FDA Grants Passage Bio Orphan Drug Designation for PBGM01 for Treatment of Infantile GM1 Gangliosidosis
Passage Bio, Inc. (PASG)
Company Research
Source: GlobeNewswire
PHILADELPHIA, April 21, 2020 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead product candidate, PBGM01, for the treatment of infantile GM1 gangliosidosis (GM1). GM1 is a rare and often life-threatening monogenic recessive lysosomal storage disease caused by mutations in the GLB1 gene that results in rapidly progressing neurodegeneration. “Infantile GM1 is an incredibly devastating disease that impacts one of our most vulnerable populations,” said Bruce Goldsmith, Ph.D, chief executive officer of Passage Bio. “This designation represents an important recognition of the dire need for an effective treatment option for the children and their families impacted by GM1. We believe PBGM01 has the potential to be life-altering, and we look forward
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PASG
Earnings
- 3/4/24 - Beat
PASG
Analyst Actions
- 3/5/24 - Canaccord Genuity
PASG
Sec Filings
- 4/17/24 - Form EFFECT
- 4/12/24 - Form SC
- 4/9/24 - Form DEFA14A
- PASG's page on the SEC website