Financial Performance - Q2 2025 net revenue reached $25.9 million, with product net revenue of $21.8 million, a significant increase from $4.4 million in Q2 2024[9] - Net income for Q2 2025 was $74.7 million, or $1.24 per basic share, compared to a net loss of $(19.9) million in Q2 2024[9] - Net revenue for the three months ended June 30, 2025, was $25.881 million, a significant increase from $4.449 million in the same period of 2024, representing a growth of 481%[33] - The company reported a net income of $74.707 million for the three months ended June 30, 2025, compared to a net loss of $19.925 million in the same period of 2024[33] - The accumulated deficit decreased to $433.681 million as of June 30, 2025, from $505.289 million at the end of 2024, showing improvement in financial health[35] Operating Expenses - The adjusted net loss for Q2 2025 was $(3.2) million, or $(0.06) per share, excluding one-time items[9] - Operating expenses for Q2 2025 were $24.2 million, up from $23.1 million in Q2 2024, primarily due to increased personnel-related costs[9] - Operating expenses for the three months ended June 30, 2025, were $24.215 million, slightly higher than $23.125 million in the same period of 2024[33] Assets and Liabilities - Cash, cash equivalents, and securities stood at $217.7 million as of June 30, 2025, providing sufficient resources for strategic priorities[9] - Total current assets increased to $226.337 million as of June 30, 2025, up from $86.027 million at the end of 2024, reflecting a growth of 163%[35] - The company’s cash and cash equivalents rose to $47.712 million as of June 30, 2025, compared to $33.785 million at the end of 2024, indicating a 41% increase[35] - Total liabilities as of June 30, 2025, were $139.047 million, a slight increase from $138.461 million at the end of 2024[35] - The company’s total stockholders' equity increased to $117.230 million as of June 30, 2025, compared to $39.666 million at the end of 2024, reflecting a growth of 195%[35] Product Development and Market Access - MIPLYFFA achieved 7 prescription enrollments in Q2 2025, totaling 129 since launch, with market access covering 52% of lives[6] - OLPRUVA recorded 1 prescription enrollment in Q2 2025, bringing the total to 29, with market access at 79% of covered lives[6] - The company enrolled 7 patients in the Phase 3 DiSCOVER trial for celiprolol, totaling 39 enrolled patients[6] - The company submitted a Marketing Authorization Application for arimoclomol to the European Medicines Agency, meeting its guidance for submission in the second half of 2025[6] Sale of Assets - The company completed the sale of its Pediatric Rare Disease Priority Review Voucher for gross proceeds of $150.0 million, enhancing its balance sheet[5] - The company recorded a gain on the sale of PRV amounting to $148.325 million for the three months ended June 30, 2025[33] - Research and development expenses for the six months ended June 30, 2025, totaled $6.691 million, down from $22.798 million in the same period of 2024[33]

Core Insights - Zevra Therapeutics reported Q2 2025 net revenue of $25.9 million, significantly up from $4.4 million in Q2 2024, driven primarily by product net revenue of $21.8 million from MIPLYFFA [1][8] - The company completed the sale of its Pediatric Rare Disease Priority Review Voucher (PRV) for $150 million, enhancing its balance sheet as it advances commercial launches and development programs [1][5] - Zevra submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for arimoclomol, aimed at treating Niemann-Pick Disease Type C [1][7] Commercial Highlights - MIPLYFFA achieved 7 prescription enrollments in Q2 2025, totaling 129 since its launch, with market access reaching 52% of covered lives [7] - OLPRUVA saw 1 prescription enrollment in Q2 2025, bringing the total to 29, with market access increasing to 79% of covered lives [7] Financial Highlights - Total revenue for Q2 2025 was $25.9 million, including $21.5 million from MIPLYFFA, $0.3 million from OLPRUVA, and $2.6 million in net reimbursements for arimoclomol [8] - Operating expenses were $24.2 million, with R&D expenses decreasing to $3.4 million, while SG&A expenses increased to $20.8 million [14] - The company reported a net income of $74.7 million for Q2 2025, compared to a net loss of $19.9 million in Q2 2024 [10][14] Pipeline and Innovation Highlights - Arimoclomol has been designated as an Orphan Medicinal Product by the EMA, and the company is on track with its guidance for submission in the second half of 2025 [7][17] - Zevra enrolled 7 patients in the Phase 3 DiSCOVER trial of celiprolol for Vascular Ehlers-Danlos Syndrome during Q2 2025, totaling 39 enrolled patients [7] Corporate Highlights - As of June 30, 2025, Zevra's cash, cash equivalents, and securities totaled $217.7 million, providing sufficient resources for strategic priorities [14] - The company has granted inducement equity awards to 9 individuals totaling 54,875 shares of restricted stock units and 49,750 options to purchase common stock [15][16]

Core Viewpoint - The article emphasizes the importance of confirming the sustainability of stock trends for successful short-term investing, highlighting the utility of a specific screening strategy to identify stocks with strong fundamentals and positive price momentum [1][2]. Group 1: Stock Screening Strategy - The "Recent Price Strength" screen is designed to identify stocks with sufficient fundamental strength to maintain their upward price trends, focusing on those trading in the upper portion of their 52-week high-low range, indicating bullishness [3]. - Zevra Therapeutics (ZVRA) is highlighted as a strong candidate for trend investing, having increased by 43.9% over the past 12 weeks, reflecting investor confidence in its potential [4]. - ZVRA has maintained a price increase of 0.9% over the last four weeks, indicating that the upward trend is still intact, and it is currently trading at 85.2% of its 52-week high-low range, suggesting a potential breakout [5]. Group 2: Fundamental Strength - ZVRA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, which are critical for near-term price movements [6]. - The stock also has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [7]. - The article suggests that the price trend for ZVRA is unlikely to reverse soon, indicating a favorable outlook for investors [8].

