CELEBRATION

Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy

Retrieved on: 
Tuesday, April 4, 2023
Idiopathic hypersomnia, Narcolepsy, Research, Investigational New Drug, Somnolence, SDX, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Disease, Pharmaceutical industry, IH, Zebra

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”) to begin a Phase 1 clinical trial of KP1077 in narcolepsy. Once the clinical investigation plan proposed in the IND has been cleared to proceed by the FDA, Zevra plans to initiate its first of several Phase 1 clinical trials of KP1077 as early as the second quarter of 2023.

Key Points: 
  • 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”) to begin a Phase 1 clinical trial of KP1077 in narcolepsy.
  • Once the clinical investigation plan proposed in the IND has been cleared to proceed by the FDA, Zevra plans to initiate its first of several Phase 1 clinical trials of KP1077 as early as the second quarter of 2023.
  • KP1077 is also currently being evaluated in a Phase 2 clinical trial for the treatment of idiopathic hypersomnia (“IH”).
  • Those data have the potential to support not only the advancement of KP1077 into a pivotal Phase 3 study in IH, but also a Phase 3 trial in narcolepsy.

Zevra Therapeutics Appoints Biopharma Veteran Wendy Dixon, Ph.D., to Board of Directors

Retrieved on: 
Thursday, March 30, 2023
GSK plc, Drug development, Audit, Compensation, Bristol Myers Squibb, Zebra, Patient, Annual general meeting, Chairperson, Merck, Plan, Rare, Therapy, Global marketing, Janssen Pharmaceuticals, Disease, Pharmaceutical industry, Shareholder, West Pharmaceutical Services explosion

Dr. Dixon also held senior roles at Merck, West Pharmaceuticals, Osteotech, Centocor and GlaxoSmithKline.

Key Points: 
  • Dr. Dixon also held senior roles at Merck, West Pharmaceuticals, Osteotech, Centocor and GlaxoSmithKline.
  • Matthew R. Plooster, Chairman of the Zevra Board, said, “Wendy Dixon’s appointment demonstrates Zevra’s ongoing commitment to strong corporate governance, deep industry experience and diverse, independent thought.
  • We began a search for new directors in 2022 as part of our strategic shift toward rare diseases, and since then have added two highly qualified directors in Chris Posner and Wendy Dixon.
  • Dr. Mickle will continue to support Zevra’s drug development and regulatory approval activities as a scientific advisor.

Zevra Therapeutics Announces Collaboration with RARE-X and the Sleep Consortium as Founding Member of New Sleep Data Initiative

Retrieved on: 
Friday, March 17, 2023
Acceleration, 1836 U.S. Patent Office fire, Patent, Partnership, Drug development, Consortium, Idiopathic hypersomnia, Sole, United States Patent and Trademark Office, Sleep, IH, Narcolepsy, Data collection, Research, CDH, Methylphenidate, Patient, Somnolence, SDX, Ecosystem, Salt, Therapy, Phenotype, Global Genes, Treatment, Disease, Pharmaceutical industry, Zebra

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. The new data collection platform is led by RARE-X and the Sleep Consortium to provide access to research-grade, patient-owned data to support the acceleration of research and treatment development for sleep disorders.

Key Points: 
  • The new data collection platform is led by RARE-X and the Sleep Consortium to provide access to research-grade, patient-owned data to support the acceleration of research and treatment development for sleep disorders.
  • “Marking World Sleep Day today, we are proud to announce this important collaboration and our role as a founding member of this significant initiative to support acceleration and advancement of sleep research programs,” said Richard W. Pascoe, Chief Executive Officer of Zevra.
  • Sleep Consortium is a not-for-profit organization working to support research and drug development for Central Disorders of Hypersomnolence (CDH) and other related sleep disorders.
  • “As a founding member of the Sleep Data Initiative, Zevra Therapeutics recognizes the need for collaboration to develop creative solutions to improve the lives of patients with sleep disorders,” said Lindsay Jesteadt, Ph.D., Chief Executive Officer and Co-Founder of Sleep Consortium.

