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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) reports Q3 2024 financial results and business updates. The company has enrolled 4 patients in Cohort 2 of the upliFT-D trial for FTD-GRN, with dosing progressing as planned. Updated interim data from Cohort 1 showed PBFT02 was well-tolerated with elevated CSF progranulin levels for up to 12 months. Financial highlights include cash position of $84.8 million, R&D expenses of $8.7 million (down from $15.1 million YoY), and net loss of $19.3 million ($0.31 per share). The company expects current cash to fund operations through Q2 2026.
Passage Bio (NASDAQ: PASG), a clinical stage genetic medicines company specializing in neurodegenerative diseases, has announced its participation in the upcoming Guggenheim Securities Healthcare Innovation Conference. Will Chou, M.D., the company's president and CEO, will deliver a presentation on November 13, 2024, at 2:30 p.m. ET. The presentation will be accessible via live webcast on the company's investor relations website, with a replay available for 30 days after the event.
Passage Bio (NASDAQ: PASG) presented preclinical and interim clinical data for PBFT02, their gene therapy treatment for frontotemporal dementia (FTD-GRN), at the ESGCT 31st Annual Conference. Key findings showed that AAV1 vector achieved superior human progranulin levels compared to other vectors, and PBFT02 improved lysosomal histopathology and reduced neuroinflammation in test subjects.
The interim clinical data from the upliFT-D trial demonstrated that PBFT02 was well-tolerated and produced consistent, durable increases in CSF progranulin levels, maintained up to 12 months post-administration. The therapy showed promising results in achieving widespread vector distribution throughout the nervous system.
Passage Bio, a clinical stage genetic medicines company focused on neurodegenerative diseases, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. Will Chou, M.D., the company's president and CEO, will present on Tuesday, October 1, 2024, at 8:30 a.m. ET.
The presentation will be accessible via a live webcast on the Investors & Media section of Passage Bio's website at investors.passagebio.com. For those unable to attend the live event, a replay will be available for 30 days following the presentation.
Passage Bio is traded on the NASDAQ under the ticker symbol PASG.
Passage Bio (Nasdaq: PASG) will present updated data from its Phase 1/2 upliFT-D clinical trial of PBFT02, a gene therapy for frontotemporal dementia (FTD) with granulin mutations, at the 14th International Conference on Frontotemporal Dementias on September 20, 2024. The interim results from Cohort 1 (n=5) show that Dose 1 of PBFT02 was well-tolerated in patients receiving an enhanced immunosuppression regimen, with no serious adverse events observed.
Key findings include:
- Robust and durable increase in CSF progranulin (PGRN) expression, up to 6-fold at one month and 10-fold at six months
- CSF PGRN levels exceeded healthy adult control ranges
- Elevated CSF PGRN levels sustained up to 12 months post-treatment
- No evidence of dorsal root ganglion toxicity or clinically significant immune responses
These results suggest PBFT02's potential as a best-in-class progranulin-raising therapy for neurodegenerative diseases.
Passage Bio (Nasdaq: PASG) has appointed Tom Kassberg to its Board of Directors and Audit Committee. Kassberg, currently Chief Business Officer and Executive VP at Ultragenyx, brings extensive experience in strategic planning and corporate development. His background includes leadership roles at Proteolix, InterMune, Plexxikon, and SUGEN. Passage Bio CEO Will Chou highlighted Kassberg's expertise in advancing gene therapies for rare diseases, which aligns with the company's focus on neurodegenerative diseases. Kassberg expressed enthusiasm for joining Passage Bio, particularly noting the progress of the PBFT02 program and its potential expansion into additional indications.
Passage Bio (NASDAQ: PASG), a clinical stage genetic medicines company focusing on neurodegenerative diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's president and CEO, Will Chou, M.D., is scheduled to present on Monday, September 9, 2024, at 7:00 a.m. ET.
Investors and interested parties can access a live webcast of the presentation through the Investors & Media section of Passage Bio's website at investors.passagebio.com. For those unable to attend the live event, a replay will be available for 30 days following the presentation.
Passage Bio (Nasdaq: PASG) reported Q2 2024 financial results and business highlights. Key points include:
- Enrolled first FTD-GRN patient in Cohort 2 of upliFT-D trial
- FDA agreed to expand upliFT-D trial to include FTD-C9orf72 patients
- Out-licensed pediatric lysosomal storage disease programs to GEMMA Biotherapeutics
- Cash runway extended to end of Q2 2026
- Q2 2024 financials: $91.8M cash position, $10.4M R&D expenses, $6.5M G&A expenses, $16.0M net loss ($0.26 per share)
The company plans to present updated safety and biomarker data from Cohort 1 FTD-GRN patients at ISFTD2024 in September 2024 and expects to initiate dosing of FTD-C9orf72 patients in 1H 2025.
Passage Bio (NASDAQ: PASG), a clinical-stage genetic medicines company, has announced its participation in two upcoming investor conferences. The company will be present at the Canaccord Genuity 44th Annual Growth Conference on August 13, 2024, in Boston, MA, where management will give a presentation at 8:00 a.m. ET and participate in investor meetings. Additionally, Passage Bio will attend the 15th Annual Wedbush PacGrow Healthcare Conference on August 14, 2024, in New York City, NY, participating in investor meetings.
A live webcast of the Canaccord Genuity conference presentation will be available on the Investors & Media section of Passage Bio's website, with a replay accessible for 30 days following the event. This participation in investor conferences demonstrates Passage Bio's commitment to engaging with the investment community and sharing updates on their progress in developing treatments for neurodegenerative diseases.
Passage Bio (NASDAQ: PASG) has out-licensed three pediatric gene therapy programs to GEMMA Biotherapeutics, a new company co-founded by Dr. James M. Wilson. The deal includes exclusive, worldwide rights for PBGM01 (GM1 gangliosidosis), PBKR03 (Krabbe disease), and PBML04 (metachromatic leukodystrophy). Passage Bio will receive initial payments of $10 million, with potential for up to $124 million in additional milestones and future royalties.
The company also entered a new strategic research collaboration with GEMMA Biotherapeutics, focusing on CNS indications including Huntington's disease. This transaction is expected to extend Passage Bio's operating cash runway to the end of Q2 2026, allowing the company to focus on advancing its lead asset, PBFT02, in multiple adult neurodegenerative diseases.
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