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

RTTNews | 1245 hari yang lalu
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.

For More Such Health News, visit rttnews.com

baca selengkapnya
Swiss Market Ends On Upbeat Note

Swiss Market Ends On Upbeat Note

After opening on a somewhat cautious note Wednesday morning, the Switzerland stock market recovered and then kept climbing higher and higher as the day progressed to eventually settle on an upbeat note. Positive global markets amid easing trade and inflation concerns rendered the mood in the Swiss market quite bullish.
RTTNews | 2 jam 48 menit yang lalu
TSX Up Sharply As Investors React To Earnings, U.S. Midterm Election Outcome

TSX Up Sharply As Investors React To Earnings, U.S. Midterm Election Outcome

The Canadian market is up firmly in positive territory Wednesday morning with the benchmark S&P/TSX Composite surging 1.7%. The mood in the market is quite positive amid hopes of easing trade tensions between Canada and the U.S., following the Democrats regaining control of both chambers of Congress in the US, defeating the Republicans in the midterm polls.
RTTNews | 4 jam 53 menit yang lalu
U.S. Services Index Edges Slightly Lower In October

U.S. Services Index Edges Slightly Lower In October

Service sector growth in the U.S. saw a modest slowdown in the month of October, according to a report released by the Institute for Supply Management on Wednesday. The ISM said its services PMI edged down to 54.5 in October after dipping to 54.9 in September, although a reading above 50 still indicates growth. Economists had expected the index to slip to 54.7.
RTTNews | 6 jam 9 menit yang lalu
U.S. Private Sector Adds 86,000 Jobs In October, More Than Expected

U.S. Private Sector Adds 86,000 Jobs In October, More Than Expected

Payroll processor ADP released a report on Wednesday showing private sector employment in the U.S. grew by more than expected in the month of October. The report said private sector employment climbed by 86,000 jobs in October, matching a downwardly revised increase in September.
RTTNews | 6 jam 43 menit yang lalu
CVS Health Swings To Q3 Profit, Lifts FY26 Outlook; To Split Into Two; Shares Drop

CVS Health Swings To Q3 Profit, Lifts FY26 Outlook; To Split Into Two; Shares Drop

CVS Health Corp. reported Wednesday a profit in its third quarter, compared to prior year's loss, mainly on the absence of prior year's $5.7 billion goodwill impairment charge, and higher revenues. Further, the firm raised fiscal 2026 outlook to reflect increases in the Health Care Benefits and Pharmacy & Consumer Wellness segments. Separately, CVS Health announced its plan to separate into two.
RTTNews | 7 jam 51 menit yang lalu