The oral presentation highlighted data from Zevra’s Expanded Access Program demonstrating a consistent safety profile CELEBRATION, Fla., April 15, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that new long-term real-world data from the arimoclomol expanded access program (EAP: NCT04316637 ) for the treatment of Niemann-Pick... Read More

CELEBRATION, Fla., April 10, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that it has entered into a new credit facility provided by leading biotech investors. Led by Perceptive Advisors and Healthcare Royalty, the new credit facility provides up to $100M in committed capital in three tranches: an initial draw of $60M at... Read More

Launch of OLPRUVA ® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M Conference call scheduled for today, March 28, 2024, at 4:30 p.m. ET CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company,... Read More

KP1077 demonstrates clinically meaningful benefits for key IH symptoms Top-line data provide key information for the design of a Phase 3 study CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial ( NCT05668754 ) evaluating the... Read More

CELEBRATION, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that it will participate in the upcoming 23 rd Annual Needham Virtual Healthcare Conference being held virtually on April 8-9, 2024. The Company’s presentation will take place on Monday, April 8, 2024, at 3:45 p.m. ET. Additionally, members of Zevra’s... Read More

CELEBRATION, Fla., March 18, 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 live audio webcast on Thursday, March 28, 2024, at 4:30 p.m. ET, to review its corporate and financial results for the fourth quarter and full year 2023. The link to the audio webcast will be accessible via the... Read More

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is September 21, 2024 CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally... Read More

CELEBRATION, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that Neil F. McFarlane, President and Chief Executive Officer of Zevra, will present at upcoming investor conferences in March 2024. Additionally, management will be available for one-on-one meetings with registered attendees at each of the conferences.... Read More

CELEBRATION, Fla., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that it will present at the upcoming Oppenheimer 34 th Annual Healthcare Life Sciences Conference being held virtually on Tuesday, February 13, 2024, at 9:20 a.m. ET. Additionally, members of Zevra’s management team will be available for one-on-one... Read More

CELEBRATION, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointment of Alvin Shih, MD, MBA, to the Company’s Board of Directors (Board) effective as of January 20, 2024. Dr. Shih has extensive experience in biotechnology leadership and rare disease therapeutics development and currently serves as President... Read More

Arimoclomol NDA has been assigned a PDUFA action date of June 21, 2024 CELEBRATION, Fla., Jan. 08, 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) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class... Read More

CELEBRATION, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointment of Adrian Quartel, M.D., FFPM, as Chief Medical Officer. Dr. Quartel brings more than 20 years of experience in the international pharmaceutical industry with senior roles in clinical development, pharmacovigilance and medical affairs. "It... Read More

CELEBRATION, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: 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 December 22, 2023. Based on standard NDA resubmission review timelines,... Read More

Acquisition includes OLPRUVA ® , an FDA-approved treatment for urea cycle disorders (UCDs), which propels Zevra into commercial stage, diversifying its revenue and providing scale Settlement of Acer’s warrant obligations through direct transaction with a healthcare focused investment fund adds quality healthcare investor to Zevra’s shareholder base CELEBRATION, Fla., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc.... Read More

Arimoclomol NDA resubmission remains on track for end of year filing Proposed acquisition of Acer Therapeutics on track to close Q4 2023 and will diversify Zevra’s revenue with FDA-approved OLPRUVA ® for urea cycle disorders (UCDs) Net revenue of $2.9M for Q3 2023 Ended Q3 2023 with $83.4M in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026 Conference call and live audio webcast... Read More

CELEBRATION, Fla., Oct. 31, 2023 (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 live audio webcast on Tuesday, November 7, 2023, at 8:00 a.m. ET, to review its corporate and financial results for the third quarter of 2023. The link to audio webcast will be accessible via the Investor Relations... Read More

CELEBRATION, Fla., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA), a rare disease therapeutics company, proudly supports the Niemann-Pick community on Global Niemann-Pick Disease Awareness Day and throughout Niemann-Pick Disease Awareness Month. Patient organizations like the International Niemann-Pick Disease Alliance (INPDA) and the National Niemann-Pick Disease Foundation (NNPDF) provide... Read More

Christal Mickle transitions back to Chief Development Officer CELEBRATION, Fla., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that Neil F. McFarlane has been named President and Chief Executive Officer of Zevra and appointed to the Board of Directors, effective October 10, 2023. Neil succeeds Christal M.M. Mickle who... Read More

Presentation to focus on the arimoclomol program for the treatment of Niemann-Pick Disease type C and related early access programs CELEBRATION, Fla., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that it will present data related to clinical study outcomes and its early access programs via both oral and poster... Read More

