Rocket Pharma Says FDA Grants Fast Track And Orphan Drug Designations For RP-A601 Gene Therapy

RTTNews | vor 710 Tagen
Rocket Pharma Says FDA Grants Fast Track And Orphan Drug Designations For RP-A601 Gene Therapy

(RTTNews) - Biotechnology company Rocket Pharmaceuticals, Inc. (RCKT) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to RP-A601, the Company's gene therapy candidate for the treatment of plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM).

RP-A601 is Rocket's adeno-associated virus (AAV.rh74)-based gene therapy for PKP2-ACM, a devastating, inherited heart disease associated with life-threatening arrhythmias, cardiac structural abnormalities, and sudden cardiac death.

Rocket recently announced FDA clearance of the Investigational New Drug (IND) application for RP-A601 based on robust preclinical proof of concept studies that demonstrated decreased arrhythmias and increased survival.

The Company is initiating a multi-center Phase 1, dose escalation trial that will evaluate the safety and preliminary efficacy of RP-A601 in at least six adult PKP2-ACM patients with ICDs and who have overall high risk for life-threatening arrhythmias.

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Fijian Import & Export Recalls Ready-To-Eat Meat Pie Products

Fijian Import & Export Recalls Ready-To-Eat Meat Pie Products

Hayward, California-based Fijian Import & Export Co. Inc. is recalling around 127 pounds of ready-to-eat meat pie products from Australia that were not presented for import reinspection upon entry into the United States, according to the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS. The recall involves 5.6-oz. plastic packages...
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Australian Market Halves Early Losses In Mid-market

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RTTNews | vor 2Std 12 Minuten
Asian Markets Trade Mostly Lower

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RTTNews | vor 2Std 29 Minuten
Sensex, Nifty Seen Lower On US Debt Concerns

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Thai Bourse May Reclaim 1,200-Point Plateau

Thai Bourse May Reclaim 1,200-Point Plateau

The Thai stock market has alternated between positive and negative finishes through the last eight trading days since the end of the five-day winning streak in which it had advanced more than 50 points or 4.3 percent. The Stock Exchange of Thailand now sits just above the 1,195-point plateau and it's expected to open to the upside again on Monday.
RTTNews | vor 3Std 41 Minuten