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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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Swiss Market Ends Modestly Lower
The Switzerland market stayed a bit positive in early trades on Thursday, but retreated around mid morning and then spent the rest of the day's session in negative territory, as investors stayed largely cautious, reacting to earnings and awaiting news from the trade front.
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European Stocks Close Broadly Higher
European stocks closed broadly higher on Thursday despite paring most of their early gains, after the European Central Bank left its interest rate unchanged for the first time in a year.
The ECB held its key interest rates steady, in line with expectations.
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U.S. New Home Sales Rebound Much Less Than Expected In June
After reporting a steep drop by new home sales in the U.S. in the previous month, the Commerce Department released a report on Thursday showing a modest rebound by new home sales in the month of June. The Commerce Department said new home sales rose by 0.6 percent to an annual rate of 627,000 in June after plummeting by 11.6 percent to a rate of 623,000 in May.
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U.S. Initial Jobless Claims Unexpectedly Dip To 217,000
The Labor Department released a report on Thursday unexpectedly showing another modest decrease by first-time claims for U.S. unemployment benefits in the week ended July 19th. The report said initial jobless claims edged down to 217,000, a decrease of 4,000 from the previous week's unrevised level of 221,000. Economists had expected jobless claims to rise to 227,000.
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ECB Leaves Rates Unchanged As Expected
The European Central Bank held its key interest rates steady on Thursday, in line with expectations, as policymakers assessed that price pressures continue to ease, but acknowledged that the economic environment remains highly uncertain mainly due to the trade tariff wars.
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UK Private Sector Growth Moderates On Services Activity
UK private sector output continued to grow in July but the pace of expansion moderated as services activity lost momentum, flash survey results from S&P Global revealed on Thursday. The composite output index slid to 51.0 in July from 52.0 in June. The reading was also above the forecast of 51.9.
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