Zevra Therapeutics Inc

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Zevra Therapeutics excels in rare disease focus and financial performance

Zevra Therapeutics showcases strong financial performance, strategic focus on rare diseases, and a commitment to product innovation. Challenges include meeting FDA requirements and defining key endpoints for program approvability. The company is well-positioned to capitalize on growth opportunities through pipeline expansion and premium product offerings.

Zevra Therapeutics excels in Q1, pivots to rare disease focus

Zevra Therapeutics reported a solid Q1 2023 performance, highlighting key milestones, leadership changes, and a renewed focus on rare disease therapeutics. The company's commitment to ongoing clinical trials, revenue diversification, and shareholder value creation underscores its long-term growth strategy. Challenges in managing expectations and leadership transitions must be navigated to unlock future opportunities and sustain momentum.

Zevra Therapeutics excels in Q2, poised for arimoclomol launch

Zevra Therapeutics demonstrated strong financial performance, operational stability, and clinical advancements in Q2 2023, positioning the company for future growth and innovation.
While facing challenges such as regulatory requirements and leadership transitions, Zevra's strategic strengths in patient-centric approaches and market development offer opportunities for sustained success.
With a focus on product approvals, market expansion, and regulatory compliance, Zevra is poised to capitalize on the potential of arimoclomol and drive value for stakeholders.

Zevra Therapeutics focuses on rare diseases, eyes strategic growth

Zevra Therapeutics' Q3 2023 earnings call highlighted revenue growth, strategic focus on rare diseases, and upcoming milestones. The company faces challenges in managing expenses and FDA interactions but has opportunities for growth through acquisitions and product advancements.

Zevra Therapeutics excels in Q4 2023, poised for market growth

Zevra Therapeutics demonstrated robust financial performance, strategic advancements, and positive clinical outcomes in Q4 2023.
While facing challenges in product launches and FDA reviews, the company's strong financial position and commitment to patient care are notable strengths.
Opportunities abound in market expansion, FDA approvals, and strategic collaborations to drive growth and market differentiation.

Zevra Therapeutics advances key drug launches and strengthens financial position

Zevra Therapeutics made significant progress in key initiatives like OLPRUVA launch and arimoclomol FDA milestone.
Successful debt refinancing strengthened the balance sheet and extended the cash runway into 2026.
Despite challenges like increased net loss and analyst queries, the company's pipeline progress offers growth opportunities.

Zevra Therapeutics advances key drug candidates amidst financial growth

Zevra Therapeutics made significant strides in drug development and commercialization efforts in Q2 2024
Financially, the company raised substantial funds to support future operations and product launches
Challenges include managing expenses, FDA labeling discussions, and transitioning EAP patients for commercial launch
Opportunities lie in extending cash reserves, engaging stakeholders for successful product launches, and upcoming catalysts in 2024

Zevra Therapeutics excels with MIPLYFFA launch amidst financial challenges

Zevra Therapeutics showcased strong performance in Q3 2024, marked by the successful launch of MIPLYFFA and strategic updates on pipeline assets, despite financial losses and challenges with the OLPRUVA launch.
The company's proactive approach to market assessments, strategic planning, and commitment to research and development highlight its resilience and potential for future growth.
While facing challenges in patient awareness, reimbursement, and financial performance, Zevra remains focused on leveraging opportunities for market exclusivity, growth, and innovation in the biopharmaceutical sector.

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Zevra Therapeutics, Inc. is a commercial-stage rare disease company that combines science, data and patient needs to create therapies for diseases with limited or no treatment options. The firm focuses on the treatment of rare neurological and sleep conditions such as certain Urea Cycle Disorders, Niemann Pick Disease Type C and Idiopathic Hypersomnia. The company receives royalties for AZSTARYS from its commercial partner Corium. The company was founded by Christal M. M. Mickle and Travis C. Mickle on October 30, 2006 and is headquartered in Celebration, FL.

MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra's specialty pharmacy for dispense

Zevra Therapeutics Announces U.S. Commercial Availability of MIPLYFFA™ (arimoclomol) for Treatment of Niemann-Pick Disease Type C

Zevra Therapeutics, Inc. (NASDAQ:ZVRA ) Q3 2024 Earnings Conference Call November 12, 2024 4:30 PM ET Company Participants Nichol Ochsner - VP, IR & Corporate Communications Neil McFarlane - President & CEO LaDuane Clifton - CFO Joshua Schafer - Chief Commercial Officer & EVP, Business Development Conference Call Participants Jason Butler - JMP Securities Louise Chen - Cantor Fitzgerald Samantha Corwin - William Blair Eddie Hickman - Guggenheim Securities Sumant Kulkarni - Canaccord Genuity Oren Livnat - H.C. Wainwright Operator Good afternoon, and thank you for joining Zevra Therapeutics Third Quarter Financial Results and Corporate Update Conference Call.

Zevra Therapeutics, Inc. (ZVRA) Q3 2024 Earnings Call Transcript

Zevra Therapeutics (ZVRA) came out with a quarterly loss of $0.69 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.40 per share a year ago.

Zevra Therapeutics (ZVRA) Reports Q3 Loss, Lags Revenue Estimates

Data show that the NPCCSS swallow score reflects the patient's level of dysfunction Study indicates that a change in score reflects actual improvement or worsening in a patient's swallowing function CELEBRATION, Fla., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases, today announced that Elizabeth Berry-Kravis, M.D.

Zevra Therapeutics to Present Data Demonstrating Relevance of Swallow Domain in Niemann-Pick Disease Type C Clinical Severity Scale at 53rd Child Neurology Society Annual Meeting

CELEBRATION, Fla., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases, today announced that Neil F. McFarlane, President and Chief Executive Office of Zevra, will participate in a fireside chat at the Guggenheim Securities Healthcare Innovation Conference Virtual on Wednesday, Nov. 13, 2024, at 4 p.m. ET. Additionally, management will be available for one-on-one meetings with registered attendees.

Zevra Therapeutics to Participate at the Guggenheim Securities Healthcare Innovation Conference on Wed, Nov. 13

CELEBRATION, Fla., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases, today announced it will report third quarter financial results and provide a corporate update on Tuesday, Nov. 12, 2024.

Zevra Therapeutics to Report Third Quarter 2024 Financial Results and Provide Corporate Update on Nov. 12, 2024

Zevra Therapeutics (ZVRA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Zevra Therapeutics (ZVRA) Q3 Earnings Expected to Decline

CELEBRATION, Fla., Oct. 10, 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 Office of Zevra, will participate in a Rare Disease Panel at the 2024 Maxim Healthcare Virtual Summit, presented by Maxim Group LLC on Thursday, October 17, 2024 at 2 p.m. ET.

Zevra Therapeutics to Participate in Rare Disease Panel at the 2024 Maxim Healthcare Virtual Summit, Presented by Maxim Group LLC

The FDA approval for ZVRA's Miplyffa (arimoclomol) capsules in September for treating Niemann-Pick disease type C drives the stock.

Zevra Stock Surges Close to 70% in 3 Months: Here's Why

Zevra Therapeutics (ZVRA) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Zevra Therapeutics (ZVRA) Moves 9.1% Higher: Will This Strength Last?

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., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a commercial-stage rare disease therapeutics company, today announced that Rene Braeckman, Ph.D.

Zevra Therapeutics to Present Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at Sleep Europe 2024

MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive neurodegenerative disease

Zevra Therapeutics' MIPLYFFA™ (arimoclomol) Receives U.S. FDA Approval as Treatment for Niemann-Pick Disease Type C

The U.S. Food and Drug Administration approved Zevra Therapeutics' drug for a rare and fatal genetic disorder, the first treatment to get a nod for the condition, the health regulator said on Friday.

