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PepGen stockholders elect three Class I directors, ratify KPMG as auditor
Howard Mayer, M.D. elected with 36.1M votes for, 8.5M withheld; Joshua Resnick and Lisa Wyman also elected.
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PepGen updates corporate presentation for IDMC meeting; no specific news disclosed
PepGen to present at 15th International Myotonic Dystrophy Consortium (May 26-30, 2026).
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PepGen Q1 net loss $17.8M; cash $132.3M; 10 mg/kg DM1 cohort fully enrolled
Net loss of $17.8M ($0.26 per share) vs $30.2M loss in Q1 2025; R&D spend down to $13.0M from $25.4M.
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PepGen reports positive Phase 2 FREEDOM2 data for PGN-EDODM1 in DM1; splicing correction 22.9% ex-outlier
5 mg/kg cohort (n=8): mean splicing correction 7.3% overall, 22.9% excluding outlier; placebo 6.8%.
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PepGen reports FY2025 net loss $89.7M; FDA partial hold on FREEDOM2 trial
FDA placed partial clinical hold on FREEDOM2-DM1 Phase 2 trial of PGN-EDODM1; questions relate to preclinical studies, not clinical data.
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PepGen furnishes updated corporate presentation for March 2026; no specific financial or operational details disclosed
Filed under Regulation FD to update corporate presentation (Exhibit 99.1).
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PepGen appoints Joseph Vittiglio as Chief Business and Legal Officer
Joseph Vittiglio named Chief Business and Legal Officer, effective December 8, 2025.
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PepGen reports Q3 net loss of $18.0M; 53.7% splicing correction in DM1 Phase 1
FREEDOM-DM1 15 mg/kg showed mean splicing correction of 53.7%, highest reported in DM1 patients.
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PepGen reprices underwater stock options to $4.53 for key employees including CEO, CFO, EVP
Repriced 3,557,903 shares held by employees and named executives; new exercise price $4.53.
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PepGen updates corporate presentation; content not provided in filing excerpt
Company provided an updated corporate presentation dated October 2025.
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PepGen Inc. prices $100 million public offering of 31.25 million shares at $3.20 per share
PepGen entered into underwriting agreement with Leerink Partners and Stifel to sell 31,250,000 shares at $3.20 per share.
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PepGen reports 53.7% mean splicing correction in DM1 patients at 15 mg/kg dose
Mean splicing correction of 53.7% at 15 mg/kg (n=6) by 22-gene panel at Day 28; all 6 patients responded.
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PepGen completes dosing in 15 mg/kg cohort of FREEDOM-DM1; net loss narrows to $23.1M
On track to report topline safety and splicing data from 15 mg/kg cohort in early Q4 2025.
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PepGen stockholders elect three Class III directors, ratify KPMG as auditor
Mitchell H. Finer elected with 27,224,040 votes for; 2,082,233 broker non-votes.
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PepGen discontinues DMD program after PGN-EDO51 misses dystrophin target; shifts focus to DM1
10 mg/kg PGN-EDO51: total dystrophin only 0.59% of normal (mean increase 0.36%); exon skipping +3.5%.
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PepGen Q1 2025 net loss $30.2M; DM1 splicing correction 29.1% at 10 mg/kg
Net loss $30.2M ($0.92/share) in Q1 2025 vs. $18.0M ($0.63/share) in Q1 2024.
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PepGen expands board to eight with appointments of Finer and Wyman
Mitchell Finer (PhD), former CSO at bluebird bio, and Lisa Wyman, CTO at Scholar Rock, join board.
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PepGen CMO Michelle Mellion resigns, effective April 4, 2025
Michelle L. Mellion, MD, resigned as Chief Medical Officer; departure effective April 4, 2025.
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PepGen voluntarily pauses Phase 2 CONNECT2-EDO51 study; awaits 10 mg/kg data from CONNECT1
Temporarily pauses CONNECT2-EDO51 in DMD until review of 10 mg/kg data from ongoing CONNECT1-EDO51 study.
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PepGen reports robust splicing correction in DM1 trial; 29.1% mean correction at 10 mg/kg single dose
Mean splicing correction of 12.3% (5 mg/kg, n=6) and 29.1% (10 mg/kg, n=4) at 28 days post single dose.
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PepGen gets FDA clinical hold on CONNECT2 U.S. trial; Health Canada restricts dose escalation in CONNECT1
10 mg/kg cohort fully enrolled (n=4); data expected year-end 2025.
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PepGen receives FDA clinical hold for Phase 2 DMD trial IND
FDA issued clinical hold for IND to initiate CONNECT2-EDO51 Phase 2 study of PGN-EDO51 in DMD patients.
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PepGen Q3 net loss $21.4M; cash $138.9M; DM1/DMD trial updates expected 2025
Net loss of $21.4M ($0.66 per share) vs $23.3M ($0.98) in Q3 2023.
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PepGen reports favorable safety profile for PGN-EDO51 in Phase 2 DMD trial at WMS Congress
CONNECT1-EDO51 safety data as of Oct 3: no serious adverse events; all treatment-related AEs mild and resolved.
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PepGen board member Christopher Ashton to retire effective Sept 30; board size reduced to 6
Christopher Ashton, PhD, voluntarily resigns from board, effective Sept 30, 2024; also leaves audit and compensation committees.
