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 |
|---|---|---|---|---|---|
| 2026-12-22 | — | hypertension in combination with other antihypertensive drug | NDA | 69% | ±47% by Jan 15 |
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 |
|---|---|---|---|
| Lorundrostat | Hypertension | Phase 3 · NCT05968430 | Active not recruiting |
| lorundrostat Dose 1 | Hypertension | Phase 3 · NCT06153693 | Completed |
| lorundrostat Dose 2 | Hypertension | Phase 3 · NCT06153693 | Completed |
| MLS-101 (Part I) | Hypertension, Renal | Phase 2 · NCT05001945 | Completed |
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
MLYS holds $661.4M in cash and short-term investments (as of Jun 30, 2026) and burns about $36M/quarter from operations, an estimated runway of 55.1 months at that rate (BioRadar estimate, not company guidance).
Dilution pressure: 54 · 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 MLYS files for a raise →
| Holder | Type | Shares | % of shares | As of |
|---|---|---|---|---|
| Catalys Pacific Fund, LP | 5%+ holder (13G) | 8,002,738 | 9.05% | 2025-12-31 |
| Catalys Pacific, LLC | Institution (13F) | 7,903,838 | 8.94% | 2026-06-30 |
| Brian Taylor Slingsby Director · +8,300 options |
Insider | 7,805,718 | 8.83% | 2026-09-22 |
| Srinivas Akkaraju Director, 10% owner · +8,300 options |
Insider | 5,877,218 | 6.65% | 2026-02-19 |
| Samsara BioCapital, LLC | Institution (13F) | 5,871,018 | 6.64% | 2026-06-30 |
| FMR LLC | Institution (13G, 5%+) | 4,461,689 | 5.05% | 2026-06-30 |
| State Street Corporation | Institution (13F) | 4,141,636 | 4.68% | 2026-06-30 |
| BlackRock, Inc. | Institution (13G, 5%+) | 4,113,657 | 4.65% | 2025-12-31 |
| Deerfield Management Company, L.P | Institution (13F) | 3,958,000 | 4.48% | 2026-06-30 |
| Vanguard Capital Management LLC | Institution (13F) | 2,756,770 | 3.12% | 2026-06-30 |
| Laurion Capital Management, LP | Institution (13F) | 2,506,152 | 2.83% | 2026-06-30 |
| Price (T.Rowe) Associates Inc | Institution (13F) | 2,262,476 | 2.56% | 2026-06-30 |
Share count 88,406,885 (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 |
|---|---|---|---|---|---|
| 2026-09-22 filed 2026-09-24 |
Slingsby Brian Taylor |
Sale (S) | 104,320 | $28.81 | 7,805,718 |
| 2026-09-21 filed 2026-09-22 |
Warren Eric |
Option exercise (M) | 7,438 | – | – |
| 2026-09-21 filed 2026-09-22 |
Warren Eric |
Option exercise (M) | 7,438 | $13.24 | 45,838 |
| 2026-09-21 filed 2026-09-22 |
Warren Eric |
Sale (S) | 7,438 | $28.12 | 38,400 |
| 2026-09-15 filed 2026-09-17 |
Karydas Daphne |
Option exercise (M) | 3,000 | – | – |
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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