Fractyl Health's Q3 net loss narrows as costs fall, shifts focus to Revita

Overview

• US metabolic therapeutics firm's Q3 net loss narrowed from prior year on lower operating expenses

• Company announced plans to cut workforce by 45% and discontinue internal Rejuva development to focus on Revita in October

• Positive six-month pivotal trial results for Revita; FDA De Novo submission planned for late Q4 2026

Outlook

• Fractyl plans FDA De Novo submission for Revita in late Q4 2026

• Company expects topline 12-month REMAIN-1 Pivotal Cohort data in Q1 2027

• Fractyl expects quarterly operating cash spending to fall to about $8 mln by end-Q2 2027

Result Drivers

• POSITIVE TRIAL RESULTS - REMAIN-1 met its six-month co-primary endpoint for weight loss retention after GLP-1 discontinuation with high statistical significance

• CASH POSITION - As of September 30, Fractyl had approximately $31.5 million in cash and cash equivalents

• CAPITAL - Co expects capital to be sufficient to fund planned De Novo submission and upcoming 12-month pivotal data

Company press release:

Key Details

Analyst Coverage

• The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 6 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

• The average consensus recommendation for the biotechnology & medical research peer group is "buy"

• Wall Street's median 12-month price target for Fractyl Health, Inc. is $39.00, about 4,325.8% above its November 11 closing price of $0.88

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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)