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PepGen appoints Paul Streck, M.D., MBA as EVP, Head of Research & Development
Appoints Paul Streck, M.D., MBA as EVP, Head of R&D effective immediately, joining PepGen Executive Team.
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PepGen reports Q2 2024 net loss $28.3M; PGN-EDO51 shows 2.15% exon skipping in CONNECT1
Net loss $28.3M ($0.87/sh) for Q2 2024 vs $19.5M ($0.82/sh) YoY; cash $161.3M, runway into 2026.
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PepGen announces positive Phase 2 data for PGN-EDO51 in DMD: exon skipping 2.15%, dystrophin increase
PGN-EDO51 5 mg/kg achieved mean exon skipping of 2.15% in biceps tissue at week 13 (n=3).
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PepGen appoints Afsaneh Mohebbi, Ph.D. as SVP Portfolio & Program Mgmt and Dave Borah, CFA as SVP IR & Corp Comms
Afsaneh Mohebbi, Ph.D. appointed SVP, Portfolio & Program Management; previously consultant to PepGen since Jan 2024.
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PepGen stockholders approve officer exculpation amendment and elect directors at annual meeting
Stockholders approved Certificate of Amendment to limit liability of certain officers under Delaware law; effective June 20, 2024.
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PepGen promotes Michelle Mellion to CMO, Hayley Parker to SVP Global Regulatory Affairs
Michelle Mellion, M.D., promoted to Chief Medical Officer effective immediately.
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PepGen Q1 net loss $18.0M, cash $175.2M; key clinical data expected mid-2024
Cash and marketable securities $175.2M as of March 31, 2024, funding operations into 2026.
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PepGen amends bylaws to update proxy rules and stockholder meeting procedures
Board adopted Second Amended and Restated By-laws effective March 15, 2024.
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PepGen receives FDA orphan drug and rare pediatric disease designations for DMD candidate PGN-EDO51
FDA granted orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapy for DMD.
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PepGen reports FY2023 net loss $78.6M; cash runway into 2026 after $80M offering
Enrollment complete for PGN-EDO51 5 mg/kg cohort; preliminary data expected mid-2024.
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PepGen gets UK MHRA clearance to start Phase 2 trial of PGN-EDO51 for DMD
MHRA authorized CTA for CONNECT2-EDO51 Phase 2 trial of PGN-EDO51 in DMD patients amenable to exon 51 skipping.
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PepGen gets FDA Fast Track for PGN-EDODM1 in DM1; Phase 1 data due 2024
FDA granted Fast Track designation for PGN-EDODM1 targeting myotonic dystrophy type 1 (DM1).
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PepGen prices $80.1M common stock offering of 7.53M shares at $10.635 per share
Gross proceeds ~$80.1M; net proceeds ~$76.4M after underwriting discounts and expenses.
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PepGen appoints Mary Beth DeLena as General Counsel and Secretary
Mary Beth DeLena joins PepGen as General Counsel and Secretary, effective January 17, 2024.
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PepGen doses first patient in Phase 2 CONNECT1-EDO51 trial for Duchenne muscular dystrophy
First patient dosed in open-label, multiple ascending dose Phase 2 trial of PGN-EDO51 in DMD patients amenable to exon 51 skipping.
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PepGen doses first patient in Phase 1 FREEDOM-DM1 trial; data expected in 2024
First patient dosed in Phase 1 FREEDOM-DM1 trial of PGN-EDODM1 for myotonic dystrophy type 1.
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PepGen appoints Howard Mayer, M.D. to board of directors
Howard Mayer appointed to PepGen board effective Nov 15, 2023; fills newly created vacancy expanding board to seven members.
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PepGen Q3 2023 net loss $23.3M; cash $129.5M; FDA clears FREEDOM-DM1 study in US
Net loss of $23.3M for Q3 2023, vs $18.6M in Q3 2022; R&D expenses $20.5M.
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FDA lifts clinical hold on PepGen's DM1 program; US Phase 1 trial to begin
FDA cleared IND for FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in DM1 patients in the US.
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PepGen reports preclinical data: PGN-EDODM1 corrects 99% of mis-splicing in DM1 mouse model
EDO platform delivers 25-fold higher oligonucleotide to myotube nuclei vs naked in vitro.
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PepGen receives Health Canada clearance to begin Phase 1 study of PGN-EDODM1 in DM1; FDA grants Orphan Drug Designation
Health Canada issued No Objection Letter for CTA to start FREEDOM-DM1 Phase 1 trial of PGN-EDODM1 in myotonic dystrophy type 1.
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PepGen Q2 net loss $19.5M; cash $147M; FDA clinical hold on DM1 trial continues
Net loss of $19.5M for Q2 2023 vs $17.3M YoY; R&D expense $16.9M, G&A $4.2M.
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PepGen enters ATM equity offering agreement for up to $100M in common stock
Entered ATM sales agreement with Stifel to sell up to $100M of common stock at market prices.
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PepGen stockholders elect Ashton and Resnick as directors, ratify KPMG as auditor
Christopher Ashton elected with 22,342,065 votes for, 78,780 withheld.
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PepGen withdraws PGN-EDODM1 Phase 1 timeline guidance pending FDA clinical hold
Withdrawing prior guidance to initiate a Phase 1 study of PGN-EDODM1 in DM1 in H1 2023.