Next issueIssue 23 · Tue 17 Nov 

Companies

Helus Pharma

HQ
Ireland
Status
active
Listing
Private
Current stage
Phase 3: APPROACH enrolled 223 (July 2026), topline guided Q4 2026; EMBRACE enrolling; NDA guided 2028
Key people
Parent Helus Pharma Inc.: Michael Halstead (CEO); Mark Lawson (independent Chair); co-founders Eric So (Chairman Emeritus) and Paul Glavine stepped down from executive and consulting roles and remain directors; Suresh Durgam director (Form 3 filed 2026-11-02, period of report 2026-10-16)

sec.govregistryverified 2026-11-07

Notes on the record

Supersedes the row verified 2026-11-02 (kept), per DATA LAYER rule 4. Changed: key_people, source_url. DATE DISCREPANCY: the earlier row and the Issue 21 facts pack give the co-founders' departure and the Chair change as 2026-10-27. Helus Material Change Report (6-K 0001833141-26-000094, EX-99.1, dated 2026-11-05) gives 'Date of Material Change: October 26, 2026' and 'effective October 26, 2026' for the Chair appointment; the news release was disseminated 2026-10-27 (Schedule A: 'Oct. 27, 2026'). Both dates are on the primary documents; 26 October is the effective date, 27 October the announcement. Read 2026-11-07 HTTP 200 (sha256 prefix 9eb2d57e7437). Form 3 0000912282-26-001414 (accepted 2026-11-02T18:27:35Z): Suresh K. Durgam, director, no securities owned, period of report 2026-10-16. 6-K 0001062993-26-005696 (2026-11-03): Guggenheim Healthcare Innovation Conference fireside chat 2026-11-09 15:00 EDT. Legal name, registry and sponsor-of-record notes unchanged.

Assets

  • HLP003

    Phase 3: APPROACH (NCT06564818, US only) COMPLETED on ClinicalTrials.gov, primary completion 2026-09-04 ACTUAL, study completion 2026-10-23 ACTUAL, 223 enrolled, no results posted; EMBRACE (NCT06793397) recruiting; EXTEND (NCT06605105) enrolling by invitation · major depressive disorder

    sec.govregistryverified 2026-11-07

Registered trials

  • NCT06605105ClinicalTrials.gov

    PHASE3 · Major Depressive Disorder · ENROLLING_BY_INVITATION · Australia, Greece, Poland, United Kingdom, United States

    clinicaltrials.govctgov registryverified 2026-10-13

  • NCT06793397ClinicalTrials.gov

    PHASE3 · Major Depressive Disorder (MDD);Depression in Adults;Depression - Major Depressive Disorder;Depression Disorders;Depression Disorder;Depression · RECRUITING · Australia, Czechia, Germany, Greece, Ireland, Poland, United Kingdom, United States

    clinicaltrials.govctgov registryverified 2026-10-06

  • 2024-516805-22-00CTIS

    Therapeutic confirmatory (Phase III) · Major Depressive Disorder · Authorised · Czechia, Germany, Greece, Ireland, Poland

    euclinicaltrials.euctis registryverified 2026-08-31

  • 2024-519270-40-00CTIS

    Therapeutic confirmatory (Phase III) · Major Depressive Disorder · Authorised · Czechia, Germany, Greece, Ireland, Poland

    euclinicaltrials.euctis registryverified 2026-11-07

Deals

This company is not a party to any row in data/deals.csv.

In the briefing

4 issues tagged CYBIN.

Record history