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

RTTNews | vor 591 Tagen
Stocktwits
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.

Tags: LXEO
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Bank Of Japan Keeps Rate On Hold; Lifts Inflation Forecast On Rising Food Prices

Bank Of Japan Keeps Rate On Hold; Lifts Inflation Forecast On Rising Food Prices

The Bank of Japan maintained its interest rate but lifted its inflation outlook due to rising food prices, which had added expectations of an rate hike as soon as in October. The policy board unanimously decided to hold the uncollateralized overnight call rate to remain at around 0.5 percent.
RTTNews | vor 30 Minuten
Yen Rises After BoJ Rate Decision

Yen Rises After BoJ Rate Decision

The Japanese yen strengthened against other major currencies in the Asian session on Thursday, following the Bank of Japan's decision to increase its inflation forecast for the fiscal year while maintaining steady interest rates.
RTTNews | vor 43 Minuten
Yen Rises Against Majors

Yen Rises Against Majors

The Japanese yen strengthened against other major currencies in the Asian session on Thursday.
RTTNews | vor 1Std 8 Minuten
European Economic News Preview: German Inflation, Unemployment Data Due

European Economic News Preview: German Inflation, Unemployment Data Due

Flash inflation and unemployment from Germany are due on Thursday, headlining a busy day for the European economic news. At 2.00 am ET, Destatis releases Germany's ILO unemployment data and import price figures. Import prices are forecast to fall 1.6 percent on a yearly basis in June, following a 1.1 percent drop in May.
RTTNews | vor 3Std 9 Minuten
Australian Market Trims Early Losses In Mid-market

Australian Market Trims Early Losses In Mid-market

The Australian market is trimming early losses in mid-market moves on Thursday, reversing some of the gains in the previous three sessions, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling below the 8,750 level, with weakness cross most sectors led by mining and energy stocks.
RTTNews | vor 4Std 33 Minuten
Asian Markets Mostly Lower On Tariff Worries

Asian Markets Mostly Lower On Tariff Worries

Asian stock markets are trading mostly lower on Thursday, following the mixed cues from Wall Street overnight, as traders remain cautious ahead of the final deadline of August 1 set by the US President Donald Trump for reaching trade deals with its trading partner countries. Trump hinted at higher tariffs on certain countries after the deadline. Asian markets closed mixed on Wednesday.
RTTNews | vor 4Std 58 Minuten
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