Zevra Therapeutics Files Definitive Proxy Statement and Mails Letter to Shareholders

Retrieved on: 
Wednesday, March 15, 2023
Idiopathic hypersomnia, Drug development, Therapy, Annual general meeting, Proxy, Niemann–Pick disease, Letter, Special access program, Investment, Disease, Growth, IH, NDA, Security (finance), Management, Zebra, Shareholder

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 Annual Meeting of Stockholders (“Annual Meeting”), which is scheduled to take place on April 25, 2023. Shareholders of record as of March 1, 2023, will be entitled to vote at the meeting.

Key Points: 
  • Shareholders of record as of March 1, 2023, will be entitled to vote at the meeting.
  • In conjunction with the definitive proxy filing, the Company has mailed a letter to Zevra shareholders recommending they vote "FOR" the Company's three highly qualified directors up for re-election on the WHITE proxy card — Richard W. Pascoe, David S. Tierney, M.D., and Christopher A. Posner.
  • The full letter has been filed with the SEC and can be found on the investor section of the Company's website at https://investors.zevra.com .
  • Zevra shareholders who need assistance in completing the WHITE proxy card or have questions regarding the Zevra Annual Meeting may contact the Company’s proxy solicitor:
    If you have any questions about how to vote your shares, or need additional assistance, please contact:

Zevra Therapeutics Reports Fourth Quarter and Fiscal Year 2022 Financial Results and Corporate Updates

Retrieved on: 
Tuesday, March 7, 2023
Corporation, History, Zebra, PDUFA, Growth, New Drug Application, Investment, Medical Affairs Bureau, Niemann–Pick disease, EAP, Acquisition, NDA, Therapy, Business development, Safety, Corium, Rare, Webcast, Conference call, Conference, Depreciation, R, Legal Affairs, Disease, Collection, Research, Idiopathic hypersomnia, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, NPC, G&A, IH, Food, SDX, Senior, Exercise, Broadcasting, Pharmaceutical industry, Sales, Management, Cryptocurrency

ET

Key Points: 
  • ET
    Strong balance sheet with cash, cash equivalents and investments of $102.9 million which extends the cash runway into 2026
    CELEBRATION, Fla., March 07, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra,” or “the Company,” formerly “KemPharm, Inc.”), a rare disease therapeutics company, today reported its financial results for the fourth quarter and year ended December 31, 2022.
  • “Zevra is a company transformed, with a new strategic purpose to deliver novel therapeutics to patients with rare diseases,” said Richard W. Pascoe, Chief Executive Officer of Zevra Therapeutics.
  • Overview of Fourth Quarter (Q4) and Full-Year (FY) 2022 Financial Results:
    Net revenue for Q4 2022 was $2.3 million, as compared to Q4 2021 net revenue of $2.6 million.
  • ET, to discuss its corporate and financial results for the fourth quarter and full-year 2022.

Zevra Therapeutics to Present at 35th Annual Roth Conference

Retrieved on: 
Monday, March 6, 2023
Conference, Therapy, Disease, Pharmaceutical industry, Zebra

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 35th Annual Roth Conference on Monday, March 13, 2023, at 2:00 p.m. PT.

Key Points: 
  • 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 35th Annual Roth Conference on Monday, March 13, 2023, at 2:00 p.m. PT.
  • In addition, Zevra management will be available for in-person or virtual one-on-one investor meetings during the conference from March 12-14.
  • Pascoe will discuss the Company’s unique, data-driven clinical, regulatory, and commercialization strategies to advance rare disease therapies to address areas of unmet need.
  • The fireside chat will be held in-person and available online Monday, March 13, 2023, from 2:00-2:25 p.m. PT.

Zevra Therapeutics Begins Trading as ZVRA

Retrieved on: 
Wednesday, March 1, 2023
Therapy, Sleep disorder, Zebra, Disease, Bone marrow, Brain, FDA, New Drug Application, Liver, Idiopathic hypersomnia, Niemann–Pick disease, Narcolepsy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Caregiver, Food, Spleen, NPC, Pharmaceutical industry, IH

CELEBRATION, Fla., March 01, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, announced today that it will begin trading under the new ticker symbol “ZVRA” on the Nasdaq Global Select Market at market open today, March 1, 2023.

