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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.
Zevra Therapeutics, Inc. (NasdaqGS: KMPH) announced its membership in the National Organization for Rare Disorders (NORD) and celebrated Rare Disease Day 2023. This commitment to the rare disease community aligns with Zevra’s mission to innovate therapies for conditions with unmet needs. Zevra, formerly KemPharm, emphasizes its focus on Niemann-Pick disease type C and idiopathic hypersomnia, with investigational products receiving orphan drug designations from the FDA. Zevra’s new name symbolizes its dedication, inspired by the zebra, a rare disease symbol. The company aims to drive progress in rare disease therapies.
Zevra Therapeutics (NasdaqGS: KMPH), formerly KemPharm, announced the filing of its preliminary proxy statement for the 2023 Annual Meeting of Stockholders, scheduled for April 25, 2023. The company has nominated three directors for re-election as part of a seven-member board focused on the company's transition to a commercially-driven rare disease therapeutics firm. The newly renamed Zevra is set to trade under the symbol 'ZVRA' starting March 1, 2023. The company is progressing with its FDA-approved products and pipeline, expecting to file an NDA for arimoclomol by Q3 2023, supported by a cash reserve of $102.9 million, projected to last until 2026.
Zevra Therapeutics, formerly KemPharm, Inc. (NasdaqGS: KMPH), has announced a conference call scheduled for March 7, 2023, at 8:30 a.m. ET. The call will cover the company's corporate and financial results for Q4 and full-year 2022. Investors can access the live audio webcast through the Investor Relations section on the company’s website, with an archive available for 90 days post-event. Participants can also join the call by dialing (800) 343-4849 (U.S.) or +1 (203) 518-9848 (International) using Conference ID: ZVRAQ422. Zevra focuses on developing therapies for rare diseases, leveraging data-driven approaches to address unmet medical needs.
Zevra Therapeutics, Inc. (KMPH) announces promising interim results from its Phase 2/3 trial of arimoclomol for Niemann-Pick Disease Type C (NPC) at the WORLD Symposium™ 2023. The four-year open-label extension study shows that arimoclomol may reduce long-term progression of NPC, a severe lysosomal disorder. The company plans to include these findings in an updated New Drug Application (NDA) to the FDA, expected to be resubmitted in Q3 2023. Currently, there are no FDA-approved treatments for NPC; only miglustat is available in the EU. Zevra aims to improve therapies for this rare disease with significant patient needs.
Zevra Therapeutics, Inc. (NasdaqGS: KMPH) has announced that two abstracts related to arimoclomol for Niemann-Pick disease type C (NPC) will be presented at the 19th Annual WORLD Symposium 2023 in Orlando, Florida. The first presentation evaluates the long-term effects of arimoclomol and is set for February 24, 2023, by Dr. Marc Patterson. The second abstract discusses the correlation between NPC severity scores and the Scale for the Assessment and Rating of Ataxia (SARA), presented by Dr. Christine í Dali on February 25, 2023. Zevra is also preparing a New Drug Application for arimoclomol, expected to be filed in Q3 2023.
On February 22, 2023, KemPharm, Inc. announced its rebranding as Zevra Therapeutics, reflecting its commitment to rare disease therapies. The new ticker symbol 'ZVRA' will begin trading on Nasdaq from March 1, 2023. CEO Richard W. Pascoe highlighted the significance of this change, aligning with the rare disease community's symbol, the zebra. Zevra is focused on developing treatments for unmet medical needs, including arimoclomol for Niemann-Pick type C disease, which has FDA orphan drug and Fast Track designations. The company is also advancing KP1077 for idiopathic hypersomnia, with a pivotal phase 3 study planned pending phase 2 results.
KemPharm, Inc. (KMPH) announced leadership changes with the appointments of Daniel Gallo, Ph.D., as Senior Vice President of Medical Affairs and Advocacy, and Abbi Maher, J.D., as Vice President of Legal Affairs. These newly created roles aim to enhance KemPharm's strategic vision of transforming into a commercially-focused rare disease company. Gallo brings extensive experience from Jaguar Gene Therapy and Orphazyme, focusing on arimoclomol and patient advocacy, while Maher has a strong legal background from Cytel Inc. and Cumberland Pharmaceuticals. The appointments support KemPharm's goal to improve interactions with the medical community and maximize business growth.
KemPharm, Inc. (NasdaqGS: KMPH) announced a shareholder update on January 24, 2023, from CEO Richard W. Pascoe, highlighting a strategic transformation towards rare disease therapeutics. The company aims to advance its arimoclomol and KP1077 programs throughout 2023, with a focus on regulatory approvals and commercial capabilities. Arimoclomol is being developed for Niemann-Pick disease type C, with an NDA resubmission targeted for Q3 2023, while KP1077 targets idiopathic hypersomnia and narcolepsy, with interim Phase 2 data expected in late 2023. KemPharm boasts a solid financial position with over $102 million in cash. Shareholder participation is encouraged in the upcoming April 2023 meeting.
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