FDA Agrees on Belapectin Phase 3 Endpoint, Protocol Filing Set for Q3 2026
GALT sits 50% above its 52-week low of $1.85.
Summary
The FDA has agreed on the primary endpoint and regulatory pathway for Galectin's Phase 3 trial of belapectin, with the protocol filing expected in Q3 2026. The agreed-upon endpoint is a composite liver outcome, and the FDA confirmed a traditional full approval pathway, indicating a single well-controlled trial could support marketing approval. This significantly de-risks the development of the company's lead asset, which is critical for a small-cap biotech. This positive update follows an 8-K filed minutes prior and positive data presented at EASL in May. Investors will be watching for the Q3 2026 protocol filing and any announcements regarding strategic or financial partnerships.
At the time of this announcement, GALT was trading at $2.77 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $184.4M. The 52-week trading range was $1.85 to $7.13. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Wiseek News.