Fractyl Cuts 45% of Staff, Drops Rejuva to Fund Revita FDA Filing
GUTS is trading near its 52-week low of $1.11 (6.3% above the low) on elevated volume (2.4× avg).
Summary
Fractyl is cutting about 45% of its workforce and discontinuing Rejuva development to concentrate resources on Revita, which met its six-month co-primary endpoint in the 308-patient REMAIN-1 study reported October 16. The company targets an FDA De Novo submission in late Q4 2026, with 12-month pivotal data due in Q1 2027. Cash runway now extends into Q2 2027, and quarterly burn is expected to fall to roughly $8 million by then, about half current levels. This follows the October 2 1-for-12 reverse split and the September Nasdaq delisting notice — the company is buying time and narrowing its story to a single regulatory bet. The De Novo filing is the next hard milestone; approval would be the first U.S. marketing authorization for Revita.
At the time of this announcement, GUTS was trading at $1.18 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $15.3M. The 52-week trading range was $1.11 to $29.34. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Wiseek News.