Company Overview - Zevra Therapeutics, Inc. is a commercial-stage company focused on developing therapies for rare diseases with limited or no treatment options, aiming to provide life-changing therapeutics to affected individuals [3]. Upcoming Events - Members of Zevra's executive leadership team will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference in Boston, MA, on August 13, 2025, at 1:00 p.m. ET [1]. - Management will also be available for one-on-one meetings with registered conference attendees [2]. Investor Relations - A live webcast of the fireside chat will be accessible via the "Events & Presentations" section on Zevra's Investor Relations website [2].

The consensus EPS estimate for the quarter has been revised 10.53% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise While the sustainability of the immediate price change and future earnings expe ...

Core Points - Zevra Therapeutics, Inc. will report its corporate and financial results for Q2 2025 on August 12, 2025, after market close, followed by a conference call at 4:30 p.m. ET [1] - The audio webcast of the conference call will be available on Zevra's Investor Relations website, with a replay accessible for 90 days [2] - Zevra is a commercial-stage company focused on developing therapies for rare diseases, aiming to provide life-changing treatments where options are limited or nonexistent [3] Company Overview - Zevra Therapeutics combines science, data, and patient needs to create transformational therapies for rare diseases [3] - The company employs unique, data-driven strategies for drug development and commercialization to address complex challenges in making new therapies available [3]

Core Viewpoint - Zevra Therapeutics (ZVRA) has seen a 16.8% increase in share price over the past four weeks, closing at $10.99, with analysts suggesting a potential upside of 117.1% based on a mean price target of $23.86 [1][4]. Price Targets and Analyst Estimates - The mean price target is derived from seven short-term estimates with a standard deviation of $3.39, indicating a range of potential outcomes; the lowest estimate is $19.00 (72.9% increase), while the highest is $29.00 (163.9% increase) [2][9]. - A low standard deviation among price targets suggests a strong consensus among analysts regarding the stock's price direction, although it does not guarantee that the stock will reach the average target [9][10]. Earnings Estimates and Market Sentiment - Analysts are optimistic about ZVRA's earnings prospects, as indicated by a significant increase in earnings estimate revisions, with a 337.1% rise in the Zacks Consensus Estimate for the current year [11][12]. - ZVRA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, which supports the stock's potential for near-term upside [13]. Conclusion on Price Movement - While consensus price targets may not be entirely reliable, the positive direction indicated by earnings estimate revisions appears to be a valid guide for potential stock price movements [14].

CELEBRATION, Fla., July 28, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare diseases, announced the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC). NPC is an ultra-rare, neurological disease caused by genetic mutations that result in lipid ...

Core Insights - Zevra Therapeutics is actively participating in the 42nd Annual Meeting of the Southeastern Regional Genetics Group (SERGG), showcasing its therapies MIPLYFFA and OLPRUVA, which are approved for treating rare diseases [1][2] Group 1: MIPLYFFA (arimoclomol) - MIPLYFFA is approved in the U.S. for treating Niemann-Pick disease type C (NPC) and has shown disease-modifying activity leading to sustained disease stabilization in patients over multiple years [2][7] - Data from an Expanded Access Program (EAP) indicates that patients treated with MIPLYFFA experienced stable disease over up to 3 years, contrasting with the average progression of 1.0–2.0 points per year on the Niemann-Pick type C Clinical Severity Scale [3] - A 48-month open-label trial demonstrated that patients treated with MIPLYFFA experienced sustained reduction in disease progression for at least 5 years [3] - MIPLYFFA targets the pathophysiology of NPC through two pathways, enhancing the expression of genes in the Coordinated Lysosomal Expression and Regulation (CLEAR) network [3] Group 2: OLPRUVA (sodium phenylbutyrate) - OLPRUVA is approved for treating certain patients with urea cycle disorders (UCDs) and can be administered via a gastrostomy tube, which is significant for managing UCD in some patients [2][4][18] - Studies confirm that OLPRUVA meets administration criteria through gastrostomy tubes at evaluated doses and volumes [4] - OLPRUVA is indicated for long-term management of UCDs in adults and children weighing 44 pounds (20 kg) or greater, but is not used for acute hyperammonemia [18] Group 3: Company Overview - Zevra Therapeutics focuses on developing therapies for rare diseases, aiming to provide life-changing treatments for patients with limited or no options [23] - The company employs unique, data-driven strategies to overcome challenges in drug development and commercialization [23]

Company Overview - Zevra Therapeutics (ZVRA) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook for investors [3] Price Performance - ZVRA shares have increased by 28.64% over the past week, significantly outperforming the Zacks Medical - Drugs industry, which rose by 1.75% during the same period [5] - Over the past month, ZVRA's price change is 45.18%, compared to the industry's 1.25% [5] - In the last quarter, ZVRA shares have risen by 74.97%, and over the past year, they have gained 95.57%, while the S&P 500 has only moved 16.04% and 12.11%, respectively [6] Trading Volume - ZVRA's average 20-day trading volume is 1,122,698 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Estimates - In the past two months, three earnings estimates for ZVRA have been revised upwards, with no downward revisions, leading to an increase in the consensus estimate from $0.31 to $1.35 [9] - For the next fiscal year, two estimates have also moved upwards, with no downward revisions during the same period [9] Conclusion - Given the strong momentum indicators and positive earnings outlook, ZVRA is positioned as a solid momentum pick for investors [11]