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

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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.

KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported assessments of daytime sleepiness, sleep inertia, and brain fog

Zevra Therapeutics Announces Positive Final Results from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia at SLEEP 2024 Annual Meeting

Zevra Therapeutics, Inc. (NASDAQ:ZVRA ) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Nichol Ochsner - VP, Investor Relations & Corporate Communications Neil Mcfarlane - President, CEO & Director LaDuane Clifton - CFO, Treasurer, Secretary Josh Schafer - Chief Commercial Officer & EVP, Business Development Adrian Quartel - Chief Medical Officer Conference Call Participants Tim Lugo - William Blair & Company Jonathan Aschoff - ROTH MKM Louise Chen - Cantor Fitzgerald Oren Livnat - H.C. Wainwright & Co. Kyle Qian - Canaccord Genuity Operator Good morning, everyone.

Zevra Therapeutics, Inc. (ZVRA) Q1 2024 Earnings Call Transcript

Zevra Therapeutics (ZVRA) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.49. This compares to loss of $0.34 per share a year ago.

Zevra Therapeutics (ZVRA) Reports Q1 Loss, Lags Revenue Estimates

Full commercial launch of OLPRUVA at the end of January 2024, with market access growing to ~ 75% of covered lives as of May 1, 2024

Zevra Therapeutics Reports First Quarter 2024 Financial Results and Corporate Updates

NEW YORK , May 6, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Zevra Therapeutics, Inc. ("Zevra" or the "Company") (NASDAQ: ZVRA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Zevra Therapeutics, Inc. - ZVRA

CELEBRATION, Fla., May 01, 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 Wednesday, May 8, 2024, at 8:00 a.m. ET, to review its corporate and financial results for the first quarter of 2024.

Zevra Therapeutics to Report First Quarter 2024 Results on May 8, 2024

CELEBRATION, Fla., April 29, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that Neil F. McFarlane, Zevra's President and Chief Executive Officer, has issued a Letter to Stockholders providing a review of key accomplishments and outlook for 2024.

Zevra Therapeutics' President and Chief Executive Officer Issues Letter to Stockholders Highlighting Recent Key Accomplishments and Outlook for 2024

The oral presentation highlighted data from Zevra's Expanded Access Program demonstrating a consistent safety profile

Zevra Therapeutics Presents New Data on the Long-Term Safety and Efficacy of Arimoclomol as a Treatment for Niemann-Pick Disease Type C at the SIMD 45th Annual Meeting

CELEBRATION, Fla., April 10, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that it has entered into a new credit facility provided by leading biotech investors. Led by Perceptive Advisors and Healthcare Royalty, the new credit facility provides up to $100M in committed capital in three tranches: an initial draw of $60M at closing, a second tranche of up to $20M available until October 5, 2025, and a third tranche of up to $20M which becomes available upon approval of arimoclomol, the Company's product candidate for the treatment of Niemann Pick disease Type C (NPC), in each case subject to certain terms and conditions. As part of this transaction, the Company has retired its combined existing debt of approximately $43.1M.

Zevra Therapeutics Refinances Existing Debt with up to $100M in Committed Capital under New Credit Facility

Zevra Therapeutics, Inc. (ZVRA) Q4 2023 Earnings Call Transcript

Launch of OLPRUVA® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M Conference call scheduled for today, March 28, 2024, at 4:30 p.m. ET  CELEBRATION, Fla.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH).

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

CELEBRATION, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that it will participate in the upcoming 23rd Annual Needham Virtual Healthcare Conference being held virtually on April 8-9, 2024. The Company's presentation will take place on Monday, April 8, 2024, at 3:45 p.m. ET. Additionally, members of Zevra's management team will be available for one-on-one investor meetings with registered attendees throughout the conference.

Zevra Therapeutics to Present at the 23rd Annual Needham Virtual Healthcare Conference

Zevra Therapeutics, Inc. (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.

Will Zevra Therapeutics (ZVRA) Report Negative Earnings Next Week? What You Should Know

CELEBRATION, Fla., March 18, 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 live audio webcast on Thursday, March 28, 2024, at 4:30 p.m. ET, to review its corporate and financial results for the fourth quarter and full year 2023.

Zevra Therapeutics to Report 2023 Fourth Quarter and Full Year Financial Results on March 28, 2024

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is September 21, 2024 CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC).

Zevra Therapeutics Provides FDA Update on the PDUFA Action Date for Arimoclomol as a Treatment for Niemann-Pick Disease Type C

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) Soars 6.6%: Is Further Upside Left in the Stock?

CELEBRATION, Fla., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that it will present at the upcoming Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually on Tuesday, February 13, 2024, at 9:20 a.m. ET. Additionally, members of Zevra's management team will be available for one-on-one investor meetings with registered attendees during the conference from February 13-14, 2024.

Zevra Therapeutics to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference

CELEBRATION, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointment of Alvin Shih, MD, MBA, to the Company's Board of Directors (Board) effective as of January 20, 2024. Dr. Shih has extensive experience in biotechnology leadership and rare disease therapeutics development and currently serves as President and CEO of Catamaran Bio, a biotechnology company developing cell therapies for multiple oncologic indications.

Zevra Therapeutics Appoints Experienced Biopharma Executive Alvin Shih, MD, MBA, to the Board of Directors

Arimoclomol NDA has been assigned a PDUFA action date of June 21, 2024 CELEBRATION, Fla., Jan. 08, 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) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class treatment for Niemann-Pick disease type C.

Zevra Therapeutics Receives FDA Acceptance of Resubmission of NDA for Arimoclomol as a Treatment for Niemann-Pick Disease Type C

CELEBRATION, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the appointment of Adrian Quartel, M.D., FFPM, as Chief Medical Officer. Dr. Quartel brings more than 20 years of experience in the international pharmaceutical industry with senior roles in clinical development, pharmacovigilance and medical affairs.

Zevra Therapeutics Appoints Global Medical Leader, Adrian Quartel, M.D., FFPM, as Chief Medical Officer

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.

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