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Passage Bio, Inc. (NASDAQ: PASG) is a pioneering genetic medicines company dedicated to the development of transformative therapies for rare monogenic central nervous system (CNS) diseases. Leveraging cutting-edge gene therapy techniques, Passage Bio is advancing a robust pipeline aimed at addressing unmet medical needs in both pediatric and adult CNS disorders.
The company's key initiatives include the development of PBGM01 for infantile GM1 gangliosidosis, PBFT02 for frontotemporal dementia (FTD) caused by progranulin deficiency, and PBKR03 for infantile Krabbe disease. These therapies utilize proprietary adeno-associated virus (AAV) capsids to deliver functional genes directly to the brain and peripheral tissues, promising significant therapeutic benefits.
Passage Bio collaborates with leading institutions to bolster its research and development efforts. This includes a strategic research partnership with the University of Pennsylvania's Gene Therapy Program and a collaboration agreement with Catalent Maryland, Inc. Such alliances enhance Passage Bio's capacity to innovate and expedite the clinical development of its promising therapies.
Financially, Passage Bio is in a strong position, with a cash runway extending into the fourth quarter of 2025, allowing the company to diligently progress its clinical programs. Recent achievements include positive interim data from the Imagine-1 study, a Phase 1/2 clinical trial of PBGM01, demonstrating a favorable safety profile and initial evidence of efficacy in early and late infantile GM1 gangliosidosis.
Additionally, the company is making strides with PBFT02. Initial data from the upliFT-D clinical trial indicate promising safety and biomarker outcomes, showing elevated cerebrospinal fluid (CSF) progranulin levels. Such results underscore the potential of PBFT02 to address the underlying pathology of FTD and other neurodegenerative conditions.
Passage Bio is also committed to fostering the next generation of scientists through initiatives like the Tachi Yamada Scholarship program, which supports students in life sciences disciplines.
Passage Bio (Nasdaq: PASG) announced FDA clearance for its IND application for PBKR03, a gene therapy targeting early infantile Krabbe disease, with clinical trials expected to start in 1H21. Krabbe disease, a rare CNS disorder, lacks approved therapies, highlighting the urgency of this development. PBKR03 utilizes a proprietary AAV capsid for gene delivery, aiming to restore GALC activity in affected patients. Preclinical studies show promising results, indicating potential for improved myelination and survival rates.
Passage Bio, Inc. (Nasdaq: PASG) announced FDA clearance for the IND application of PBFT02, a gene therapy for Frontotemporal Dementia (FTD) with GRN mutations, a condition with no approved disease-modifying treatments. Preclinical data from the University of Pennsylvania demonstrated PBFT02’s potential to elevate PGRN levels in the brain and cerebrospinal fluid while reducing lysosomal storage lesions. A Phase 1/2 clinical trial is expected to commence in H1 2021, focusing on safety, tolerability, and biomarker assessment, with initial data anticipated by late 2021 or early 2022.
Passage Bio, Inc. (Nasdaq: PASG) has priced its public offering of 7 million shares of common stock at $22.00 per share, aiming to raise $154 million in gross proceeds. The offering, which includes a 30-day option for underwriters to purchase an additional 1.05 million shares, is expected to close around January 26, 2021. The proceeds will support the company's efforts in gene therapies for rare central nervous system disorders. J.P. Morgan, Goldman Sachs, and Cowen are the joint bookrunning managers for the offering.
Passage Bio (Nasdaq: PASG) has announced a public offering of 7,000,000 shares of its common stock, with an additional 1,050,000 shares available through underwriters' options. This offering is intended to raise capital for the company's operations focusing on gene therapies for rare neurological disorders. J.P. Morgan, Goldman Sachs, and Cowen are managing the offering. The registration is pending approval from the SEC, and the offering's completion is uncertain.
Passage Bio (Nasdaq: PASG) announced a series of virtual Research & Development events for 2021, starting on January 25. The first event will focus on the investigational therapy PBGM01 targeting infantile GM1 gangliosidosis. Presenters include CEO Bruce Goldsmith, Chief Scientific Advisor James M. Wilson, and Chief Medical Officer Gary Romano, who will discuss the therapy's development and trial design. GM1 is a rare genetic disorder with a life expectancy of 2-4 years for infants. PBGM01 aims to deliver a functional GLB1 gene to mitigate neurodegeneration.
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.
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