Dyne Therapeutics initiates registrational cohorts after positive Phase 1/2 DELIVER data; leadership changes

Dyne Therapeutics, Inc.

DYNE-251 (20 mg/kg Q4W) showed mean absolute dystrophin 3.71% of normal (unadjusted), >10x eteplirsen's 0.3% (cross-trial caution).
Functional improvement in NSAA, SV95C (met EMA MCID), 10-MWR, Time to Rise from Floor; 10 mg/kg cohort improved from 6 to 12 months.
Safety: favorable profile; no related SAEs except two at 40 mg/kg (resolved); >675 doses, >50 patient-years follow-up.
Leadership: CMO Wildon Farwell resigned; hired Doug Kerr as CMO, Johanna Friedl-Naderer as CCO, Lucia Celona as CHRO; CBO and COO also resigning.
Plans to update path to registration for DYNE-251 and DYNE-101 by end of 2024; ACHIEVE trial safety favorable up to 6.8 mg/kg Q8W.

item 5.02 item 7.01 item 8.01 item 9.01

Executive movements

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Departed

Jonathan McNeill, M.D.

Chief Business Officer

DYN · Dyne Therapeutics, Inc.

Effective: 2024-09-03
Filed: September 3, 2024, 7:59 PM ET

Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.

Departed

Susanna High

Chief Operating Officer

DYN · Dyne Therapeutics, Inc.

Effective: 2024-10-01
Filed: September 3, 2024, 7:59 PM ET

Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.

Key facts

Extracted from this filing and checked against the source text.

Executive change SEC 8-K Item 5.02 confidence 1.0

Jonathan McNeill, M.D. resigned as Chief Business Officer at Dyne Therapeutics, Inc..

Action: resigned
Role: Chief Business Officer

Exact text from the filing

Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.

View on SEC.gov

Executive change SEC 8-K Item 5.02 confidence 1.0

Susanna High resigned as Chief Operating Officer at Dyne Therapeutics, Inc..

Action: resigned
Role: Chief Operating Officer

Exact text from the filing

Jonathan McNeill, M.D., the Company’s Chief Business Officer, and Susanna High, the Company’s Chief Operating Officer, each notified the Company of their intention to resign their employment.

View on SEC.gov

Dyne Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001193125-24-211534

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