Passage Bio, Inc. Stock Price, News & Analysis

Passage Bio has secured rights to innovative technology from the University of Pennsylvania’s Gene Therapy Program aimed at mitigating dorsal root ganglia (DRG) toxicity observed in gene therapy. This collaboration could enhance the safety of its gene therapy treatments for rare CNS disorders. Although safety studies have not indicated clinical manifestations of DRG toxicity, Passage Bio expresses optimism about integrating this new approach into its programs if it proves beneficial. The company anticipates initiating clinical trials for several programs in 2021.

Passage Bio (Nasdaq: PASG), a company specializing in genetic therapies for rare CNS disorders, will participate in two virtual investor conferences in November. The Guggenheim Virtual Healthcare Talks will take place on November 16, 2020, followed by the Stifel Virtual Healthcare Conference on November 18, 2020, where Passage Bio will present at 4:00 p.m. ET. The company is committed to developing innovative gene therapies in collaboration with the University of Pennsylvania's Gene Therapy Program.

Passage Bio (NASDAQ: PASG) reported its third-quarter financial results as of September 30, 2020, showing cash equivalents of $335.7 million, up from $158.9 million in December 2019. The company is advancing three Phase 1/2 clinical trials for GM1, FTD-GRN, and Krabbe disease, with the first patient dosing for PBGM01 expected in Q1 2021 and safety data anticipated mid-2021. Additionally, PBGM01 received Orphan Drug Designation from the European Commission. R&D expenses surged to $20.8 million, while the net loss reached $28.5 million, or $0.63 per share, reflecting increased operational investments.

Passage Bio (NASDAQ: PASG) partners with Invitae to enhance genetic testing for GM1 gangliosidosis. This collaboration offers free genetic testing and counseling through Invitae’s Detect LSDs program, promoting early diagnosis and access to clinical trials. The initiative aims to support patients, especially infants, as GM1's severe form has a life expectancy of only 2-4 years. Passage Bio plans to initiate its Phase 1/2 trial for PBGM01 shortly, positioning the partnership as crucial for early intervention and treatment.

Passage Bio (NASDAQ: PASG) announced a conference call and live webcast scheduled for 8:30 a.m. ET on November 10, 2020, to discuss its Q3 2020 financial results and recent business highlights. The call can be accessed by dialing 833-528-0605 (domestic) or 830-221-9711 (international) with conference ID 8478507. The archived webcast will be available for 30 days post-event. The company focuses on gene therapies for rare CNS disorders and collaborates with the University of Pennsylvania’s Gene Therapy Program.

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.