Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

RTTNews | 517 days ago
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 | 585 days ago
Thai Stock Market Expected To Open In The Red Again On Monday

Thai Stock Market Expected To Open In The Red Again On Monday

The Thai stock market has moved lower in consecutive trading days, falling more than 25 points or 2 percent along the way. The Stock Exchange of Thailand now sits just beneath the 1,220-point plateau and it's likely in for a rough ride again on Monday.
RTTNews | 43 minutes ago
Indonesia Bourse May Turn Lower Again On Monday

Indonesia Bourse May Turn Lower Again On Monday

The Indonesia stock market on Friday halted the two-day slide in which it had dropped almost 140 points or 1.9 percent. The Jakarta Composite Index now sits just shy of the 7,540-point plateau although it's likely to head south again on Monday.
RTTNews | 1h 13min ago
Japanese Market Sharply Lower; Down 2%

Japanese Market Sharply Lower; Down 2%

The Japanese stock market is trading sharply lower on Monday, extending the losses in the previous session, following the broadly negative cues from Wall Street on Friday, with the Nikkei 225 tumbling more than 2 percent to well below the 39,950 level, with weakness across all sectors led by exporters, automakers and financial stocks.
RTTNews | 1h 13min ago
No Help Yet For Hong Kong Stock Market

No Help Yet For Hong Kong Stock Market

The Hong Kong stock market has tracked lower in four straight sessions, dropping more than 1,050 points or 4 percent along the way. The Hang Seng Index now rests just above the 24,500-point plateau and it's expected to open in the red again on Monday.
RTTNews | 1h 28min ago
Lower Open Predicted For China Stock Market

Lower Open Predicted For China Stock Market

The China stock market has finished lower in consecutive trading days, sinking more than 55 points or 1.7 percent along the way. The Shanghai Composite Index now sits just shy of the 3,560-point plateau and the losses may accelerate on Monday.
RTTNews | 1h 43min ago