Company guidance, FDA catalysts, dilution risk and cash runway, built from SEC, FDA and ClinicalTrials.gov filings and updated every day.
We send one confirmation email first. Only emails about SMMT, unsubscribe in one click. Privacy
| PDUFA Date | Drug | Indication | Type | PoA | Options-implied move |
|---|---|---|---|---|---|
| 2026-11-14 | — | EGFRm NSCLC Post-TKI Therapy BLA Filing Based on HARMONi Glo | BLA | 64% | ±30% by Nov 20 |
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 2). 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 |
|---|---|---|---|
| Ligufalimab (AK117) | Squamous Cell Carcinoma Head and Neck Cancer (HNSC | Phase 3 · NCT07264075 | Recruiting |
| Ivonescimab RP3D | Metastatic Urothelial Carcinoma | Phase 2/3 · NCT07815665 | Recruiting |
| Ivonescimab (AK112) | Non-Small Cell Lung Cancer | Phase 3 · NCT05899608 | Recruiting |
| Ridinilazole | Clostridioides Difficile Infection | Phase 3 · NCT04802837 | Terminated |
| Ivonescimab Dose 2 | Metastatic Urothelial Carcinoma | Phase 2/3 · NCT07815665 | Recruiting |
| Vancomycin | Clostridioides Difficile Infection | Phase 3 · NCT04802837 | Terminated |
| Ivonescimab Dose 1 | Metastatic Urothelial Carcinoma | Phase 2/3 · NCT07815665 | Recruiting |
| Nebivolol Ophthalmic Suspension 0.5 Perc | Open-Angle Glaucoma | Phase 2 · NCT04910100 | Completed |
| Nebivolol Ophthalmic Suspension 1 Percen | Open-Angle Glaucoma | Phase 2 · NCT04910100 | Completed |
| Osimertinib | Non-Small Cell Lung Cancer | Phase 1/2 · NCT07535437 | Recruiting |
| Nab-paclitaxel | Non Small Cell Lung Cancer | Phase 2 · NCT07234877 | Not yet recruiting |
| Timolol Ophthalmic Solution 0.5 Percent | Open-Angle Glaucoma | Phase 2 · NCT04910100 | Completed |
| Timolol Ophthalmic Suspension 0.5 Percen | Open-Angle Glaucoma | Phase 2 · NCT04910100 | Completed |
| Zoldonrasib | Advanced Solid Tumors | Phase 1/2 · NCT07397338 | Recruiting |
| Datopotamab Deruxtecan | Non-Small Cell Lung Cancer | Phase 1/2 · NCT07535437 | Recruiting |
| Elironrasib | Advanced Solid Tumors | Phase 1/2 · NCT07397338 | Recruiting |
Also used in these trials (approved or third-party drugs, not SMMT's own candidates): Pembrolizumab, Enfortumab Vedotin, Oxaliplatin, Leucovorin, Paclitaxel, Pemetrexed Disodium, Daraxonrasib, Bevacizumab, Capecitabine, Carboplatin, Cetuximab, Docetaxel Anhydrous.
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
SMMT holds $1B in cash and short-term investments (as of Jun 30, 2026) and burns about $131.7M/quarter from operations, an estimated runway of 23.4 months at that rate (BioRadar estimate, not company guidance).
Dilution pressure: 53 · Elevated
These conditions raise substantial doubt about the Company’s ability to continue as a going concern.10-Q, Jul 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 SMMT files for a raise →
| Holder | Type | Shares | % of shares | As of |
|---|---|---|---|---|
| Robert W Duggan Co-Chief Executive Officer, Director, 10 · +16.43M options |
Insider | 610,015,809 | 76.47% | 2026-06-12 |
| Mahkam Zanganeh Co-Chief Executive Officer, Director, 10 · +11.05M options |
Insider | 610,015,809 | 76.47% | 2026-06-12 |
| Baker Bros. Advisors, LP | Institution (13F) | 32,786,348 | 4.11% | 2026-06-30 |
| Yu Xia Director · +40,438 options |
Insider | 32,057,147 | 4.02% | 2025-10-21 |
| FMR, LLC | Institution (13F) | 10,043,947 | 1.26% | 2026-06-30 |
| State Street Corporation | Institution (13F) | 9,536,796 | 1.20% | 2026-06-30 |
| Blackrock Inc. | Institution (13F) | 9,529,041 | 1.19% | 2026-06-30 |
| Vanguard Capital Management LLC | Institution (13F) | 5,734,484 | 0.72% | 2026-06-30 |
| UBS Group AG | Institution (13F) | 5,233,798 | 0.66% | 2026-06-30 |
| Vanguard Portfolio Management LLC | Institution (13F) | 5,042,190 | 0.63% | 2026-06-30 |
| Goldman Sachs Group Inc | Institution (13F) | 4,513,399 | 0.57% | 2026-06-30 |
| Price (T.Rowe) Associates Inc | Institution (13F) | 3,893,820 | 0.49% | 2026-06-30 |
Share count 797,749,602 (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 |
|---|---|---|---|---|---|
| 2026-06-12 filed 2026-06-12 |
DUGGAN ROBERT W |
Purchase (P) | 3,810,000 | $13.12 | 573,883,879 |
| 2026-06-12 filed 2026-06-12 |
Zanganeh Mahkam |
Purchase (P) | 3,810,000 | $13.12 | 573,883,879 |
| 2026-06-04 filed 2026-06-04 |
Soni Manmeet Singh |
Purchase (P) | 25,000 | $14.43 | 3,123,603 |
| 2026-06-04 filed 2026-06-04 |
Soni Manmeet Singh |
Purchase (P) | 25,000 | $14.46 | 3,098,603 |
| 2026-06-04 filed 2026-06-04 |
Zanganeh Mahkam |
Purchase (P) | 100,000 | $14.60 | 25,824,474 |
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 |
|---|---|---|---|---|---|
| 2026-02-23 | — | BLA | -5.4% | +0.9% | +4.1% |
The 7-day free trial adds AI daily briefings, sentiment tracking, trial enrollment progress and email alerts for SMMT and every other ticker you follow. Card required, cancel anytime.
Start 7-day free trial →