Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
FOCL Catalyst Timeline
Dated clinical, regulatory and corporate events for EDAP TMS S.A. American Depositary Shares
Past FDA Catalysts and PDUFA Decisions
How FOCL actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| - | Example Drug | Phase 3 data readout | Phase 3 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|
Clinical Trial Results
Readouts, endpoints and source filings for every FOCL program
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Horn David R.Director | Buy | 10,000 10,000 held | $4.75 | 08/14/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in FOCL
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in FOCL for Q2 2026. | ||||
FOCL Institutional Ownership Trends
FOCL Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How FOCL ranks across every disease it competes in
FOCL News
2026 Investor Day Nasdaq (FOCL) June 1, 2026 1
FocalTherics is gearing up for its 2026 Investor Day, highlighting its strategic transformation into a leader in robotic focal therapy. The company aims to focus on High Intensity Focused Ultrasound (HIFU) technology, especially in treating prostate cancer, while planning to discontinue its Extracorporeal Shock Wave Lithotripsy (ESWL) operations. Management projects strong revenue growth as they expand their market presence and emphasize innovative approaches in therapeutics. However, they acknowledge various risks associated with market acceptance, competition, and the transition away from non-core segments.
Read more →The Global Leader in Therapeutic Ultrasound 1
Focal One is positioned as a global leader in therapeutic ultrasound, particularly in treating prostate cancer. The technology utilizes high-intensity focused ultrasound (HIFU) for optimal cancer control while preserving quality of life. With approximately 1.5 million new prostate cancer cases each year, the technology meets an urgent need in a large and underserved patient population. Positive clinical outcomes demonstrate the efficacy of HIFU compared to traditional surgical options, suggesting a paradigm shift in prostate cancer management.
Read more →EDAP Announces Preliminary Record Fourth Quarter and Full Year 2025 HIFU Revenue; Issues 2026 Revenue Guidance
EDAP TMS SA announced record revenues for the fourth quarter and full year 2025, primarily from its HIFU business. The company reported a 69% increase in Focal One system placements and a 28% growth in procedures in the U.S., highlighting strong global demand. With preliminary revenue guidance for 2026 indicating continued growth, EDAP's CEO emphasized the increasing clinical validation supporting the adoption of their prostate cancer treatments. The company expects significant revenue contributions from its core and non-core businesses in the upcoming year.
Read more →SECURITIES AND EXCHANGE COMMISSION
The report highlights the strong market potential of Focal One's Robotic HIFU therapy for prostate cancer, indicating its ability to address significant unmet clinical needs. With proven clinical evidence and a growing worldwide install base, the technology is positioned to transform prostate cancer treatment paradigms. The report emphasizes increasing patient and physician demand, alongside strong reimbursement support from hospitals. Overall, Focal One's focus on advanced imaging and robotic techniques represents a promising future in urological therapies.
Read more →