- Urgency for effective treatment underscored by European Commission designation for investigational gene therapy PBKR03
- Global Phase 1/2 trial – GALax-C – PBKR03 planned to initiate in first half of 2021
PHILADELPHIA, April 05, 2021 (GLOBE NEWSWIRE) Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that the European Commission has granted Orphan designation for PBKR03, an adeno-associated virus (AAV)-delivery gene therapy for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). The designation was based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products. Currently, there are no approved disease-modifying therapies available for Krabbe disease, a rare lysosomal storage disease that most often presents early in a child’s life. The U.S. Food and Drug Administration (FDA)
Passage Bio Appoints Eliseo O Salinas, M D , MSc, as Chief Research & Development Officer
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Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Passage Bio Appoints Maxine Gowen, Ph.D. to Board of Directors
Passage BioFebruary 19, 2021 GMT
PHILADELPHIA, Feb. 19, 2021 (GLOBE NEWSWIRE) Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system (CNS) disorders, today announced the appointment of Maxine Gowen, Ph.D., to its board of directors, effective Feb. 18. Dr. Gowen is chief executive officer of Tamuro Bio, a post that she has held since July 2019.
“We are immensely excited to have Maxine join our board of directors,” said Dr. Bruce Goldsmith, president and chief executive officer of Passage Bio. “Her public company leadership and deep clinical development expertise will provide tremendous support to Passage Bio as we transition to a clinical development organization in the first half of 2021.”
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
FDA Clears IND Application for Passage Bio’s Gene Therapy Candidate PBKR03 for Treatment of .
Passage BioFebruary 8, 2021 GMT
- Phase 1/2 trial expected to commence in first half of 2021
- Company has three INDs cleared for rare monogenic CNS disorders
PHILADELPHIA, Feb. 08, 2021 (GLOBE NEWSWIRE) Passage Bio, Inc. (Nasdaq: PASG), a genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for PBKR03, an adeno-associated virus (AAV)-delivery gene therapy being studied for the treatment of early infantile Krabbe disease (Globoid Cell Leukodystrophy). Currently, there are no approved disease-modifying therapies available for Krabbe disease, a rare lysosomal storage disease that most often