Zevra Therapeutics Inc Stock Price, News & Analysis

Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) announced the submission of an IND application to the FDA to initiate a Phase 1 clinical trial for KP1077 in narcolepsy. This expands the ongoing Phase 2 trial for idiopathic hypersomnia (IH), with data potentially leading to pivotal Phase 3 studies for both conditions. The FDA confirmed no additional non-clinical studies are needed for KP1077, which is based on the established compound serdexmethylphenidate. Zevra is focused on advancing therapies for rare diseases and previously received various designations for its product Arimoclomol to treat Niemann-Pick disease type C.

Zevra Therapeutics (NasdaqGS: ZVRA) announced the appointment of Wendy L. Dixon, Ph.D., to its Board of Directors, effective immediately after the 2023 Annual Meeting on April 25, 2023. This follows the resignation of Dr. Travis Mickle, who co-founded Zevra. Dr. Dixon, with over 40 years of biopharma experience, previously held senior roles at Bristol Myers Squibb and Merck. Chairman Matthew Plooster emphasized her extensive industry experience as Zevra focuses on rare diseases. Dr. Dixon expressed excitement about contributing to Zevra's mission to provide solutions for patients with rare diseases.

Zevra Therapeutics (ZVRA) has announced its collaboration as a founding member of the Sleep Data Initiative, aimed at supporting research for sleep disorders. This initiative, led by RARE-X and the Sleep Consortium, emphasizes the importance of patient-owned data in advancing treatment development. Additionally, Zevra received U.S. Patent No. 11,505,537 for serdexmethylphenidate (SDX), the active ingredient in its lead product candidate, KP1077, targeting idiopathic hypersomnia (IH). The patent secures its intellectual property rights, extending until at least 2037. Zevra's commitment to addressing rare sleep disorders is underscored by its Phase 2 clinical trial for KP1077.

Zevra Therapeutics (NasdaqGS: ZVRA) has filed its definitive proxy statement with the SEC for the 2023 Annual Meeting of Stockholders set for April 25, 2023. The Company urges shareholders to vote 'FOR' the re-election of directors Richard W. Pascoe, David S. Tierney, M.D., and Christopher A. Posner using the WHITE proxy card. Zevra emphasizes that its current board has the right leadership for growth and value creation. The Company boasts a strong financial foundation with $102.9 million in cash as of December 31, 2022, and anticipates continued revenue from AZSTARYS royalties and its arimoclomol Early Access Program. The Board opposes nominees proposed by shareholder Daniel Mangless, citing risks to growth.

Zevra Therapeutics (ZVRA) announced its financial results for Q4 and FY 2022, revealing a net revenue of $2.3 million for Q4, down from $2.6 million in 2021. The company reported a net loss of $9 million, primarily due to R&D expenses of $6.4 million. For FY 2022, net revenue was $10.5 million, significantly down from $28.7 million in 2021, attributed to a lack of one-time regulatory milestone payments. Zevra holds $102.9 million in cash, extending its runway into 2026. The company is focused on advancing its arimoclomol NDA resubmission and KP1077 Phase 2 trial, with key data expected in Q3 and year-end 2023.

Zevra Therapeutics, previously known as KemPharm, announced that CEO Richard W. Pascoe will participate in a fireside chat at the 35th Annual Roth Conference on March 13, 2023, at 2:00 p.m. PT. During this session, Pascoe will outline the company’s innovative clinical, regulatory, and commercialization strategies aimed at advancing therapies for rare diseases. The chat will be accessible in-person and online, with a replay available for 90 days. Investors can also schedule one-on-one meetings with Zevra management from March 12-14. More details are available on Zevra's corporate website.

Zevra Therapeutics (Nasdaq: ZVRA), previously KemPharm, has begun trading under its new ticker symbol on the Nasdaq Global Select Market as of March 1, 2023. The company's rebranding reflects its commitment to the rare disease community. Zevra is developing arimoclomol, an investigational treatment for Niemann-Pick type C disease, which currently has no approved U.S. therapies. The FDA has granted arimoclomol orphan drug designation, Fast Track designation, and rare pediatric disease designation. Zevra is also progressing KP1077, aimed at treating idiopathic hypersomnia, now in a Phase 2 trial. Key milestones for 2023 include a planned resubmission of the NDA for arimoclomol.