Key Points: 
  • Company’s common stock will begin trading on the Nasdaq Global Select Market under the new ticker symbol “ZVRA” starting today, March 1, 2023
    CELEBRATION, Fla., March 01, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, announced today that it will begin trading under the new ticker symbol “ZVRA” on the Nasdaq Global Select Market at market open today, March 1, 2023.
  • Zevra is currently developing arimoclomol, an orally-delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick type C disease (“NPC”).
  • The U.S. Food and Drug Administration (“FDA”) has granted arimoclomol orphan drug designation, Fast Track designation, and rare pediatric disease designation for the treatment of NPC.
  • Pending the results from that trial, the Company plans to conduct a pivotal Phase 3 study in IH, with the potential to study an expanded indication in narcolepsy.

Zevra Therapeutics Reiterates Commitment to Rare Disease Community as New Corporate Council Member of the National Organization for Rare Disorders (NORD)

Retrieved on: 
Tuesday, February 28, 2023
National Organization for Rare Disorders, Therapy, NORD, Rare, Disease, Research, Patient, Corporate Council on Africa, Idiopathic hypersomnia, KMPH, Niemann–Pick disease, Rare Disease Day, Symbolism, Pharmaceutical industry, Zebra

CELEBRATION, Fla., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: KMPH) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that it has become a Corporate Council member of the National Organization for Rare Disorders (NORD) and reiterated its commitment to the rare disease community by celebrating Rare Disease Day 2023.

Key Points: 
  • CELEBRATION, Fla., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: KMPH) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced that it has become a Corporate Council member of the National Organization for Rare Disorders (NORD) and reiterated its commitment to the rare disease community by celebrating Rare Disease Day 2023.
  • A rare disease is a condition that impacts fewer than 200,000 people in the United States, with over 7,000 known rare diseases nationally affecting nearly 1 in 10 people.
  • As a company focused on advancing therapies for rare diseases, Zevra stands with NORD and the rare disease community today and every day.
  • “We enthusiastically welcome Zevra as an important partner for our community and appreciate the symbolism of its new name inspired by the zebra – the international symbol of the rare disease community."

Zevra Therapeutics, a Rare Disease Therapeutics Company, Files Preliminary Proxy

Retrieved on: 
Monday, February 27, 2023
Safety, Therapy, Quality of life, Annual, Disease, Drug development, Annual general meeting, FDA, Investment, Patient, Growth, Ageing, Corium, KMPH, History, Niemann–Pick disease, Idiopathic hypersomnia, New Drug Application, ADHD, Annual Meetings of the International Monetary Fund and the World Bank Group, Pharmaceutical industry, Shareholder, Zebra

With the re-election of these serving directors, the Zevra Board will comprise seven highly qualified individuals, five of whom are independent and each of whom is actively engaged in overseeing Zevra’s transformation into a commercially driven rare disease therapeutics company.

Key Points: 
  • With the re-election of these serving directors, the Zevra Board will comprise seven highly qualified individuals, five of whom are independent and each of whom is actively engaged in overseeing Zevra’s transformation into a commercially driven rare disease therapeutics company.
  • “Our name change and new Zevra brand are key steps in advancing our company’s focus on rare disease therapeutic research, development and commercialization,” said Matthew R. Plooster, Chairman of the Zevra Board of Directors.
  • Proxy battles can be costly and distracting, and as such, I intend to vote in favor of the Zevra slate.
  • The Zevra Board recommends that stockholders discard any proxy materials from Daniel Mangless and vote using the WHITE proxy card they will receive as part of the definitive proxy materials that will be delivered by the Company.

Zevra Therapeutics to Report Fourth Quarter and Full-Year 2022 Results

Retrieved on: 
Monday, February 27, 2023
Disease, Therapy, KMPH, Webcast, Zebra

CELEBRATION, Fla., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: KMPH) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, has announced that the Company will host a conference call and live audio webcast on Tuesday, March 7, 2023, at 8:30 a.m.

Key Points: 
  • CELEBRATION, Fla., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: KMPH) (Zevra, or the Company, formerly KemPharm, Inc.), a rare disease therapeutics company, has announced that the Company will host a conference call and live audio webcast on Tuesday, March 7, 2023, at 8:30 a.m.
  • ET, to discuss its corporate and financial results for the fourth quarter and full-year 2022.
  • The audio webcast with a slide presentation will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/ .
  • An archive of the webcast and presentation will be available for 90 days beginning at approximately 9:30 a.m.