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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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561 dni temu
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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573 dni temu
Bay Street Likely To Open On Weak Note
Canadian shares are likely to open lower on Tuesday, tracking weak European markets amid growing uncertainty over U.S. - EU trade talks. Weak crude oil and bullion prices may hurt as well.
The economic calendar is blank and there are no big earnings news as well. The mood in the market is likely to remain cautious.
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1g 30 minut temu
GM Q2 Results Down, Yet Beat Market; Backs FY25 View; Shares Hit
Automajor General Motors Co. on Tuesday maintained its fiscal 2025 earnings outlook, after reporting weak profit and revenues in its second quarter. However, adjusted earnings and top line beat market estimates. In the pre-market activity on the NYSE, General Motors shares were losing around 3.7 percent.
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2g 53 minut temu
FTSE Flat At Noon; Compass Group, Centrica Post Strong Gains
U.K. stocks are turning in a mixed performance in cautious trade on Tuesday with investors reacting to some earnings updates, and assessing the possible move of the U.S. and the European Union in the event of the ongoing trade negotiations failing to result in any meaningful solution to the tariff issues.
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2g 54 minut temu
UK Budget Deficit Exceeds Estimate In June
The UK budget deficit widened more than estimated in June on higher debt servicing costs, which has added pressure on Chancellor Rachel Reeves to raise taxes at the autumn budget. Public sector net borrowing rose by GBP 6.6 billion from the previous year to GBP 20.7 billion in June, the Office for National Statistics reported Tuesday.
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3g 0 minut temu
CAC Moderately Lower As Investors Await Progress In Trade Talks
French stocks are notably lower on Tuesday amid rising uncertainty over U.S.-EU trade talks ahead of the August 1 deadline. The mood is very cautious with investors awaiting a slew of earnings updates from big name French companies.
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3g 14 minut temu
DAX Down Nearly 1%; Sartorius Plunges 9%
German stocks are down in negative territory on Tuesday, weighed down by some weak earnings updates and uncertainty about tariffs.
The European Union is reportedly preparing to respond with a suite of retaliatory measures under its Anti-Coercion Instrument (ACI) following U.S. President Donald Trump's threat to impose a 30% tariff on EU goods from 1 August.
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3g 28 minut temu
