Phase 2Data readout

PGN-EDODM1

Myotonic Dystrophy Type 1 (DM1)

PEPGPepGen

Expected catalystNovember 30, 2026Company guidance: Nov 30, 2026

Catalyst overview

Event details

Drug or asset: PGN-EDODM1
Development stage: Phase 2
Event type: Data readout
Indication: Myotonic Dystrophy Type 1 (DM1)

Research signalsBig moverHigh management interest

Research summary

What is being tracked?

This catalyst tracks a Phase 2 data readout for PGN-EDODM1 in Myotonic Dystrophy Type 1 (DM1). The expected timing is based on the latest available company guidance and may change.

Development notes

FREEDOM-DM1 study. 12/18/23- First patient dosed. 2/24/25- Reported initial results. 8/7/25- Completed dosing in 15mg/kg cohort. 9/24/25- Topline data reported 15 mg/kg dose cohort. Ph2 FREEDOM2 (MAD) trial data in Q1 2026. Presentation at WMS'25 on October 7-12, 2025. 11/12/25:- 5mg/kg cohort fully enrolled; Q1 2026 data, Q1 2026 10mg/kg dosing start, H2 2026 10mg/kg data. 03/04/26:- FREEDOM2 5mg Q1 2026 and 10mg H2 2026 data expected; MDA 2026 FREEDOM-DM1 results; US partial hold. Partial U.S. clinical hold; ex-U.S. sites cleared; 10 mg/kg dosing continues; data remains Q1 2026 and H2 2026. 03/31/26:- Reported Ph2 FREEDOM2 5mg MAD cohort data. 10mg MAD cohort results expected H2 2026. 05/12/26:- 10mg cohort fully enrolled; H2 2026 data; 12.5mg MAD data in 2027; OLE enrolling internationally. 05/21/26:- Present SAD and initial MAD data May 26, 2026. IDMC-15 mis-splicing analyses May 27-28, 2026. 08/06/26:- Reiterated 10mg data in November 2026, 12.5mg results H1 2027, OLE update Early January.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

What is being tracked?

This catalyst tracks a Phase 2 data readout for PGN-EDODM1 in Myotonic Dystrophy Type 1 (DM1). The expected timing is based on the latest available company guidance and may change.