US FDA approves Zevra's genetic disorder treatment

New clinical efficacy and safety data for arimoclomol as a possible treatment for Niemann-Pick disease type C, including from long-term and real-world settings, demonstrate clinically meaningful reduction in disease progression

Zevra Therapeutics Presented New Data for Arimoclomol and OLPRUVA® (Sodium Phenylbutyrate) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium

CELEBRATION, Fla., Aug. 29, 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 Office of Zevra, will present at upcoming investor conferences during the month of September 2024. Additionally, management will be available for one-on-one meetings with registered attendees at each conference.

Zevra Therapeutics to Participate at Upcoming Investor Conferences

Zevra Therapeutics, Inc. (NASDAQ:ZVRA ) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Oschner - Vice President of Investor Relations and Corporate Communications Neil McFarlane - President and Chief Executive Officer LaDuane Clifton - Chief Financial Officer Josh Schafer - Chief Commercial Officer and Executive Vice President of Business Development Conference Call Participants Louise Chen - Cantor Fitzgerald Tim Lugo - William Blair Oren Livnat - H.C. Wainwright Operator Hello, and thank you for joining the Zevra Therapeutics Q2 2024 Financial Results and Corporate Highlights Call.

Zevra Therapeutics, Inc. (ZVRA) Q2 2024 Earnings Call Transcript

Zevra Therapeutics (ZVRA) came out with a quarterly loss of $0.48 per share versus the Zacks Consensus Estimate of a loss of $0.47. This compares to loss of $0.15 per share a year ago.

Zevra Therapeutics (ZVRA) Reports Q2 Loss, Tops Revenue Estimates

CELEBRATION, Fla., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (Nasdaq: ZVRA), a rare disease therapeutics company (“Zevra”), today announced the pricing of an underwritten public offering of 9,230,770 shares of its common stock at an offering price of $6.50 per share, for total gross proceeds of approximately $60.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Zevra. All of the common stock is being offered by Zevra. The offering is expected to close on August 12, 2024, subject to customary closing conditions. In addition, Zevra has granted the underwriters a 30-day option to purchase up to an additional 1,384,615 shares of its common stock at the public offering price, less underwriting discounts and commissions.

Zevra Therapeutics Announces Pricing of Underwritten Offering of Common Stock

CELEBRATION, Fla., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (Nasdaq: ZVRA), a rare disease therapeutics company (“Zevra”), today announced the commencement of a proposed underwritten public offering of its common stock. All shares of common stock to be sold in the proposed offering will be sold by Zevra. Zevra also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Zevra Therapeutics Announces Proposed Public Offering of Common Stock

CELEBRATION, Fla., Aug. 07, 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 Canaccord Genuity's 44th Annual Growth Conference in Boston, MA, on Wednesday, August 14, 2024, at 10:30 a.m. ET. Members of the executive team will be available for one-on-one investor meetings with registered attendees throughout the conference.

Zevra Therapeutics to Present at Canaccord Genuity's 44th Annual Growth Conference

Earnings Preview: Zevra Therapeutics (ZVRA) Q2 Earnings Expected to Decline

CELEBRATION, Fla., Aug. 02, 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) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with Niemann-Pick disease type C (NPC).

FDA Advisory Committee Votes Favorably that the Data Support Arimoclomol as Effective Treatment for Patients with Niemann-Pick Disease Type C

CELEBRATION, Fla., July 30, 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 audio webcast on Tuesday, August 13, 2024, at 4:30 p.m.

Zevra Therapeutics to Report Second Quarter 2024 Financial Results

The FDA will meet with its Genetic Metabolic Diseases Advisory Committee to review Zevra's (ZVRA) new drug application for pipeline candidate arimoclomol. Shares of Zevra gains on the news.

Zevra (ZVRA) Rises on Update on Niemann-Pick Disease Type C Drug

Zevra Therapeutics (ZVRA) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

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