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Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C

RTTNews | 667 dagar sedan

Zevra Therapeutics Says FDA Accepts Resubmission Of Arimoclomol NDA In Niemann-Pick Disease Type C

(RTTNews) - 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.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has deemed the arimoclomol NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission.

As a result, the FDA has assigned a PDUFA action date of June 21, 2024, and currently intends to present the resubmission for discussion in an advisory committee.

Zevra believes that its resubmission of the arimoclomol NDA addresses the concerns previously raised in the June 2021 complete response letter (CRL) issued by the FDA in response to the prior arimoclomol NDA filing.

Taggar: ZVRA

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Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

Zevra Therapeutics Says FDA Extends NDA Review Period For Arimoclomol

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).

RTTNews | 611 dagar sedan

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 | 679 dagar sedan

Taiwan Bourse Due For Support On Thursday

Taiwan Bourse Due For Support On Thursday

The Taiwan stock market has finished lower in back-to-back sessions, stumbling more than 640 points or 2.3 percent in that span. The Taiwan Stock Exchange now sits just beneath the 27,720-point plateau although it may stop the bleeding on Thursday.

RTTNews | 1h 4minuter sedan

Singapore Shares May Find Traction On Thursday

Singapore Shares May Find Traction On Thursday

The Singapore stock market has moved lower in two straight sessions, slumping more than 25 points or 0.6 percent along the way. The Straits Times Index now sits just beneath the 4,420-point plateau although it may find support on Thursday.

RTTNews | 1h 34minuter sedan

Rebound Anticipated For Malaysia Stock Market

Rebound Anticipated For Malaysia Stock Market

The Malaysia stock market on Wednesday snapped the two-day winning streak in which it had collected almost 15 points or 0.9 percent. The Kuala Lumpur Composite Index now sits just above the 1,620-point plateau although it figures to bounce higher again on Thursday.

RTTNews | 2h 4minuter sedan

South Korea Current Account Surplus $13.47 Billion In September

South Korea Current Account Surplus $13.47 Billion In September

South Korea posted a current account surplus of $13.47 billion in September, the Bank of Korea said on Wednesday - up from $9.15 billion.

RTTNews | 2h 17minuter sedan

Canadian Dollar Drops Against Most Majors

Canadian Dollar Drops Against Most Majors

The Canadian dollar fell against its most major counterparts in the New York session on Wednesday.

RTTNews | 2h 17minuter sedan

Bargain Hunting Likely To Boost Japan Stock Market

Bargain Hunting Likely To Boost Japan Stock Market

The Japan stock market has moved lower in consecutive trading days, plunging nearly 2,200 points or 4.2 percent in that span. The Nikkei 225 now rests just beneath the 50,200-point plateau although it's likely to open in the green on Thursday.

RTTNews | 2h 19minuter sedan

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