Data generated to date indicate SDX is well-tolerated across all doses and both dosing regimens studied, laying the groundwork for future Phase 3 trial Topline data from completed trial expected in the first half 2024, with potential to initiate Phase 3 trial by the end of 2024 CELEBRATION, Fla., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics... Read More

CELEBRATION, Fla., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that executive management will participate in a fireside chat at the Cantor Global Healthcare Conference on Wednesday, September 27, 2023, at 3:00 p.m. ET. Members of Zevra’s management team will be available for one-on-one investor meetings with... Read More

CELEBRATION, Fla., Sept. 09, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced a poster presentation featuring study data that underscores the cardiovascular safety profile of serdexmethylphenidate (SDX), the sole active pharmaceutical ingredient (API) in KP1077, Zevra’s investigational candidate for the treatment for idiopathic... Read More

CELEBRATION, Fla., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that executive management will present at the H.C. Wainwright 25 th Annual Global Investment Conference on Wednesday, September 13, 2023, at 8:30 a.m. ET. Members of Zevra’s management team will be available for one-on-one investor meetings with... Read More

Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure Zevra to assume commercialization efforts of OLPRUVA™, recently approved for the treatment of urea cycle disorders (UCDs) FDA-approved commercial asset expected to increase and diversify Zevra’s revenues OLPRUVA™ commercial operations provide Zevra scale and cost... Read More

Completed collaborative and productive pre-submission meeting with FDA for arimoclomol NDA in August 2023; filing expected in Q4 2023 Net revenue of $8.5M for Q2 2023, which includes $5 million milestone payment earned under the AZSTARYS® license agreement Ended Q2 2023 with $87.4 million in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026 Conference call and live audio webcast with... Read More

CELEBRATION, Fla., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) ("Zevra" or “the Company"), a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options, proudly welcomes Tom Anderson, a highly accomplished biopharma veteran, to its Board of Directors (the "Board"). Concurrently, the Company announces the... Read More

CELEBRATION, Fla., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, has announced that it will host a conference call and live audio webcast on Monday, August 14, 2023, at 8:30 a.m. ET, to review its corporate and financial results for the second quarter of 2023. The link to audio webcast with a slide... Read More

CELEBRATION, Fla., July 19, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, today announced their support of the upcoming National Niemann-Pick Disease Foundation’s (NNPDF) Family Support and Medical Conference. Members of the Zevra team will attend this event which is being held in Orlando, Florida, from July 20 through... Read More

CELEBRATION, Fla., June 20, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, announced its expected addition to the broad-market Russell 3000 ® Index and small-cap Russell 2000 ® Index in accordance with the 2023 Russell indexes annual reconstitution. Zevra anticipates that its inclusion in the Russell indexes will be... Read More

CELEBRATION, Fla., June 13, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, today announced executive management will participate in the Healthcare Virtual Conference Part II, presented by Maxim Group LLC and hosted by M-Vest, Tuesday, June 20 through Thursday, June 22, 2023. Zevra will participate in a fireside chat on... Read More

Zevra is a corporate sponsor of the Hypersomnia Foundation and Beyond Sleepy Conference CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare... Read More

Christal Mickle, Co-Founder and Chief Development Officer, appointed to serve as interim President and CEO effective June 1, 2023 Conference call and live audio webcast with slide presentation scheduled for today, May 15, 2023, 4:30 p.m. ET CELEBRATION, Fla., May 15, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, today... Read More

CELEBRATION, Fla., May 10, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that R. LaDuane Clifton, the Company’s Chief Financial Officer, will present at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 16, 2023, at 3:05 p.m. ET. In addition, members of Zevra’s management team... Read More

CELEBRATION, Fla., May 09, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, has announced that it will host a conference call and live audio webcast on Monday, May 15, 2023, at 4:30 p.m. ET, to review its corporate and financial results for the first quarter of 2023. The link to audio webcast with a slide presentation... Read More

CELEBRATION, Fla., May 08, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced changes to the Company’s Board of Directors (“Board”) and leadership. At the Company’s recent 2023 Annual Meeting of Stockholders (“Annual Meeting”), Zevra shareholders elected John B. Bode, Douglas W. Calder and Corey Watton... Read More

Zevra plans to expand KP1077 clinical program to address multiple rare sleep disorders with trials initiating in 2023 CELEBRATION, Fla., May 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration... Read More

