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Passage Bio, Inc. develops clinical-stage genetic medicines for neurodegenerative diseases, with news centered on PBFT02 and the upliFT-D study in frontotemporal dementia. Company updates commonly address safety and biomarker data, progranulin and neurofilament light-chain measures, patient groups involving FTD-GRN and FTD-C9orf72, and FDA interactions tied to potential registrational development.
Recurring announcements also cover periodic financial results, corporate presentations, investor conference participation, manufacturing comparability work, and strategic or operating updates that affect the company's development plans and expense profile.
Passage Bio (Nasdaq: PASG) has published significant preclinical results supporting the development of its gene therapy PBKR03 for infantile Krabbe disease, a severe pediatric condition. The studies, in collaboration with the University of Pennsylvania, demonstrated marked safety improvements and positive effects on disease progression in animal models, with no dose-limiting toxicities observed. Passage Bio is now enrolling patients for the GALax-C clinical trial, aiming to evaluate the potential of PBKR03 to effectively treat this rare disease.
Passage Bio (NASDAQ: PASG) has announced its participation in three upcoming virtual investor conferences. The events include the Guggenheim 3rd Annual Genomic Medicines & Rare Disease Day on March 31, 2022, at 9:00 a.m. ET, the 21st Annual Needham Virtual Healthcare Conference on April 13, 2022, at 2:15 p.m. ET, and the Chardan Genetic Medicines and Cell Therapy Manufacturing Summit on April 26, 2022, at 11:30 a.m. ET. Live webcasts will be available on their website, with replays for 30 days post-event.
Passage Bio (Nasdaq: PASG) announced a strategic restructuring to extend its cash runway by reducing its workforce by 13% and focusing on key R&D programs. The company is advancing three clinical trials for GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia. The estimated cash runway is now extended into Q2 2024. Key leadership changes include the retirement of Chief Research and Development Officer Eliseo O. Salinas, effective March 18, 2022, with Mark Forman continuing to lead the trials. Upcoming milestones include patient dosing and IND submissions in 2022.
Passage Bio has initiated dosing in its global Phase 1/2 clinical trial, GALax-C, for PBKR03, a gene therapy for early infantile Krabbe disease. The first patient has received the treatment, with interim safety and biomarker data expected by the end of 2022. PBKR03, using a proprietary AAV capsid, aims to treat both central nervous and peripheral nervous symptoms. The FDA has granted it Fast Track and Orphan Drug designations, highlighting the urgent medical need as there are currently no approved treatments for Krabbe disease.
Passage Bio (PASG) reported positive interim data from its Imagine-1 clinical trial for GM1 gangliosidosis, achieving milestones in patient dosing. The company dosed patients in Cohorts 2 and 3, with expected interim data for both in the second half of 2022. Passage Bio ended 2021 with $315.8 million in cash, sufficient to fund operations through 2023. Increased R&D and G&A expenses were noted, leading to a net loss of $185.4 million for 2021. The pipeline has expanded with new programs for Canavan and Huntington’s diseases in collaboration with the University of Pennsylvania.
Passage Bio, Inc. (NASDAQ: PASG) has announced its participation in two upcoming virtual investor conferences in March 2022. The Cowen 42nd Annual Healthcare Conference will feature a panel on March 8 at 2:10 p.m. ET, while the Oppenheimer 32nd Annual Healthcare Conference will include a presentation on March 15 at 4:40 p.m. ET. Both events will be available via live webcast on the company's website, with replays accessible for 30 days. Passage Bio focuses on genetic medicines for CNS disorders, collaborating with the University of Pennsylvania to advance its research efforts.
Passage Bio (NASDAQ: PASG) announced a conference call on March 3, 2022, at 8:30 a.m. ET, to discuss its fourth quarter and full-year 2021 financial results and recent business highlights. The call can be accessed by dialing 833-528-0605 (domestic) or 830-221-9711 (international), using conference ID 4137048. A live audio webcast will also be available on Passage Bio's investor website. The company, focused on genetic therapies for CNS disorders, collaborates with the University of Pennsylvania to advance its gene therapy pipeline.
Passage Bio (Nasdaq: PASG) presented interim data from the Imagine-1 clinical trial for PBGM01, a gene therapy targeting GM1 gangliosidosis. Results show both children in Cohort 1 exhibited developmental improvements, evaluated through the Bayley III and Vineland II assessments. Low doses of PBGM01 were well tolerated with no serious adverse events or dorsal root ganglion toxicity reported. Cohorts 2 and 3 have commenced, with initial biomarker and safety data expected in 2H2022. A conference call was scheduled for February 11, 2022, to discuss findings.
Passage Bio (Nasdaq: PASG) will participate in the 18th Annual WORLD Symposium from February 7-11, 2022, presenting new clinical data from the Imagine-1 trial for GM1 gangliosidosis. Key presentations include a late-breaking science session on February 11, demonstrating safety and clinical milestones for two patients in Cohort 1. Additionally, the company will host a conference call post-presentation. Passage Bio is focused on developing genetic medicines for CNS disorders, collaborating with the University of Pennsylvania to enhance its gene therapy pipeline.
Passage Bio (Nasdaq: PASG) presented its 2022 outlook at the J.P. Morgan Healthcare Conference, highlighting key clinical programs and initiatives. The company plans to advance its Imagine-1 clinical trial for GM1 gangliosidosis with additional data presented at the 18th Annual WORLD Symposium on February 11, 2022. They aim to dose patients in Cohorts 2 and 3 along with initiating trials for frontotemporal dementia and Krabbe disease early in 2022. Passage Bio is also investing in a new pilot manufacturing suite to enhance operational capabilities and ensure a robust pipeline.