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498,131 Results for "sio gene therapies".
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Gene therapy
AviadoBio Looks to China for Eye-Based Gene Therapy in $413M UgeneX Pact
AviadoBio will have the option to exclusively license UGX-202, a vision-restoring gene therapy for the rare eye condition retinitis pigmentosa.
October 10, 2025
·
2 min read
·
Tristan Manalac
FDA
FDA Details Thinking for Streamlining Development of Cell, Gene, Regenerative Therapies
Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.
September 25, 2025
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2 min read
·
Tristan Manalac
Gene therapy
Capsida Reports Patient Death in Gene Therapy Trial
Capsida has yet to disclose the exact cause of death. The patient had received the gene therapy CAP-002 for a type of epilepsy.
September 11, 2025
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2 min read
·
Tristan Manalac
Cell and Gene Therapy
Meeting on the Mesa Arrives Amid Mixed Signals for Cell and Gene Therapy
As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M&A activity and regulatory support signaling momentum while commercialization challenges continue to hinder broader investor interest.
October 6, 2025
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5 min read
·
Ben Hargreaves
Gene therapy
Sarepta’s Not Done With Gene Therapy Yet as LGMD Asset Yields Promising Data
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
October 15, 2025
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6 min read
·
Tristan Manalac
Gene therapy
Doctors Still Prescribing Sarepta’s DMD Gene Therapy After Safety Concerns
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.
September 16, 2025
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3 min read
·
Annalee Armstrong
Funding
Gene Therapy Specialist Kriya Raises $313M
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
August 18, 2025
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2 min read
·
Tristan Manalac
Cell and Gene Therapy
FDA’s New Cell and Gene Therapy Guidances Finally Go a ‘Click Further’ to ‘Game Changing’
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.
October 3, 2025
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5 min read
·
Dan Samorodnitsky
Gene therapy
Regenxbio’s Hunter Syndrome Gene Therapy Hit With 3-Month PDUFA Delay
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset.
August 19, 2025
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2 min read
·
Tristan Manalac
IN PARTNERSHIP WITH TOZARO
The Future of Cell and Gene Therapy: Navigating Innovation, Regulation, and Manufacturing Challenges
An interview with Philip Vanek, chief commercialization officer of the International Society for Cell & Gene Therapy (ISCT), reveals both promising developments and significant concerns shaping the advanced therapies sector’s trajectory through 2025 and beyond. This interview was conducted with support from
Tozaro
.
August 11, 2025
·
8 min read
·
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