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 |
|---|---|---|---|---|
| 2027-05-01 | — | agitation associated with dementia due to Alzheimer’ | NDA | 79% |
PoA = estimated probability of approval from published base rates and live data. See the full PDUFA calendar →
| Drug | Indication | Phase | Status |
|---|---|---|---|
| Solriamfetol Oral Tablet | Excessive Sleepiness | PHASE4 | TERMINATED |
| AXS-05 | Major Depressive Disorder | PHASE4 | RECRUITING |
| Solriamfetol 75 MG | Insomnia | PHASE4 | COMPLETED |
| Solriamfetol | Excessive Daytime Sleepiness | PHASE4 | COMPLETED |
| Bupropion | Major Depressive Disorder | PHASE4 | RECRUITING |
| AXS-02 (oral zoledronate) | Complex Regional Pain Syndrome | PHASE3 | UNKNOWN |
| Solriamfetol Dose B | ADHD | PHASE3 | RECRUITING |
| Solriamfetol Dose A | ADHD | PHASE3 | RECRUITING |
| Solriamfetol 75mg, 150 mg, or 300 mg | Binge-Eating Disorder | PHASE3 | ENROLLING_BY_INVITATION |
| Solriamfetol 300 mg | Excessive Sleepiness | PHASE3 | RECRUITING |
AXSM holds $319.9M in cash and burns about $26.8M/quarter from operations, giving an estimated runway of 35.8 months. A recent offering filing was detected — dilution watch.
Source: SEC EDGAR XBRL (operating cash flow). Get dilution alerts for AXSM free →
| Date | Insider | Type | Value |
|---|---|---|---|
| 2026-08-07 | TABUTEAU HERRIOT |
Purchase | $258,553 |
| 2026-08-07 | TABUTEAU HERRIOT |
Sale | $0 |
| 2026-08-07 | TABUTEAU HERRIOT |
Purchase | $58,851 |
| 2026-08-07 | TABUTEAU HERRIOT |
Sale | $1.5M |
| 2026-08-07 | TABUTEAU HERRIOT |
Sale | $0 |
| Date | Drug | Type | Run-up 30d | Decision 1d | After 5d |
|---|---|---|---|---|---|
| 2026-04-30 | — | sNDA | +14.6% | +12.9% | +21% |
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