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Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol
(RTTNews) - Zevra Therapeutics, Inc. (ZVRA) announced Monday the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC).
In addition, the FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of September 21, 2024, and has re-affirmed its intent to present the resubmission for discussion at an advisory committee meeting to be scheduled.
As part of the ongoing review, Zevra received notification from the FDA that it required more time to review the additional analyses provided by the Company in responses to recent information requests generated from the FDA's review.
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Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C
Rare disease therapeutics company Zevra Therapeutics, Inc. (ZVRA) announced Monday that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.
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Zevra Therapeutics Resubmits Arimoclomol NDA To FDA
Zevra Therapeutics, Inc. (ZVRA) announced Wednesday it resubmitted its New Drug Application (NDA) for arimoclomol to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Arimoclomol is an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC).
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Honeywell Lifts FY25 Outlook Above Markt After Q2 Beats Street
Honeywell International Inc. (HON), which is preparing to separate into three public companies, on Thursday lifted its fiscal 2025 outlook for earnings and revenues after reporting higher second-quarter results above market estimates.
In pre-market activity on the Nasdaq, Honeywell shares were losing around 1.4 percent.
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FTSE 100 Up Nearly 1% On Encouraging Earnings Updates
U.K. stocks are up firmly in positive territory Thursday morning amid easing concerns about trade, as the U.S. and EU appear set to strike a deal sometime soon. Investors are also reacting to earnings updates and the latest batch of regional economic data.
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Sensex Drops 542 Points On Trade Deal Uncertainty; Nifty Dips Below 25,100
Indian shares fell notably on Thursday as investors fretted over stalled India-U.S. trade deal, slowing earnings growth and recent selling by foreign portfolio investors.
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Deutsche Bank Shares Up On Highest Q2 Profit Since 2007; Maintains FY25 Guidance
Shares of Deutsche Bank AG were gaining around 7 percent in the morning trading in Germany and around 6 percent in the pre-market activity on the NYSE, after the banking major reported Thursday a net profit in its second quarter, compared to prior year's loss, mainly on the non-recurrence of a litigation provision, and higher revenues.
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German Consumer Sentiment To Weaken In August: GfK
Consumer confidence in Germany is set to deteriorate in August as households preferred to save rather than spend due to the escalating uncertainty, survey data from the market research group GfK revealed on Thursday. The Consumer Climate indicator dropped unexpectedly to -21.5 points in August from -20.3 points in July. The score was forecast to improve to -19.4.
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CAC Flat In Cautious Trade As Investors Focus On Earnings
French stocks are turning in a mixed performance on Thursday with investors making cautious moves despite growing optimism the U.S. and EU will arrive at a trade agreement soon.
Investors are digesting corporate earnings updates, and await the European Central Bank's monetary policy announcement due later in the day.
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