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 | Options-implied move |
|---|---|---|---|---|---|
| 2026-12-12 | — | BLA | 64% | ±40% by Dec 18 |
Options-implied move = price of the at-the-money straddle for the first option expiry after the PDUFA date, as a share of the stock price (Yahoo Finance quotes, Oct 1). It prices every move until that expiry, not only the FDA decision.
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 →
Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.
| Drug | Indication | Most advanced trial | Status |
|---|---|---|---|
| Iloperidone FDA approved May 2009 · Fanapt |
Schizophrenia | Phase 4 · NCT05648591 | Recruiting |
| Tradipitant (VLY-686) FDA approved Dec 2025 · Nereus |
Idiopathic Gastroparesis | Phase 3 · NCT06836557 | Recruiting |
| Tasimelteon FDA approved Jan 2014 · Hetlioz |
Autism Spectrum Disorder | Phase 3 · NCT05361707 | Unknown |
| Ponesimod FDA approved Mar 2021 · Ponvory |
Ulcerative Colitis (UC) | Phase 3 · NCT07686081 | Recruiting |
| Milsaperidone FDA approved Feb 2026 · Bysanti |
Major Depressive Disorder (MDD) | Phase 3 · NCT06830044 | Recruiting |
| Teverelix | Generalized Pustular Psoriasis | Phase 3 · NCT05352893 | Completed |
| VQW-765 | Social Anxiety Disorder (SAD) | Phase 3 · NCT07221578 | Active not recruiting |
| Tasimelteon Oral Suspension | Insomnia Disorder | Phase 3 · NCT06953869 | Recruiting |
| Open Label Tradipitant | Idiopathic Gastroparesis | Phase 3 · NCT04028492 | Completed |
| Imsidolimab | Generalized Pustular Psoriasis | Phase 3 · NCT05366855 | Terminated |
| Trichostatin A | Onychomycosis of Toenail | Phase 2 · NCT07065773 | Active not recruiting |
| VCA-894A | Charcot Marie Tooth Disease (CMT) | Phase 1/2 · NCT07223632 | Active not recruiting |
| VSJ-110 | Dry Eye | Phase 2 · NCT07179055 | Recruiting |
| VHX-896 | Healthy | Phase 1 · NCT06803290 | Completed |
| Active Control | Healthy Volunteers | Phase 1 · NCT06323655 | Completed |
Also used in these trials (approved or third-party drugs, not VNDA's own candidates): Ziprasidone.
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
VNDA holds $170M in cash and short-term investments (as of Jun 30, 2026) and burns about $40.6M/quarter from operations, an estimated runway of 12.6 months at that rate (BioRadar estimate, not company guidance).
Dilution pressure: 43 · Elevated
Recent financing filings on SEC EDGAR:
Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when VNDA files for a raise →
| Holder | Type | Shares | % of shares | As of |
|---|---|---|---|---|
| Blackrock Inc. | Institution (13F) | 7,653,737 | 12.66% | 2026-06-30 |
| AQR Capital Management, LLC | Institution (13G, 5%+) | 3,497,695 | 5.78% | 2026-06-30 |
| Renaissance Technologies, LLC | Institution (13F) | 3,441,361 | 5.69% | 2026-06-30 |
| Millennium Management LLC | Institution (13G, 5%+) | 3,376,401 | 5.58% | 2026-08-17 |
| STATE STREET CORPORATION | Institution (13G, 5%+) | 3,015,562 | 4.99% | 2026-03-31 |
| Mihael Hristos Polymeropoulos President and CEO, Director |
Insider | 2,704,496 | 4.47% | 2026-03-02 |
| Vanguard Capital Management LLC | Institution (13F) | 2,524,040 | 4.17% | 2026-06-30 |
| AIGH Capital Management LLC | Institution (13F) | 2,044,169 | 3.38% | 2026-06-30 |
| Acadian Asset Management. LLC | Institution (13F) | 1,918,063 | 3.17% | 2026-06-30 |
| Dimensional Fund Advisors LP | Institution (13F) | 1,727,349 | 2.86% | 2026-06-30 |
| Geode Capital Management, LLC | Institution (13F) | 1,483,787 | 2.45% | 2026-06-30 |
| Gunther Birznieks SVP, Business Development |
Insider | 494,197 | 0.82% | 2026-03-02 |
Share count 60,462,687 (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 total held by all 13F filers (Yahoo Finance); the table lists the largest (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 |
|---|---|---|---|---|---|
| 2026-06-04 filed 2026-06-08 |
Chrousos Phaedra |
Award (A) | 41,600 | – | 164,950 |
| 2026-06-04 filed 2026-06-08 |
Duncan Charles Cliff |
Award (A) | 41,600 | – | 98,701 |
| 2026-06-04 filed 2026-06-08 |
Ward Anne Sempowski |
Award (A) | 41,600 | – | 160,667 |
| 2026-06-04 filed 2026-06-08 |
Honore Tage |
Award (A) | 41,600 | – | 135,069 |
| 2026-06-04 filed 2026-06-08 |
Mitchell Stephen Ray |
Award (A) | 41,600 | – | 112,846 |
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.
| Date | Drug | Type | Run-up 30d | Decision 1d | After 5d |
|---|---|---|---|---|---|
| 2026-02-21 | — | NDA | -27.4% | +41.5% | +54.7% |
| 2025-12-30 | NEREUS™ (tradipitant) | NDA | +35.9% | -2.4% | +12.9% |
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