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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 (Nasdaq: PASG) announced the dosing of the first patient in its Phase 1/2 upliFT-D clinical trial for PBFT02, a gene therapy for frontotemporal dementia (FTD) with granulin mutations. This milestone is significant for advancing PBFT02, which aims to address the unmet need for effective treatments in FTD with no approved disease-modifying therapies. The trial evaluates the safety and tolerability of a single AAV-delivered dose of PBFT02. The U.S. FDA has granted Fast Track and Orphan Drug designations for this innovative therapy.
Passage Bio, a clinical-stage genetic medicines company, will have CFO Simona King participate in a virtual panel at the 2022 Wedbush PacGrow Healthcare Conference on August 9, 2022, at 8:35 a.m. ET. The panel discussion, titled "Headspace - Updates in CNS Gene Therapy," will focus on advances in gene therapy for central nervous system disorders. A live webcast will be available on their website and a replay will be accessible for 30 days post-event. Passage Bio is dedicated to developing therapies for CNS diseases with limited treatment options, and is advancing three clinical programs in notable disorders.
Passage Bio (NASDAQ: PASG) has advanced its Imagine-1 clinical trial for GM1 gangliosidosis, now in the final cohort, following Independent Data Monitoring Committee recommendations. The company presented promising long-term clinical data at ASGCT and received IND clearance for PBML04 for metachromatic leukodystrophy. As of June 30, 2022, cash reserves were $239.3 million, sufficient to fund operations into Q2 2024. The company reported a net loss of $39.5 million for Q2 2022, an improvement from $48.4 million the previous year.
Passage Bio (NASDAQ: PASG) will host a conference call on August 4, 2022, at 8:30 a.m. ET to discuss its Q2 2022 financial results and business updates. The call aims to provide insights into the company's advancements in developing gene therapies for central nervous system (CNS) disorders, including GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia. Passage Bio has established collaborations with the University of Pennsylvania's Gene Therapy Program to enhance its clinical pipeline. An archived webcast will be available following the event.
Passage Bio (Nasdaq: PASG) announced on July 21, 2022, the granting of inducement awards to new employees, including options to purchase 85,500 shares of common stock at an exercise price of $2.16 per share. These stock options will vest over four years, with 25% vesting after one year and the remainder in 36 monthly installments, contingent on continued employment. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract talent in the clinical-stage genetic medicines sector, particularly focused on CNS disorders.
Passage Bio (Nasdaq: PASG) announced the appointment of Dr. Michael Kamarck to its board of directors and the Nominating and Corporate Governance Committee. Dr. Kamarck brings over 40 years of experience in biopharmaceuticals, including leadership roles in manufacturing and technical operations. His previous positions include Chief Technology Officer at Vir Biotechnology and Senior Vice President at Merck. The company is focused on developing genetic therapies for CNS disorders and has established a collaboration with the University of Pennsylvania. Dr. Kamarck's expertise is expected to enhance Passage Bio's clinical programs.
Passage Bio (NASDAQ: PASG), a clinical-stage genetic medicines company, announced that CFO Simona King will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference from June 13-16, 2022. The event, scheduled for June 16 at 8:40 a.m. PT (11:40 a.m. ET), will be webcast live on the company’s website. Passage Bio focuses on developing transformative therapies for central nervous system disorders and is advancing clinical programs for conditions like GM1 gangliosidosis and Krabbe disease.
Passage Bio (Nasdaq: PASG) announced FDA clearance for its IND application for PBML04, a gene therapy targeting Metachromatic Leukodystrophy (MLD), a rare and fatal pediatric condition. This marks the company’s fourth IND clearance and the third pediatric lysosomal storage disorder to enter clinical development. MLD affects 1 in 100,000 live births and is caused by mutations in the ARSA gene. The Phase 1 trial will utilize ICM administration of an AAVhu68 capsid to express ARSA, offering potential treatment for MLD's severe symptoms.
Passage Bio (Nasdaq: PASG) announced the departure of Bruce Goldsmith, Ph.D., as president and CEO, effective immediately, with Edgar B. (Chip) Cale stepping in as interim CEO. Cale, the current general counsel, will lead the company while a search for a permanent CEO is underway. Over the past two years, Goldsmith oversaw significant achievements, including successful public offerings and advancing three clinical development programs. The board expressed gratitude for his contributions, emphasizing continuity in leadership during this transition.
Passage Bio, a clinical-stage genetic medicines company, has granted inducement awards to new employees, consisting of options to purchase 79,600 shares of common stock at an exercise price of $1.69 per share. This price reflects the stock's closing value on May 16, 2022. The options will vest over four years, with 25% vesting after one year. Passage Bio's focus is on developing therapies for central nervous system disorders, with ongoing clinical programs in GM1 gangliosidosis, Krabbe disease, and frontotemporal dementia.
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