Zevra Therapeutics (NASDAQ: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (“NDA”) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (“NPC”) to the U.S. Food and Drug Administration (“FDA”) on Dec. 22, 2023. Based on standard NDA resubmission review timelines, the company anticipates an acknowledgment letter from the FDA that the resubmission is complete and setting the PDUFA date within 30 days. Zevra expects the NDA to be classified as Class II, which would be subject to a review period by the FDA within six months from the date of submission. “The Zevra team has worked diligently to deliver a high quality and thorough resubmission of the NDA for arimoclomol following multiple interactions with the FDA and after incorporating direction from the agency,” said Neil McFarlane, president and chief executive officer of Zevra. “We continue to accelerate our launch preparations in anticipation of FDA approval and believe we are one step closer to getting arimoclomol into the hands of patients who are seeking a treatment.”

To view the full press release, visit https://ibn.fm/VmpmH

About Zevra Therapeutics

Zevra Therapeutics is a rare disease company melding science, data and patient needs to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory and commercialization strategies, the company is overcoming complex drug development challenges to bring much-needed therapies to patients. With both regulatory and clinical-stage product candidates, the company is building its commercial capability to make new therapies available to the rare disease community.

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)

For more information, please visit https://www.BioMedWire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/Disclaimer

BioMedWire
San Francisco, CA
www.BioMedWire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is powered by IBN