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PepGen Announces Clinical Hold in the U.S. on IND Application to Initiate CONNECT2-EDO51 Phase 2 Study of PGN-EDO51 for Duchenne Muscular Dystrophy
Monday, 16th December at 8:00 am
-Company continues to advance PGN-EDO51 in CONNECT1-EDO51, with the 10 mg/kg cohort now fully enrolled-
PepGen Inc. (NASDAQ: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application to initiate the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy (DMD). The FDA indicated they will provide an official clinical hold letter to the Company within 30 days.
CONNECT2 is PepGen's Phase 2 multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial of PGN-EDO51 in patients with DMD. The study is open in the United Kingdom.
"We intend to work closely with the FDA to address their questions on our application to initiate CONNECT2 as expeditiously as possible," said Paul Streck, MD, MBA, Head of R&D of PepGen. "Our open-label CONNECT1-EDO51 multiple ascending dose study of PGN-EDO51 in boys and young men living with DMD continues as planned in Canada. We have completed enrollment of the 10 mg/kg dose cohort; all four patients in this cohort have received at least one do
Monday, 16th December at 8:00 am
-Company continues to advance PGN-EDO51 in CONNECT1-EDO51, with the 10 mg/kg cohort now fully enrolled-
PepGen Inc. (NASDAQ: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application to initiate the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy (DMD). The FDA indicated they will provide an official clinical hold letter to the Company within 30 days.
CONNECT2 is PepGen's Phase 2 multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial of PGN-EDO51 in patients with DMD. The study is open in the United Kingdom.
"We intend to work closely with the FDA to address their questions on our application to initiate CONNECT2 as expeditiously as possible," said Paul Streck, MD, MBA, Head of R&D of PepGen. "Our open-label CONNECT1-EDO51 multiple ascending dose study of PGN-EDO51 in boys and young men living with DMD continues as planned in Canada. We have completed enrollment of the 10 mg/kg dose cohort; all four patients in this cohort have received at least one do
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