Lexeo Therapeutics Says FDA Grants Fast Track And Orphan Drug Designation To LX2020

RTTNews | 641 gün önce
Lexeo Therapeutics Says FDA Grants Fast Track And Orphan Drug Designation To LX2020

(RTTNews) - Genetic medicine company Lexeo Therapeutics, Inc. (LXEO) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Orphan Drug designation to LX2020.

LX2020 is the company's AAVrh10-based gene therapy candidate designed to intravenously deliver a functional PKP2 gene to cardiac muscle for the treatment of arrhythmogenic cardiomyopathy (ACM) caused by mutations in the PKP2 gene (PKP2-ACM).

The planned Phase 1/2 trial, HEROIC-PKP2, is a first in human, 52-week open-label, dose-escalating, multicenter trial to determine the safety and tolerability of LX2020 in adult patients with PKP2-ACM.

Preliminary efficacy measures will evaluate myocardial protein expression, biomarkers measuring cardiac structure and function, and arrhythmia burden.

LX2020 will be administered as a one-time intravenous infusion to patients in two ascending-dose cohorts, evaluating the 2.0x1013 vg/kg and 6.0x1013 vg/kg dose levels with three patients in each cohort, and the potential for cohort expansion.

Long-term safety and efficacy will be evaluated for an additional four years following completion of the initial trial.

Etiketler: LXEO
read more
Swiss Market Ends Higher For 2nd Straight Session

Swiss Market Ends Higher For 2nd Straight Session

The Switzerland market opened on a slightly weak note on Friday, but recovered swiftly and then kept edging higher to eventually end the day's session on a firm note.
RTTNews | 3s 34 dakika önce
Major European Markets Close Slightly Weak

Major European Markets Close Slightly Weak

The major European markets closed slightly down on Friday as investors assessed recent moves of the central banks and weighed the potential impact of tariffs. A bit of profit taking also contributed to the market's weak close.
RTTNews | 3s 59 dakika önce
TSX Marches On, Hits Fresh Record High; Materials Stocks Rally

TSX Marches On, Hits Fresh Record High; Materials Stocks Rally

The Canadian market is up firmly in positive territory a little past noon on Friday, extending recent gains, thanks largely to strong buying in the materials sector. Energy stocks are struggling for support due to weak oil prices. The mood remains fairly bullish amid expectations the Bank of Canada and the Federal Reserve will announce further easing this year to boost growth.
RTTNews | 5s 5 dakika önce
Bank Of Japan Holds Rate Steady; Plans To Lower ETF Holdings

Bank Of Japan Holds Rate Steady; Plans To Lower ETF Holdings

The Japanese central bank left its key interest rate unchanged on Friday, as expected, but surprised markets with a decision to reduce the holdings of its massive stock of exchange-traded funds, suggesting that the monetary policy normalization is underway. The Bank of Japan policy board, led by Governor Kazuo Ueda, voted 7-2 to hold the uncollateralized overnight call rate at around 0.5 percen
RTTNews | 8s 0 dakika önce
Bay Street Likely To Open On Subdued Note

Bay Street Likely To Open On Subdued Note

Canadian shares may open on a somewhat subdued note on Friday with investors reacting to retail sales data, and looking to take some profits following recent gains.
RTTNews | 8s 45 dakika önce
Pound Slides As UK Bond Yield Soars

Pound Slides As UK Bond Yield Soars

The British pound weakened against other major currencies in the European session on Friday, as long-dated UK bond yields rise sharply in response to increasing public sector borrowings in August.
RTTNews | 10s 29 dakika önce