Passage Bio, Inc. Stock Price, News & Analysis

Passage Bio (NASDAQ: PASG) reported a net loss of $38.9 million for Q1 2021, with cash and equivalents at $437.6 million after a $166 million public offering. The company initiated its Phase 1/2 Imagine-1 trial for PBGM01, focused on infantile GM1 gangliosidosis, and expects the first patient for the FTD-GRN trial by 2Q/3Q 2021. Regulatory approvals were obtained for three advanced pipeline programs, including PBFT02 and PBKR03. Despite COVID-19-related delays, Passage Bio aims to reveal initial safety and biomarker data for its trials in 4Q21 and 1H22.

Passage Bio (NASDAQ: PASG) announced a collaboration with InformedDNA to offer no-cost genetic counseling and testing for adults diagnosed with Frontotemporal Dementia (FTD). The initiative aims to identify patients with inherited genetic mutations, facilitating early treatment and clinical trial recruitment. FTD affects 50,000–60,000 Americans and is a leading cause of dementia under age 65. Additionally, Passage Bio is developing PBFT02, a gene therapy for FTD with granulin mutations, which is slated for a Phase 1/2 clinical study.

Passage Bio (NASDAQ: PASG) is set to announce its Q1 2021 financial results on May 5, 2021, during a conference call at 8:30 a.m. ET. The call will provide updates on recent business highlights in genetic medicines focused on rare CNS disorders. Interested parties can join the call by dialing 833-528-0605 (domestic) or 830-221-9111 (international). A live audio webcast will also be available on the company's investors page.

The company is partnered with the University of Pennsylvania for gene therapy innovations.

Passage Bio announced that the European Commission granted Orphan designation for its investigational gene therapy PBKR03, aimed at treating Krabbe disease, which currently has no approved therapies. The therapy, utilizing a proprietary AAV delivery method, is expected to begin a global Phase 1/2 trial, GALax-C, in the first half of 2021. This designation, along with previous FDA recognitions, emphasizes the urgency for effective treatments for this severe disease. Preclinical data indicate significant potential in improving myelination and clinical outcomes.

Passage Bio has progressed its PBGM01 gene therapy into clinical development, marking a significant milestone for the company. The first patient was dosed in the global Phase 1/2 Imagine-1 trial to treat infantile GM1 gangliosidosis, which affects approximately 0.5 to 1 in 100,000 live births. The trial aims to assess the safety, tolerability, and efficacy of PBGM01. Passage Bio anticipates releasing initial safety and biomarker data in mid-2021, with plans to open 10 clinical sites globally, enhancing its research capacity.

Passage Bio, a genetic medicines company focused on therapies for rare CNS disorders, announces participation in three virtual investor conferences. The events are scheduled for April 1, 13, and 26, 2021. The company aims to showcase its advancements in gene therapies and engage with investors. Webcasts of the events will be available on the company’s website, with replays for 30 days. Passage Bio collaborates with the University of Pennsylvania’s Gene Therapy Program to expedite its pipeline development. For more information, visit passagebio.com.

Passage Bio (Nasdaq: PASG) has appointed Eliseo O. Salinas, M.D., MSc, as its new chief research & development officer. Previously with Acadia Pharmaceuticals, Salinas brings over 30 years of experience in R&D leadership and expertise in neuroscience and rare diseases. His appointment aims to strengthen Passage Bio's pipeline and support its transition to a clinical-stage company with multiple assets. Salinas is expected to enhance the R&D team's capabilities to advance innovative gene therapies targeting rare CNS disorders, in collaboration with the University of Pennsylvania's Gene Therapy Program.

Passage Bio has received FDA Fast Track designation for its lead gene therapy candidates: PBGM01 for GM1 gangliosidosis, PBFT02 for frontotemporal dementia with granulin mutations, and PBKR03 for Krabbe disease. This designation will expedite their development and review processes. Clinical trials for PBGM01 will initiate in Q1 2021, followed by PBFT02 and PBKR03 in H1 2021. The company aims to meet urgent treatment needs for rare neurological diseases and has also secured various designations from regulatory agencies.

Passage Bio (NASDAQ: PASG) is advancing its clinical programs for rare CNS disorders, with three Phase 1/2 trials set to begin in H1 2021. The company has initiated patient recruitment for its PBGM01 trial for GM1 gangliosidosis and has cleared regulatory hurdles for PBKR03 (Krabbe disease) and PBFT02 (frontotemporal dementia). Following a public offering, the company strengthened its finances, raising $166M. As of December 31, 2020, cash reserves stood at $304.8M. Despite a net loss of $112.2M for 2020, Passage Bio is poised for development milestones and expanding its pipeline.