CELEBRATION, Fla., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with Niemann-Pick disease type C (NPC). "We are extremely pleased with the committee's recognition of the benefits of arimo ...

CELEBRATION, Fla., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with Niemann-Pick disease type C (NPC). "We are extremely pleased with the committee's recognition of the benefits of arimo ...

CELEBRATION, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced that it will host a conference call and audio webcast on Tuesday, August 13, 2024, at 4:30 p.m. ET, to review its corporate and financial results for the second quarter of 2024. The link to the audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by ...

CELEBRATION, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced that it will host a conference call and audio webcast on Tuesday, August 13, 2024, at 4:30 p.m. ET, to review its corporate and financial results for the second quarter of 2024. The link to the audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by ...

Zevra Therapeutics, Inc. (ZVRA) announced that the FDA has indicated that it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee ("GeMDAC") to review the company's new drug application (NDA) for pipeline candidate arimoclomol. NPC is an ultra-rare, progressive, and neurodegenerative lysosomal storage disorder characterized by an inability of the body to transport cholesterol and other lipids within the cell, leading to an accumulation of these substances in various ...

The stock rallied after the FDA indicated that it would convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee to review the company's new drug application (NDA) for pipeline candidate arimoclomol. The NDA is seeking approval for arimoclomol as an orally delivered, first-in-class treatment for Niemann-Pick disease type C. The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> While earnings an ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From to Commission File Number: 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Juris ...

Zevra Therapeutics, Inc. (NASDAQ:ZVRA) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Nichol Ochsner - VP, Investor Relations & Corporate Communications Neil Mcfarlane - President, CEO & Director LaDuane Clifton - CFO, Treasurer, Secretary Josh Schafer - Chief Commercial Officer & EVP, Business Development Adrian Quartel - Chief Medical Officer Conference Call Participants Tim Lugo - William Blair & Company Jonathan Aschoff - ROTH MKM Louise Chen - Cantor Fitzgerald Oren Livnat ...

Exhibit 99.1 Zevra Therapeutics Reports First Quarter 2024 Financial Results and Corporate Updates Full commercial launch of OLPRUVA at the end of January 2024, with market access growing to ~75% of covered lives as of May 1, 2024 Arimoclomol NDA review underway with PDUFA date of September 21, 2024 Reported positive topline results from KP1077 Phase 2 Trial in idiopathic hypersomnia, with full data to be presented at SLEEP 2024 in early June 2024 Conference call scheduled for today, May 8, 2024, at 8:00 a. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to _____ Commission File No. 001-36913 Zevra Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894398 (State or Other Jurisdiction of I ...