FDA catalysts, PDUFA dates with approval probability, drug pipeline, cash runway and insider activity — updated automatically from SEC, FDA and ClinicalTrials.gov data.
| PDUFA Date | Drug | Indication | Type | PoA |
|---|---|---|---|---|
| 2026-09-30 | — | children and adults with spinal muscular atrophy (SMA) with | BLA | 89% |
PoA = estimated probability of approval from published base rates and live data. See the full PDUFA calendar →
| Date | Drug | Type | Run-up 30d | Decision 1d | After 5d |
|---|---|---|---|---|---|
| 2025-09-22 | — | BLA | -10.4% | +5.6% | +25.7% |
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