Dicerna's DCR-PHXC a Breakthrough Therapy for rare kidney disorder - 1 minute read
Dicerna's DCR-PHXC a Breakthrough Therapy for rare kidney disorder - Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA)
The FDA has designatedDicerna Pharmaceuticals' (DRNA ) RNAi candidate DCR-PHXC a Breakthrough Therapy for the treatment of a rare inherited kidney disorder called primary hyperoxaluria type 1 (PH1).
PH2 and PH3 may be added in the future.
A Phase 2 study, PHYOX2, in PH1 and PH2 is recruiting patients.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Source: Seekingalpha.com
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Keywords:
Breakthrough therapy • Rare disease • Kidney • Pharmaceutical drug • NASDAQ • Drňa • Food and Drug Administration • Pharmaceutical drug • Drňa • RNA interference • Breakthrough therapy • Chemotherapy • Rare disease • Kidney • Primary hyperoxaluria • Primary hyperoxaluria • Kepler-86 • Phases of clinical research • Breakthrough therapy • Food and Drug Administration • Marketing •
The FDA has designatedDicerna Pharmaceuticals' (DRNA ) RNAi candidate DCR-PHXC a Breakthrough Therapy for the treatment of a rare inherited kidney disorder called primary hyperoxaluria type 1 (PH1).
PH2 and PH3 may be added in the future.
A Phase 2 study, PHYOX2, in PH1 and PH2 is recruiting patients.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Source: Seekingalpha.com
Powered by NewsAPI.org
Keywords:
Breakthrough therapy • Rare disease • Kidney • Pharmaceutical drug • NASDAQ • Drňa • Food and Drug Administration • Pharmaceutical drug • Drňa • RNA interference • Breakthrough therapy • Chemotherapy • Rare disease • Kidney • Primary hyperoxaluria • Primary hyperoxaluria • Kepler-86 • Phases of clinical research • Breakthrough therapy • Food and Drug Administration • Marketing •