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518,113 Results for "sio gene therapies".
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Neuroscience
UniQure’s chronic epilepsy gene therapy ‘should be on investors’ radar’
As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a “promising start.”
June 22, 2026
·
3 min read
·
Tristan Manalac
Duchenne muscular dystrophy
REGENXBIO bets on FDA flexibility with filing plans for Duchenne gene therapy
A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
June 24, 2026
·
2 min read
·
Gabrielle Masson
Editorial
BIO 2026: Cell and gene therapy sector must break the mold to thrive
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
June 22, 2026
·
4 min read
·
Jef Akst
Opinion
The next FDA commissioner must be a champion for gene therapies
The FDA must provide consistent and predictable regulatory frameworks if the U.S. is to maintain its leadership in gene therapy, one of the most consequential therapeutic fields of our generation.
June 5, 2026
·
4 min read
·
Erik Paulsen
Gene therapy
4 spaces primed for the next wave of gene therapies
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here,
BioSpace
reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
May 18, 2026
·
8 min read
·
Andrea Park
FDA
REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot
The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
June 22, 2026
·
3 min read
·
Heather McKenzie
Opinion
Gene therapy’s evidence problem—lessons from recent FDA decisions
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.
May 4, 2026
·
6 min read
·
Jenna DiRito
Funding
Rejuvenate crowdfunds development of gene therapy for aging, chronic diseases
George Church’s Rejuvenate Bio is turning to social networks to help fund its work on one-time gene therapies targeting chronic diseases and root causes of aging.
April 27, 2026
·
2 min read
·
Tristan Manalac
gene editing
Gene therapy leaders aim to help more Baby KJs with novel regulatory models
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
April 27, 2026
·
5 min read
·
Heather McKenzie
Gene therapy
FDA approval of Regeneron’s hearing loss gene therapy breaks barriers
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
April 23, 2026
·
4 min read
·
Heather McKenzie
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