Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | 505天前
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 | 573天前
Japanese Market Sharply Higher; Up 1000 Points

Japanese Market Sharply Higher; Up 1000 Points

The Japanese stock market is sharply higher on Wednesday, reversing the losses in the previous two sessions, following the mixed cues from Wall Street overnight. The Nikkei 225 is surging more than 1000 points to above the 40,800 level, with gains across all sectors led by exporters, automakers and financial stocks.
RTTNews | 13分鐘前
Indonesia Bourse May Spin Its Wheels Again On Wednesday

Indonesia Bourse May Spin Its Wheels Again On Wednesday

The Indonesia stock market on Tuesday halted the 11-day winning streak in which it had surged more than 530 points or 7.5 percent. The Jakarta Composite Index now sits just beneath the 7,350-point plateau and it may remain stuck in neutral again on Wednesday.
RTTNews | 16分鐘前
Hong Kong Stocks May Run Out Of Steam On Wednesday

Hong Kong Stocks May Run Out Of Steam On Wednesday

The Hong Kong stock market has moved higher in three straight sessions, gathering almost 750 points or 3 percent in that span. The Hang Seng Index now sits just above the 25,130-point plateau although it may be stuck in neutral on Wednesday.
RTTNews | 31分鐘前
Australian Market Notably Higher

Australian Market Notably Higher

Australian shares are trading notably higher on Wednesday, extending the slight gains in the previous session, with the benchmark S&P/ASX 200 moving above the 8,700 level, following the mixed cues from Wall Street overnight, with gains across most sectors led by mining and energy stocks.
RTTNews | 32分鐘前
Profit Taking Expected For China Stock Market

Profit Taking Expected For China Stock Market

The China stock market has finished higher in four straight sessions, collecting more than 75 points or 2.1 percent along the way. The Shanghai Composite Index now sits just above the 3,580-point plateau although it may be stuck in neutral on Wednesday.
RTTNews | 46分鐘前
Taiwan Shares Expected To Find Traction On Wednesday

Taiwan Shares Expected To Find Traction On Wednesday

The Taiwan stock market has tracked lower in two straight sessions, tumbling almost 400 points or 1.8 percent along the way. The Taiwan Stock Exchange now sits just beneath the 23,000-point plateau although it's due for support on Wednesday.
RTTNews | 1小時16分鐘前