Monitor the early Q4 2026 REMAIN-1 Pivotal Cohort topline data as the next major catalyst. September Investor Day commercial strategy details could provide near-term upside.
Price Chart
Executive Summary
Fractyl Health reported a Q2 2026 net loss of $25.5M vs $27.9M a year ago, with EPS of -$0.16 beating consensus by 14%. The stock catalyst is the company's clinical data showing Revita patients maintained 84% of prior GLP-1 weight loss vs 46% with sham, with topline pivotal data on track for early Q4 2026 and a potential FDA De Novo submission.
Key Financial Metrics
Key Facts
- Net loss for Q2 2026 was $25.5 million, improved from $27.9 million in Q2 2025
- EPS of -$0.16 beat consensus of -$0.14 by 14.3%
- R&D expenses fell to $13.8 million from $21.2 million year-over-year
- Cash and cash equivalents $47.1M as of June 30, 2026, providing runway into early 2027
- One-year REMAIN-1 Midpoint data showed Revita patients maintained ~84% of prior GLP-1 weight loss vs 46% with sham in optimized population
- Topline 6-month data from REMAIN-1 Pivotal Cohort expected early Q4 2026
- Potential FDA De Novo marketing application submission for Revita late Q4 2026
- First-in-human dosing of RJVA-001 gene therapy candidate expected H2 2026
Financial Impact
Quarterly net loss of $25.5 million, cash burn rate ~$23.6 million/quarter (from cash decrease of $81.5M to $47.1M over 6 months, net of $7M from warrant liability changes)
Risk Factors
- Clinical-stage biotech with no approved products or revenue
- Cash runway only into early 2027, requiring future capital raises
- FDA De Novo pathway is non-binding and submission acceptance is uncertain
- High share count dilution (158.6M shares vs 49.0M YoY) from warrant exercises/equity raises
- ROMA-1 pivotal data may fail to replicate midpoint cohort results
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3342215 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 4d ago | 8-K | $1.13 | awaiting T+5 | — | $1.08 (−4.42%) |
Oct 16, 2026 10d ago | 8-K | $1.55 $1.08 | ▼ −30.32% | ▼ −30.42% | $1.08 (−30.32%) |
Oct 13, 2026 12d ago | SC 13G | $4.03 $1.33 | ▼ −66.96% | ▼ −65.80% | $1.08 (−73.17%) |
Aug 10, 2026 10w ago | 8-K | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Aug 10, 2026 10w ago | Press Release | $0.7018 $0.7171 | ▲ +2.18% | ▲ +2.58% | $1.08 (+53.89%) |
Jul 15, 2026 14w ago | 8-K | $0.9100 $0.7580 | ▼ −16.70% | ▼ −15.72% | $1.08 (+18.68%) |
Jun 12, 2026 19w ago | Institutional Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Insider Cluster | $0.8500 $0.8583 | ▲ +0.98% | ▲ +0.30% | $1.08 (+27.06%) |
Jun 11, 2026 19w ago | Institutional Cluster | $0.7239 $0.8500 | ▲ +17.42% | ▲ +16.99% | $1.08 (+49.19%) |
Jun 4, 2026 20w ago | 8-K | $0.7340 $0.7240 | ▼ −1.36% | ▲ +1.19% | $1.08 (+47.14%) |
US Market Status
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