Welcome to our dedicated page for Passage Bio news (Ticker: PASG), a resource for investors and traders seeking the latest updates and insights on Passage Bio stock.
Passage Bio, Inc. (NASDAQ: PASG) is a clinical stage genetic medicines company whose news flow centers on the development of its lead gene therapy candidate, PBFT02, for neurodegenerative diseases. Company updates frequently highlight progress in the Phase 1/2 upliFT-D trial in frontotemporal dementia with GRN or C9orf72 mutations, including cohort enrollment, dosing milestones, and interim biomarker and safety data.
Investors following PASG news can expect regular announcements of quarterly and annual financial results, where Passage Bio reports research and development spending, general and administrative expenses, net loss, and cash, cash equivalents, and marketable securities, along with commentary on expected cash runway. These releases often include recent business highlights related to PBFT02, such as data readouts on cerebrospinal fluid progranulin levels, plasma neurofilament light chain trends, and protocol amendments intended to refine the benefit–risk profile of the program.
News items also cover regulatory and manufacturing developments, including interactions with the U.S. Food and Drug Administration on analytical comparability for a high-productivity, suspension-based PBFT02 manufacturing process, and plans to seek feedback on potential registrational trial designs. In addition, Passage Bio regularly announces participation in healthcare, genetic medicines, and biopharma investor conferences, where management presents corporate overviews and program updates.
This page aggregates these disclosures, offering a centralized view of Passage Bio’s clinical, regulatory, financial, and corporate communications. Readers interested in PASG can use this news feed to track the evolution of the PBFT02 program, changes in trial design, manufacturing strategy, and key financial and listing-related events such as the company’s reverse stock split and subsequent confirmation of compliance with Nasdaq listing requirements.
Passage Bio (NASDAQ: PASG) announced that the FDA has granted Orphan Drug and Rare Pediatric Disease designations to PBKR03 for treating Krabbe disease. This designation highlights the urgent need for treatments in this area, as Krabbe disease currently has no approved therapies. The company aims to start a Phase 1/2 clinical trial for PBKR03 in the first half of 2021. In addition to potential market exclusivity and assistance from the FDA, the RPD designation could provide a priority review voucher for future applications.
Passage Bio (NASDAQ: PASG) announced that the European Commission granted orphan drug designation for PBGM01, its lead gene therapy for GM1 gangliosidosis, a rare CNS disorder. Previously, PBGM01 received similar designations from the FDA. This designation allows Passage Bio to gain 10-year market exclusivity upon marketing approval and provides regulatory support. The company plans to initiate a Phase 1/2 trial by early 2021, assessing safety and biomarker data by mid-2021. GM1 is severe, particularly in infants, leading to rapid neurodegeneration and limited life expectancy.
Passage Bio announced positive preclinical results for its gene therapy PBGM01, aimed at treating GM1 gangliosidosis, a severe genetic disorder affecting infants. The study from the University of Pennsylvania demonstrated that a single injection of an optimized adeno-associated virus (AAV) improved β-galactosidase activity in the brain, reduced harmful lysosomal storage lesions, and enhanced survival rates in treated mice. The company anticipates starting a Phase 1/2 clinical trial late in 2020 or early 2021, aiming to address the critical need for disease-modifying therapies for GM1.
Passage Bio (NASDAQ: PASG), a genetic medicines company, will participate in the virtual 2020 Cell & Gene Meeting on the Mesa from October 12-16, 2020. COO Jill M. Quigley will provide an overview of the company during the conference's presentations segment. CTO Alex Fotopoulos will join a panel discussion on biotherapeutics development. This event features over 120 presentations and 20 sessions on cell and gene therapy advancements. More details can be found at www.meetingonthemesa.com.
Passage Bio (NASDAQ: PASG) announced participation in two virtual investor conferences on September 25, 2020. The first is the Jefferies 2020 Virtual Gene Therapy/Editing Summit, set for October 2, 2020, at 11 a.m. ET. The second is the Chardan 4th Annual Genetic Medicines Conference, scheduled for October 5, 2020, at 1 p.m. ET. Live webcasts will be available on Passage Bio's website, with replays for 30 days post-event. The company focuses on developing therapies for rare, monogenic CNS disorders and has a portfolio of six product candidates.
Data from a study conducted by the University of Pennsylvania demonstrates that Passage Bio's gene therapy, PBFT02, significantly reverses the pathology of frontotemporal dementia caused by granulin mutations. The study, published in Annals of Clinical and Translational Neurology, shows a single injection of an AAV-GRN vector notably increases progranulin levels in the CSF, with PBFT02 achieving over 50-fold higher levels. The therapy is well tolerated, and the company plans to initiate a Phase 1/2 trial in 2021 to further investigate its efficacy for patients with GRN-related dementia.
Passage Bio (Nasdaq: PASG) reported its Q2 2020 financial results with a strong cash position of $353 million, expected to fund operations into 2023. The company is currently on clinical hold from the FDA for its PBGM01 Phase 1/2 trial due to additional device review, aiming to dose the first patient by early 2021. R&D expenses rose to $19.9 million compared to $6.3 million in Q2 2019, and the net loss increased to $27.2 million from $13.4 million. The company anticipates initial safety data in 1H2021 and continues to progress in expanding its gene therapy collaborations.
Passage Bio (NASDAQ: PASG) announced a conference call on August 13, 2020, to discuss its second quarter 2020 financial results and recent business developments. The call will start at 8:30 a.m. ET, with participation details provided for domestic and international callers. The company focuses on genetic therapies for rare central nervous system disorders, collaborating with the University of Pennsylvania for research and development. Passage Bio currently has a portfolio of six product candidates addressing conditions such as GM1 gangliosidosis and Krabbe disease.
Passage Bio has officially been added to the Russell 2000® Index as of market close on June 26, 2020. This index tracks small-cap stocks in the U.S. equity market, reflecting about 10% of the Russell 3000® Index’s market capitalization. Passage Bio specializes in genetic medicines for rare, monogenic CNS disorders, and partners with the University of Pennsylvania for research and development. Its portfolio includes six product candidates targeting GM1 gangliosidosis, frontotemporal dementia, and Krabbe disease.
Passage Bio (NASDAQ: PASG) announced participation in the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 11:20am ET. The event will be a fireside chat, and a live audio webcast can be accessed through the company's website. A replay will be available for 30 days post-event. Passage Bio focuses on developing therapies for rare, monogenic central nervous system disorders and has a collaboration with the University of Pennsylvania. Their portfolio includes six product candidates targeting conditions like GM1 gangliosidosis and Krabbe disease.