Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | Před 503 dny
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 Resubmits Arimoclomol NDA To FDA

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).
RTTNews | Před 571 dny
Sensex, Nifty Fluctuate In Early Trade

Sensex, Nifty Fluctuate In Early Trade

Indian shares were fluctuating on Monday as investors reacted to a slew of earnings, EU sanctions on Nayara refinery and comments from India's Commerce Minister Piyush Goyal that India will enter international trade agreements only if they serve the country's interests.
RTTNews | Před 13 minutami
Sensex, Nifty Set For Muted Start

Sensex, Nifty Set For Muted Start

Indian shares are seen opening little changed on Monday, with earnings and trade developments likely to be in focus.
RTTNews | Před 2 h 2 min
Asian Shares Mostly Higher In Cautious Trade

Asian Shares Mostly Higher In Cautious Trade

Asian stocks were mostly higher on Monday as trade tensions persisted, China held key lending rates and Japan's ruling coalition lost control of the upper house in an election on Sunday, further weakening Prime Minister Shigeru Ishiba's grip on power.
RTTNews | Před 2 h 18 min
Indonesia Bourse May See Profit Taking On Monday

Indonesia Bourse May See Profit Taking On Monday

The Indonesia stock market has moved higher in 10 straight sessions, gathering more than 440 points or 6.3 percent along the way. The Jakarta Composite Index now sits just above the 7,310-point plateau although it's overdue for consolidation on Monday.
RTTNews | Před 3 h 10 min
Little Movement Seen For Hong Kong Stock Market

Little Movement Seen For Hong Kong Stock Market

The Hong Kong stock market on Friday halted the two-day losing streak in which it had slipped more than 90 points or 0.3 percent. The Hang Seng Index now sits just above the 24,825-point plateau although it may be stuck in neutral on Monday.
RTTNews | Před 3 h 25 min
Little Movement Likely For China Stock Market

Little Movement Likely For China Stock Market

The China stock market has finished higher in consecutive trading days, collecting more than 30 points or 0.8 percent along the way. The Shanghai Composite Index now sits just beneath the 3,535-point plateau and it's expected to hold steady at the mark on Monday.
RTTNews | Před 3 h 40 min