QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug [Yahoo! Finance]
Alnylam Pharmaceuticals, Inc. (ALNY)
Last alnylam pharmaceuticals, inc. earnings: 2/6 08:00 am
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Source: Yahoo! Finance
one-time administered investigational gene therapy, which is being developed to treat Huntington's disease. Huntington's disease is a genetic disorder that causes the progressive breakdown of nerve cells in the brain, which leads to a decline in cognitive and physical abilities, often resulting in movement, thinking and psychiatric problems. uniQure enjoys the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for AMT-130 to treat Huntington's disease. The alignment with the FDA was reached at an RMAT meeting with the regulatory body in November 2024. The FDA agreed that the reported data from the ongoing early to mid-stage studies of AMT-130 for Huntington's disease compared with a natural history external control are sufficient to serve as the primary basis for a regulatory filing under the expedited pathway, avoiding the need for an additional pre-submission study. Furthermore, the regulatory body has also agreed that cUHDRS may be used as an intermediate clinica
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ALNY
Earnings
- 10/31/24 - Beat
ALNY
Sec Filings
- 12/13/24 - Form 4
- 12/12/24 - Form 144
- 11/27/24 - Form 4
- ALNY's page on the SEC website