Glass Lewis Recommends a Vote “FOR” Zevra’s Three Nominees Both ISS and Glass Lewis Recommend Shareholders DO NOT Vote “FOR” Any of the Mangless Nominees Zevra Urges Shareholders to Vote on the WHITE Proxy Card CELEBRATION, Fla., April 17, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that leading... Read More

Zevra seeks to expand KP1077 clinical program to address multiple rare sleep disorders CELEBRATION, Fla., April 04, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced the submission of an Investigational New Drug (IND) application seeking authorization from the U.S. Food and Drug Administration (“FDA”)... Read More

CELEBRATION, Fla., March 30, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that it has appointed Wendy L. Dixon, Ph.D., to the Company’s Board of Directors (the “Board”), effective immediately following the conclusion of the 2023 Annual Meeting of Stockholders (“2023 Annual Meeting”), to fill the... Read More

New Patent Issued Covering Serdexmethylphenidate (SDX), the Sole Active Pharmaceutical Ingredient in KP1077, Zevra’s Product Candidate for the Treatment of Idiopathic Hypersomnia (IH) CELEBRATION, Fla., March 17, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that it has joined the Sleep Data Initiative as a founding member.... Read More

Urges Shareholders to Vote "FOR" All Zevra Director Nominees on the WHITE Proxy Card CELEBRATION, Fla., March 15, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced it has filed its definitive proxy statement with the U.S. Securities and Exchange Commission (the “SEC”) in connection with the Company’s 2023... Read More

Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today, March 7, 2023, 8:30 a.m. ET Newly rebranded Zevra Therapeutics well positioned to become a commercially focused rare disease company Arimoclomol NDA resubmission on track to be filed as early as Q3 2023 KP1077 Phase 2 Trial on track to deliver preliminary data as early as Q3 2023 and top-line data as early as year-end 2023 AZSTARYS ® royalty... Read More

CELEBRATION, Fla., March 06, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that Richard W. Pascoe, the Company’s Chief Executive Officer, will participate in a fireside chat at the 35 th Annual Roth Conference on Monday, March 13, 2023, at 2:00 p.m. PT. In addition, Zevra management will be... Read More

Company’s common stock will begin trading on the Nasdaq Global Select Market under the new ticker symbol “ZVRA” starting today, March 1, 2023 New Company name, Zevra, is Greek for zebra, the internationally recognized symbol for the rare disease community CELEBRATION, Fla., March 01, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease... Read More

New name, Greek for “zebra,” is the internationally-recognized symbol for the rare disease community Branding reflects Company’s commitment to making rare disease therapies available through its research, development, and commercialization efforts The Company’s common shares will trade on The Nasdaq Global Select Market under the new ticker symbol “ZVRA” starting on or about March 1, 2023 CELEBRATION, Fla., Feb. 22, 2023... Read More

Daniel Gallo, Ph.D., Appointed Senior Vice President of Medical Affairs and Advocacy Abbi Maher, J.D., Named Vice President of Legal Affairs CELEBRATION, Fla., Jan. 31, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the development of treatments for rare central nervous system (CNS), neurodegenerative diseases, lysosomal storage disorders... Read More

CELEBRATION, Fla., Jan. 24, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the development of treatments for rare central nervous system (CNS) disorders, neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today announced that Richard W. Pascoe, Chief Executive Officer of KemPharm, has issued a Letter to... Read More

CELEBRATION, Fla., Jan. 18, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the development of treatments for rare central nervous system (CNS) disorders, neurodegenerative diseases, lysosomal storage disorders and related treatment areas, announced its partnership with the Hypersomnia Foundation , which engages, informs and champions the... Read More

Expanded roles for Guenther and Mickle support broader evolution into a leading rare disease company CELEBRATION, Fla., Jan. 11, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the development of treatments for rare central nervous system (CNS) disorders, neurodegenerative diseases, lysosomal storage disorders and related treatment areas,... Read More

Matthew R. Plooster named Chairman of the Board of Directors Richard W. Pascoe appointed Chief Executive Officer Travis C. Mickle, Ph.D. transitions to President Joshua Schafer appointed Chief Commercial Officer and Executive Vice President of Business Development CELEBRATION, Fla., Jan. 09, 2023 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics company focused on the... Read More

Trial designed as a multi-center, dose-optimizing, double-blind, placebo-controlled, randomized-withdrawal study to evaluate safety and efficacy of KP1077, as well as to assess the symptoms and severity of “brain fog” Interim efficacy and safety data expected as early as Q3 2023 CELEBRATION, Fla., Dec. 21, 2022 (GLOBE NEWSWIRE) - - KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a rare disease therapeutics... Read More