PureTech Health (PRTC): LYT-200 AML development

This situation live

PRTC PureTech Health

£279m · 110.0p · −17% since the first step

3 Nov 2025 · Phase 1b data maturing; Phase 2 planning · −6% until the next step PureTech intends to engage with regulatory authorities to advance LYT-200 into a Phase 2 trial.

5 Dec 2025 · Phase 1b topline reported; Phase 2 planned · −7% until the next step Gallop intends to engage with regulatory authorities to discuss the proposed Phase 2 dose and potentially registrational path after the overall survival data have fully matured.

2 Apr 2026 · Phase 1 PK proof-of-concept positive; MAD ongoing · +14% until the next step The completed SAD and crossover portions of the trial, which included approximately 130 participants, conclude the PK proof-of-concept objectives of the trial, while the ongoing multiple-ascending dos

22 Apr 2026 · Phase 1b complete; MDS prioritised, AML to follow · −3% until the next step Company plans to engage with the U.S. Food and Drug Administration to discuss the design of a subsequent trial in R/R HR-MDS that has the potential to support registration

29 Apr 2026 · Phase 2 dose chosen; seeking external capital · −3% until the next step Gallop intends to pursue third-party capital to support a potentially registration-enabling trial in R/R HR-MDS, with the round targeted to close in the first quarter of 2027.

21 Sep 2026 · EOP1 done; Fast Track; Phase 2 design set · −7% until the next step PureTech intends to secure external capital in the first half of 2027 to support the continued development of LYT-200 through its Founded Entity, Gallop Oncology

22 Sep 2026 · Fast Track and Phase 2 design set; funding sought · −2% since PureTech intends to leverage external capital to support the continued development of LYT-200 through the completion of the Phase 2 STRIDE-MDS trial and expects to secure capital in the first half of

Project milestones

LYT-200 AML development

Fast Track and Phase 2 design set; funding sought

JUN30 Next: Secure external capital and start STRIDE-MDS in 249 days

Every step · 7

3 Nov 2025 Phase 1b data maturing; Phase 2 planning – PureTech intends to engage with regulatory authorities to advance LYT-200 into a Phase 2 trial. ↗
5 Dec 2025 Phase 1b topline reported; Phase 2 planned – Gallop intends to engage with regulatory authorities to discuss the proposed Phase 2 dose and potentially registrational path after the overall survival... ↗
2 Apr 2026 Phase 1 PK proof-of-concept positive; MAD ongoing – The completed SAD and crossover portions of the trial, which included approximately 130 participants, conclude the PK proof-of-concept objectives of the... ↗
22 Apr 2026 Phase 1b complete; MDS prioritised, AML to follow – Company plans to engage with the U.S. Food and Drug Administration to discuss the design of a subsequent trial in R/R HR-MDS that has the potential to... ↗
29 Apr 2026 Phase 2 dose chosen; seeking external capital – Gallop intends to pursue third-party capital to support a potentially registration-enabling trial in R/R HR-MDS, with the round targeted to close in the... ↗
21 Sep 2026 EOP1 done; Fast Track; Phase 2 design set – PureTech intends to secure external capital in the first half of 2027 to support the continued development of LYT-200 through its Founded Entity, Gallop Oncology ↗
22 Sep 2026 Fast Track and Phase 2 design set; funding sought – PureTech intends to leverage external capital to support the continued development of LYT-200 through the completion of the Phase 2 STRIDE-MDS trial and... ↗

What is happening

PureTech Health: LYT-200 AML development – Fast Track and Phase 2 design set; funding sought. ['Fast Track and Phase 2 design set; funding sought']

In short: LYT-200 Phase 1b is complete, with MDS prioritised over AML. On 21 Sep 2026 PureTech announced a successful FDA End-of-Phase 1 meeting and Fast Track designation in R/R HR-MDS, with the Phase 2 STRIDE-MDS design set. The 22 Sep 2026 half-year report repeats the plan to secure external capital in H1 2027; Gallop remains 100% owned.
Announced: 3 Nov 2025 · Phase 1b data maturing; Phase 2 planning
Latest: 22 Sep 2026 · Fast Track and Phase 2 design set; funding sought
Safety: N=101, no LYT-200-related serious AEs; six patients at one site with Grade 3/4 blood count AEs
Next milestone: Secure external capital, then start STRIDE-MDS; no trial start date stated
Financing: External capital expected in the first half of 2027, to fund through Phase 2 completion
FDA meeting: Successful End-of-Phase 1 meeting announced 21 Sep 2026; Fast Track designation for LYT-200 plus HMA in R/R HR-MDS
Phase 2 design: STRIDE-MDS: randomized, double-blind, placebo-controlled, about 125 patients; 12 mg/kg, 7.5 mg/kg or placebo, each plus HMA, 2:2:1
Funding: External capital expected in H1 2027 to fund through Phase 2 STRIDE-MDS completion
Ownership: PureTech holds 100% of Gallop Oncology
Regulatory: Successful End-of-Phase 1 meeting and Fast Track designation, announced September 2026

What comes next

Secure external capital and start STRIDE-MDS (30 Jun 2027).

From the company's own announcements. Not investment advice.

Briefing

PureTech Health in 4 minutes

PureTech Health is a London-listed biotech that invents drugs, then moves them into separately financed companies. Its model produced Cobenfy, a schizophrenia drug whose early backing of $18.5m returned about $1.1bn...

Act 1Karuna's $14bn sale and cash for shareholders
Act 2A good drug and a funding gap
Act 32026: outside money arrives

Read the briefing →

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