FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024
Pro forma June 30, 2024, cash, cash equivalents, investments and net proceeds from underwritten public offering total $113.8 million following the closing on August 12, 2024
Conference call scheduled for today, August 13, 2024, at 4:30 p.m. ET
Arimoclomol
- On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.
- The GeMDAC reviewed comments received from independent experts, NPC patients, and patient advocacy group representatives, and voted favorably that arimoclomol is effective in the treatment of NPC.
- On Friday, August 9, 2024, the Company received the first round of labeling comments, and is working closely with the FDA.
Conference Call Information
Zevra will host a conference call and audio webcast today at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2024.
The audio webcast will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the audio webcast will be available for ninety (90) days beginning at approximately 5:30 p.m. ET, on August 13, 2024.
Additionally, interested participants and investors may access the conference call by dialing either:
- (800) 225-9448 (United States)
- +1 (203) 518- 9708 (International)
- Conference ID: ZVRAQ224
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