Company guidance, FDA catalysts, dilution risk and cash runway, built from SEC, FDA and ClinicalTrials.gov filings and updated every day.
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| PDUFA Date | Drug | Indication | Type | PoA |
|---|---|---|---|---|
| 2026-11-14 | — | agitation associated with Alzheimer’s dementia Evaluating st | sNDA | 76% |
PoA = estimated probability of approval: base rates calibrated against BioRadar's verified FDA outcomes, adjusted for application type, modality, therapy area and cash runway. Not investment advice. See the full PDUFA calendar →
| Drug | Indication | Most advanced trial | Status |
|---|---|---|---|
| Dexmedetomidine Hydrochloride FDA approved Apr 2022 · Igalmi |
Delirium | Phase 2 · NCT04382170 | Withdrawn |
| BXCL501 | Opioid Use Disorder | Phase 1/2 · NCT05712707 | Active not recruiting |
| Sublingual film containing Dexmedetomidi | Agitation,Psychomotor | Phase 1/2 · NCT04251910 | Completed |
| Talabostat (BXCL701) | Prostate Cancer | Phase 1/2 · NCT03910660 | Completed |
| Dexmedetomidine (DEX) for sublingual (SL | Alcohol Use Disorder (AUD) | Phase 1 · NCT06335407 | Recruiting |
| Dexmedetomidine (DEX) for sublingual (SL | Alcohol Use Disorder (AUD) | Phase 1 · NCT06335407 | Recruiting |
| Talabostat Mesylate | Cancer of Pancreas | Early Phase 1 · NCT04123574 | Withdrawn |
Also used in these trials (approved or third-party drugs, not BTAI's own candidates): Dexmedetomidine, Lorazepam, Pembrolizumab.
Source: ClinicalTrials.gov trials sponsored by the company, one row per candidate at its most advanced registered trial. FDA approvals: Drugs@FDA. Wrong or missing drug? Report it
BTAI holds $12.8M in cash and short-term investments (as of Jun 30, 2026) and burns about $9M/quarter from operations, an estimated runway of 4.3 months at that rate (BioRadar estimate, not company guidance).
Dilution pressure: 100 · High
We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.10-Q, Aug 2026
Recent financing filings on SEC EDGAR:
Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when BTAI files for a raise →
| Holder | Type | Shares | % of shares | As of |
|---|---|---|---|---|
| Millennium Management Llc | Institution (13F) | 2,114,710 | 6.76% | 2026-06-30 |
| Oaktree Capital Management LP | Institution (13F) | 1,380,248 | 4.41% | 2026-06-30 |
| Vanguard Capital Management LLC | Institution (13F) | 919,545 | 2.94% | 2026-06-30 |
| Oaktree Fund Advisors, LLC | Institution (13F) | 245,585 | 0.78% | 2026-06-30 |
| Geode Capital Management, LLC | Institution (13F) | 242,251 | 0.77% | 2026-06-30 |
| Blackrock Inc. | Institution (13F) | 179,433 | 0.57% | 2026-06-30 |
| UBS Group AG | Institution (13F) | 158,065 | 0.50% | 2026-06-30 |
| Citadel Advisors Llc | Institution (13F) | 149,220 | 0.48% | 2026-06-30 |
| Vanguard Fiduciary Trust Co | Institution (13F) | 136,937 | 0.44% | 2026-06-30 |
| State Street Corporation | Institution (13F) | 92,118 | 0.29% | 2026-06-30 |
Share count 31,305,499 (latest 10-Q/10-K). Insiders: each officer's, director's and 10% owner's latest Form 3, 4 or 5, direct and indirect shares; options are not counted. 5%+ holders: latest Schedule 13D or 13G of each holder above 5%. Institutions: the largest 13F holders (13F quarter ending 2026-06-30). Sources have different dates, so the split is approximate. Source: SEC EDGAR.
| Trade date | Insider | Transaction | Shares | Price | Owned after |
|---|---|---|---|---|---|
| 2026-08-12 filed 2026-08-14 |
Atkins Susan E. |
Option award (A) | 17,000 | – | – |
| 2026-06-15 filed 2026-06-17 |
Steinhart Richard I |
Option exercise (M) | 35 | – | – |
| 2026-06-15 filed 2026-06-17 |
Steinhart Richard I |
Option exercise (M) | 35 | – | 26,335 |
| 2026-05-20 filed 2026-05-22 |
Yocca Frank |
Sale (S) | 6,845 | $1.09 | 26,175 |
| 2026-05-20 filed 2026-05-22 |
Rodriguez Javier |
Sale (S) | 6,560 | $1.08 | 26,803 |
Only open-market purchases (P) and sales (S) are trading decisions. Awards (A), option exercises (M) and tax withholding (F) are compensation mechanics. Source: SEC Form 4.
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