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Sangamo preps FDA application for Fabry gene therapy on heels of phase 1/2 registrational data

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Sangamo Therapeutics’ investigational gene therapy appears to improve kidney function at 52 weeks for patients with a rare genetic disorder.

The biotech plans to use the data for an FDA submission next year via the agency's accelerated approval pathway.

Source
Fierce Biotech

Eli Lilly helps struggling Sangamo with $1.4B gene therapy deal

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Sangamo Therapeutics has stacked up $18 million cash from Eli Lilly in a licensing deal that will let the pharma use the biotech's neurotropic adeno-associated virus capsid in efforts to develop a gene therapy for a central nervous system disease.

Source
Fierce Biotech

Sangamo shares plunge after Pfizer ends hemophilia A gene therapy deal

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Sangamo Therapeutics said on Monday it would regain the rights to its hemophilia A gene therapy following the termination of a co-development agreement with partner Pfizer, sending its shares down 30.3% in extended trading.

Source
MSN/Reuters

Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package

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Sangamo Therapeutics has identified a shortcut to market for its Fabry disease candidate, aligning with the FDA on a pathway that could slash three years from the time to market and free it from the need to run an additional registrational study. Shares in Sangamo jumped 33% to $1.22 in the wake of the news.

Source
Fierce Biotech

Sangamo secures $50M upfront in neurodegenerative pact with Roche's Genentech

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Biogen and Novartis may have walked away from partnerships with Sangamo Therapeutics last year, but that hasn't stopped Roche from seeking out a pact with the biotech to work on intravenous genomic medicines for neurodegenerative diseases. 

Source
Fierce Biotech

Rani and Sangamo jettison staff, offices and assets to keep businesses afloat next year

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Rani Therapeutics and Sangamo Therapeutics have become the latest biotechs to significantly shrink their workforces in order to eke out cash to survive another year.

California-based Rani will lose a quarter of employees as part of a package of measures to extend its cash runway long enough to see top-line results for a phase 2 trial of a teriparatide-containing pill for osteoporosis called RT-102 alongside a phase 1 study of RT-111, a biosimilar of Johnson & Johnson’s Crohn's disease drug Stelara.

Source
Fierce Biotech

Novartis, Biogen Scrap Gene Regulation Partnerships with Sangamo

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Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued their partnerships studying gene regulation therapies in the neurology space.

Source
BioSpace

Another Pfizer gene therapy is free of FDA hold, but delay continues

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Another of Pfizer's gene therapies has been freed from an FDA clinical hold, but the study is not set to get underway immediately.


The FDA lifted its clinical hold of a phase 3 study called Affine for the hemophilia A gene therapy giroctocogene fitelparvovec in March. But Pfizer is maintaining a voluntary pause and will resume clinical activities in a few months, the company said during first quarter earnings Tuesday.

Source
Fierce Biotech

Sanofi cuts ties with Sangamo, sharpening focus on 'off-the-shelf' cell therapy

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Sanofi has ended a long-running alliance with Sangamo Therapeutics to develop genetic medicines for inherited blood disorders, among them an experimental sickle cell disease therapy that is in early clinical testing.

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BioPharma Dive