Zevra Therapeutics Inc Stock Price, News & Analysis

Zevra Therapeutics (NASDAQ: ZVRA) reported Q2 2024 financial results and corporate highlights. Key points include:

1. FDA advisory committee voted favorably on arimoclomol's effectiveness for NPC treatment; PDUFA date set for September 21, 2024.

2. Pro forma cash position of $113.8 million as of June 30, 2024, including recent public offering.

3. Q2 2024 net revenue of $4.4 million, down from $8.5 million in Q2 2023.

4. Net loss of $19.9 million ($0.48 per share) in Q2 2024, compared to $2.6 million ($0.08 per share) in Q2 2023.

5. Cash runway extended into Q1 2027, excluding potential arimoclomol revenue.

Zevra Therapeutics (Nasdaq: ZVRA) has announced the pricing of an underwritten public offering of 9,230,770 shares of its common stock at $6.50 per share. This offering is expected to generate gross proceeds of approximately $60.0 million. The company has also granted underwriters a 30-day option to purchase up to an additional 1,384,615 shares. Cantor and William Blair are acting as joint book-running managers, with Citizens JMP and H.C. Wainwright & Co. as co-managers. The offering, subject to customary closing conditions, is anticipated to close on August 12, 2024. This public offering is being conducted under a registration statement filed with the SEC on June 4, 2024, which became effective on June 13, 2024.

Zevra Therapeutics (Nasdaq: ZVRA) has announced a proposed underwritten public offering of its common stock. The company plans to offer all shares and grant underwriters a 30-day option to purchase up to an additional 15% of shares at the public offering price. Cantor and William Blair are acting as joint book-running managers. The offering is subject to market conditions, with no assurance of completion or final terms. It will be made through a prospectus supplement and accompanying prospectus filed with the SEC. This announcement does not constitute an offer to sell or solicitation of an offer to buy securities.

Zevra Therapeutics (NASDAQ: ZVRA), a rare disease therapeutics company, has announced its participation in Canaccord Genuity's 44th Annual Growth Conference in Boston, MA. Neil F. McFarlane, President and CEO of Zevra, will present on Wednesday, August 14, 2024, at 10:30 a.m. ET.

The executive team will be available for one-on-one investor meetings with registered attendees throughout the conference. Interested parties can access live webcasts of the presentation through the 'Events & Presentations' section of Zevra's website at investors.zevra.com.

Zevra Therapeutics (NasdaqGS: ZVRA) announced that the FDA's Genetic Metabolic Diseases Advisory Committee voted 11-5 in favor of arimoclomol's effectiveness in treating Niemann-Pick disease type C (NPC). The committee's recommendation will be considered by the FDA as it reviews the arimoclomol New Drug Application (NDA), with a PDUFA action date of September 21, 2024. Zevra's CEO, Neil F. McFarlane, expressed confidence in arimoclomol's clinical benefit based on data from the pivotal trial, long-term open-label extension study, and expanded access programs. The GeMDAC's decision, while not binding, is a positive step towards potential FDA approval for this rare disease treatment.

Zevra Therapeutics (NASDAQ: ZVRA), a rare disease therapeutics company, has announced it will host a conference call and audio webcast on August 13, 2024, at 4:30 p.m. ET to review its corporate and financial results for the second quarter of 2024. The audio webcast will be accessible through the Investor Relations section of the company's website. Investors can join the meeting via conference call using the provided dial-in numbers. An archive of the webcast will be available for 90 days starting approximately at 5:30 p.m. ET on the same day.

Zevra Therapeutics announced that the FDA will review its New Drug Application (NDA) for arimoclomol on August 2, 2024. Arimoclomol is an oral treatment for Niemann-Pick disease type C (NPC), a rare genetic disorder. This review will be conducted by the Genetic Metabolic Diseases Advisory Committee (GeMDAC), newly formed by the FDA. The FDA plans to release background materials two business days before the meeting, and a Prescription Drug User Fee Act (PDUFA) action date has been set for September 21, 2024. Zevra's CEO, Neil F. McFarlane, emphasized the importance of this review for the NPC community, which lacks an approved therapy.

Zevra Therapeutics announced the appointment of Rahsaan W. Thompson as Chief Legal Officer, Secretary, and Compliance Officer, and Alison Peters as Chief People Officer. Both bring extensive experience to their roles, vital for Zevra's growth in rare disease therapeutics. Mr. Thompson, with over 25 years in the biotech sector, has vast expertise in corporate governance, SEC compliance, and litigation. Ms. Peters, with more than 20 years in human capital management, excels in talent acquisition and corporate culture. Additionally, both executives received inducement equity awards, with Mr. Thompson granted 200,000 restricted stock units and Ms. Peters 150,000, vesting over three years. These appointments are aligned with Zevra's strategic goals to enhance its commercial capabilities and advance its rare disease portfolio.

Zevra Therapeutics has partnered with Orsini Specialty Pharmacy as the new pharmacy provider for OLPRUVA® (sodium phenylbutyrate), used to manage certain urea cycle disorders (UCDs) in both adults and children. UCDs are rare genetic conditions that hinder the body's ability to eliminate excess ammonia, which can lead to severe neurological damage if untreated. OLPRUVA® helps mitigate this risk by acting as a nitrogen scavenger to remove excess ammonia. This collaboration aims to enhance access to OLPRUVA® for patients struggling with UCDs.