Track Record
Every PDUFA prediction documented against the actual FDA outcome. No cherry-picking. Wins and losses both logged.
| Ticker | Drug / Indication | PDUFA Date | PoA | Grade | STN Risk | FDA Outcome | Actual Move | PoA ✓ |
|---|---|---|---|---|---|---|---|---|
| VNDA | Bysanti · Gastroparesis | 2025-02-21 | 78% | STRONG | MODERATE | ✅ APPROVED | +45% | ✓ |
| FBIO | Lymphir · CTCL | 2025-08-14 | 74% | STRONG | ELEVATED | ✅ APPROVED | +3% | ✓ |
| VNDA | Tradipitant · Gastroparesis (2nd) | 2025-12-27 | 76% | STRONG | MODERATE | ✅ APPROVED | +28% | ✓ |
| AQST | Anaphylm · Anaphylaxis | 2025-11-15 | 68% | WATCH | — | ⏸ DELAYED | — | — |
| LNTH | Flurpiridaz F 18 · Myocardial Perfusion | 2026-03-29 | 77.5% | STRONG | — | ⏸ DELAYED 3mo | — | — |
| DNLI | Denali Therapeutics · Neuroscience | 2026-03-25 | 77.5% | STRONG | LOW | ✅ APPROVED | +8% | ✓ |
| RCKT | Kresladi · LAD-I Gene Therapy | 2026-03-28 | 77.5% | STRONG | HIGH | ✅ APPROVED | -20% | ✓ |
| Ticker | Drug / Indication | PDUFA Date | PoA | Grade | STN Risk | FDA Outcome | Actual Move | PoA ✓ |
|---|---|---|---|---|---|---|---|---|
| TVTX | FILSPARI · FSGS | 2026-04-13 | 72.0% | STRONG | MODERATE | Pending — 16 days | — | — |
How We Track Accuracy
Every PDUFA event scored by Submarine Catalyst is logged before the FDA decision date. After the decision, the actual outcome (Approved, CRL, Delayed, Withdrawn) is recorded against our predicted PoA score and grade.
A prediction is marked correct if: the scanner scored PoA ≥ 65% and the drug was approved, OR the scanner scored PoA < 50% and the drug received a CRL/rejection. Delayed events are not counted as wins or losses.
Sell-The-News (STN) Risk Score — NEW
Approval ≠ stock move. The scanner now includes a Post-Approval Move Score that predicts whether an FDA approval will actually move the stock. This was added after observing that RCKT was approved (PoA correct) but the stock dropped 20% — a textbook sell-the-news event.
The STN Risk score evaluates:
• PoA priced-in factor — Higher PoA = more priced in = less upside on approval
• Application type — sNDA/supplements are incremental, not transformative
• Revenue potential — Small/rare indication vs large market blockbuster
• AdCom unanimity — Unanimous vote = zero surprise value in approval
• Resubmission status — Post-CRL approval was already expected
• Competitive landscape — Crowded market reduces differentiation
• First-in-class / PRV eligible — Unique value drivers that support price
Risk levels: VERY LOW → LOW → MODERATE → ELEVATED → HIGH
The PoA model tells you IF it gets approved. The STN risk tells you if that approval is worth trading.
This page will be updated within 24 hours of every PDUFA resolution. No exceptions. No deletions.
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