with the FDA, which was completed Monday, Organogenesis said.
Organogenesis has done two large Phase 3 trials of ReNu, plus a separate randomized controlled trial.
ReNu is designed to treat people with symptomatic knee osteoarthritis, a degenerative condition that causes knee pain. It affects 31.1 million Americans and is ranked among the most common causes of disability and poor quality of life, Organogenesis said.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
December 15, 2025 17:26 ET (22:26 GMT)
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