Passage Bio, Inc. Stock Price, News & Analysis

Passage Bio (Nasdaq: PASG) has submitted IND applications for PBFT02 aimed at treating Frontotemporal Dementia with Granulin Mutation and PBKR03 for Krabbe Disease. The company plans to initiate three clinical studies in the first half of 2021. It is also advancing PBML04 for Metachromatic Leukodystrophy into IND-enabling studies. Passage Bio continues to collaborate with the University of Pennsylvania’s Gene Therapy Program, having licensed a total of 17 programs. A new manufacturing lab will open in Q2 2021 to enhance testing capabilities.

On January 4, 2021, Passage Bio (Nasdaq: PASG) announced that its CEO, Bruce Goldsmith, will present a company overview at the J.P. Morgan 39th Annual Healthcare Conference on January 11, 2021, at 7:30 AM ET. A live webcast of the presentation will be available on the company's website for 30 days. Passage Bio focuses on developing gene therapies for rare central nervous system disorders, leveraging collaboration with the University of Pennsylvania’s Gene Therapy Program to advance its pipeline.

Passage Bio (Nasdaq: PASG) announced FDA clearance for its PBGM01 gene therapy, targeting infantile GM1 gangliosidosis, marking a significant milestone. The global Phase 1/2 clinical trial, named Imagine-1, is set to dose its first patient in Q1 2021. GM1 is a rare CNS disorder affecting infants, with no approved therapies. The trial will enroll 8 patients across 4 cohorts to evaluate safety and biomarker data. PBGM01 aims to restore enzyme activity to mitigate neurodegeneration. The company has also obtained UK regulatory approval for the treatment.

Passage Bio (Nasdaq: PASG) announces a long-term lease for a new CMC laboratory at the Princeton West Innovation Campus in Hopewell, NJ, expected to open in Q2 2021. This facility aims to enhance internal manufacturing capabilities for gene therapy programs. The lab will focus on analytical capabilities, clinical assay development, and product testing, complementing a recently opened CGMP suite at Catalent. The expansion supports the company's strategy to advance its gene therapy pipeline, with plans to hire over 20 new positions in 2021.

Passage Bio has received approval from the UK’s Medicines Healthcare Products Regulatory Agency (MHRA) for the Clinical Trial Authorization (CTA) of its lead gene therapy candidate, PBGM01, aimed at treating GM1 gangliosidosis, a rare and life-threatening CNS disorder. This marks the initiation of the global PBGM01 clinical trial program, with patient enrollment in the UK expected to begin in Q2 2021. The Phase 1/2 trial will explore safety and efficacy through a single injection in pediatric patients and aims to report initial results by mid-2021.

Passage Bio has announced the commencement of manufacturing operations for its gene therapy product candidates following the completion of a dedicated Current Good Manufacturing Practice (CGMP) suite at Catalent's facility in Maryland. This marks a significant milestone in advancing therapies for rare monogenic CNS disorders, enabling better supply chain control and scalability. The partnership with Catalent allows for efficient production and distribution, enhancing the potential for clinical and commercial success.

Passage Bio (Nasdaq: PASG) announces that CEO Bruce Goldsmith will participate in a fireside chat at the Piper Sandler 32nd Annual Healthcare Conference from December 1 to 3, 2020. This virtual event enables registered attendees to view the chat on-demand. A recording will be accessible for 30 days on the company's Investors & Media webpage. Passage Bio focuses on developing gene therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania’s Gene Therapy Program to enhance its research and clinical pipeline.

Passage Bio has secured rights to innovative technology from the University of Pennsylvania’s Gene Therapy Program aimed at mitigating dorsal root ganglia (DRG) toxicity observed in gene therapy. This collaboration could enhance the safety of its gene therapy treatments for rare CNS disorders. Although safety studies have not indicated clinical manifestations of DRG toxicity, Passage Bio expresses optimism about integrating this new approach into its programs if it proves beneficial. The company anticipates initiating clinical trials for several programs in 2021.

Passage Bio (Nasdaq: PASG), a company specializing in genetic therapies for rare CNS disorders, will participate in two virtual investor conferences in November. The Guggenheim Virtual Healthcare Talks will take place on November 16, 2020, followed by the Stifel Virtual Healthcare Conference on November 18, 2020, where Passage Bio will present at 4:00 p.m. ET. The company is committed to developing innovative gene therapies in collaboration with the University of Pennsylvania's Gene Therapy Program.