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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 (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.
Passage Bio (Nasdaq: PASG), a clinical-stage genetic medicines company, announced that CEO Bruce Goldsmith, Ph.D., will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 10:30 a.m. ET. The event will be held virtually, and a live webcast will be accessible on the company’s website, with a replay available for 30 days post-event. Passage Bio focuses on transformative therapies for central nervous system disorders and collaborates with the University of Pennsylvania’s Gene Therapy Program to enhance its gene therapy pipeline.
Passage Bio (Nasdaq: PASG) disclosed that the Independent Data Monitoring Committee recommends advancing to additional cohorts in the Imagine-1 clinical study, targeting pediatric patients with GM1 Gangliosidosis. The Phase 1/2 study demonstrated a positive safety profile with no serious adverse events, while beta-galactosidase enzyme activity significantly increased in cerebrospinal fluid and serum. Cohorts 2 and 3 are now being recruited following encouraging interim data. Results will be presented at the 18th Annual WORLD Symposium on February 11, 2022.
Passage Bio, Inc. (Nasdaq: PASG) has exercised two additional options with the University of Pennsylvania's Gene Therapy Program, focusing on Huntington's and Canavan diseases. The company plans to report initial safety and biomarker data from its Phase 1/2 trial for PBGM01 by year-end 2021 and expects to begin dosing patients for trials targeting frontotemporal dementia and Krabbe disease in early 2022. The strategic partnership enhances Passage Bio's pipeline, now including three clinical-stage assets and six additional programs, aimed at addressing significant unmet needs in CNS disorders.
Passage Bio (Nasdaq: PASG) announced the granting of an inducement stock option to a new employee, comprising 130,000 shares at an exercise price of $8.50, equal to the stock's closing price on November 15, 2021. The option will vest over four years with the first 25% vesting after one year, followed by monthly installments. This move aligns with Nasdaq Listing Rule 5635(c)(4) and reflects the company's strategy to attract talent while advancing its mission in developing genetic therapies for CNS disorders.
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