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.

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, an acknowledgment letter from the FDA that the resubmission is complete and setting the PDUFA date is expected within 30 days. Zevra expects the NDA to be classified as a Class II submission which would be subject to a review period by the FDA within six months from the date of submission.

Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration

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. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the completion of its acquisition of Acer Therapeutics Inc. (Acer) which marks a significant step forward in executing Zevra's strategy to become a leader in developing and commercializing treatments for rare diseases and furthers the Company's commitment to supporting patient communities with limited or no existing therapeutic options.

Zevra Therapeutics Completes Acquisition of Acer Therapeutics in its Journey to Become a Leading Rare Disease Company

Zevra Therapeutics, Inc. (NASDAQ:ZVRA ) Q3 2023 Earnings Conference Call November 7, 2023 8:00 AM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Neil McFarlane - President and Chief Executive Officer Christal Mickle - Co-Founder and Chief Product Development Officer LaDuane Clifton - Chief Financial Officer, Secretary and Treasurer Joshua Schafer - Chief Commercial Officer and Executive Vice President, Business Development Conference Call Participants Louise Chen - Cantor Fitzgerald Jonathan Aschoff - ROTH MKM Sumant Kulkarni - Canaccord Oren Livnat - H.C. Wainwright Operator Good morning, everyone.

Zevra Therapeutics, Inc. (ZVRA) Q3 2023 Earnings Call Transcript

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 scheduled for today, Nov 7, 2023, 8:00 a.m.

Zevra Therapeutics Reports Corporate Updates and Third Quarter 2023 Financial Results

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.

Zevra Therapeutics to Report Third Quarter 2023 Results on November 7, 2023, at 8:00 a.m. ET

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 essential support for people living with Niemann-Pick disease type C (NPC) and their families and advocate for needed treatments.

Zevra Therapeutics Celebrates and Supports Global Niemann-Pick Disease Awareness Day on October 19th and Niemann-Pick Disease Awareness Month Throughout October

Acer Therapeutics

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Acer Therapeutics Inc. (NasdaqCM: ACER) to Zevra Therapeutics, Inc. (NasdaqGS: ZVRA). Under the terms of the proposed transaction, shareholders of Acer will receive 0.121 shares of Zevra for each share of Acer that they own. Additionally, Acer stockholders would receive non-transferable Contingent Value Rights.

ACER THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Acer Therapeutics Inc. - ACER

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.

Zevra Therapeutics Appoints Neil F. McFarlane as President, Chief Executive Officer and Director

Presentation to focus on the arimoclomol program for the treatment of Niemann-Pick Disease type C and related early access programs

Zevra Therapeutics to Present at the 52nd Child Neurology Society Annual Meeting

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

Zevra Therapeutics Announces Interim Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

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 registered attendees during the conference.

Zevra Therapeutics to Participate in the Cantor Global Healthcare Conference

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 hypersomnia (IH), at the Psych Congress 2023 taking place September 6-10, 2023, in Nashville, Tennessee.

Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023

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 25th 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 registered attendees during the conference from September 11-13, 2023.

Zevra Therapeutics to Participate in the H.C. Wainwright 25th Annual Global Investment Conference

Zevra's acquisition of Acer Therapeutics adds significant value to its rare disease-focused strategy. Acer's newly launched product, Olpruva, aligns with Zevra's potential commercial efforts with arimoclomol in targeting rare diseases. Acer's Phase 3 trial for vascular Ehlers-Danlos syndrome fills an unmet need in the market and adds to Zevra's late-stage pipeline.

Zevra's Rare Find: Unearthing Value In Niche Rare Diseases The Market Overlooks

The consensus price target hints at a 248.5% upside potential for Zevra Therapeutics (ZVRA). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

How Much Upside is Left in Zevra Therapeutics (ZVRA)? Wall Street Analysts Think 248.51%

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 Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio and Adding Commercial Product

Zevra Therapeutics, Inc. (NASDAQ:ZVRA ) Q2 2023 Results Conference Call August 14, 2023 8:30 AM ET Company Participants Nichol Ochsner - Vice President of Investor Relations Christal Mickle - Co-Founder, Chief Product Development Officer and Interim CEO LaDuane Clifton - Chief Financial Officer Josh Schafer - Chief Commercial Officer and Executive Vice President, Business Development Conference Call Participants Oren Livnat - H.C. Wainwright Sumant Kulkarni - Canaccord Jonathan Aschoff - ROTH MKM Operator Good morning, and welcome to the Zevra Therapeutics Second Quarter 2023 Corporate and Financial Results Conference Call.

Zevra Therapeutics, Inc. (ZVRA) Q2 2023 Earnings Call Transcript

The mean of analysts' price targets for Zevra Therapeutics (ZVRA) points to a 227.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Can Zevra Therapeutics (ZVRA) Climb 227.55% to Reach the Level Wall Street Analysts Expect?

Completed collaborative and productive pre-submission meeting with FDA for arimoclomol NDA in August 2023; filing expected in Q4 2023

Zevra Therapeutics Reports Corporate Updates and Second Quarter 2023 Financial Results

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 retirement of board member Matthew R. Plooster, whose valuable leadership has played a crucial role in shaping Zevra's growth. Both the announcement of the new director and Mr. Plooster's retirement are in accordance with the plan announced by the Company on May 8, 2023.

Zevra Therapeutics Appoints Thomas Anderson to Board of Directors and Announces Retirement of Matthew R. Plooster

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.

Zevra Therapeutics to Report Second Quarter 2023 Results on August 14, 2023

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 July 22, 2023.

Zevra Therapeutics to Participate in the 2023 NNPDF Family Support and Medical Conference

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 effective after the U.S. market opens on Monday, June 26, 2023.

Zevra Therapeutics to be Added to Russell 2000® and Russell 3000® Indexes Effective June 26, 2023

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 Therapeutics to Participate in the Healthcare Virtual Conference Presented by Maxim Group LLC and hosted by M-Vest

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.

Zevra Therapeutics Presents Design of Phase 2 Clinical Trial Investigating KP1077 for the Treatment of Idiopathic Hypersomnia (IH) at Beyond Sleepy 2023

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