Zevra Therapeutics Inc

Earnings data Q1 2024

Zevra reports strong Q1 results, focuses on rare disease therapeutics

Zevra's Q1 performance showcased financial strength but also highlighted challenges in net loss and prescription trends. The company's strengths lie in its focus on rare disease therapeutics, leadership continuity, and commitment to clear communication. Opportunities exist in the company's rebranding, collaborations, and promising therapeutic advancements.

ZVRA Therapeutics reports strong Q2 performance and advances pipeline

ZVRA Therapeutics demonstrated robust financial performance, with a strong cash position and significant sales milestones for AZSTARYS. The progress in the pipeline and upcoming data releases offer promising growth prospects, but the company must address FDA recommendations and sustain sales momentum.

Zevra Therapeutics reports Q3 revenue of $2.9M, arimoclomol NDA resubmission expected

Zevra Therapeutics is making strides in delivering therapeutic candidates for rare diseases, with arimoclomol's potential approval for NPC treatment. However, the company faces financial challenges with increased R&D expenses and a net loss for Q3 2023. The proposed acquisition of Acer and the commercial launch of arimoclomol present significant opportunities for the company.

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Zevra Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company, which engages in the discovery and development of proprietary prodrugs. It focuses on the treatment of serious medical conditions such as attention deficit hyperactivity disorder, pain, and other central nervous system disorders through its platform technology known as Ligand Activated Therapy. The company was founded by Christal M. M. Mickle and Travis C. Mickle on October 30, 2006 and is headquartered in Celebration, FL.

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

NEW YORK , April 12, 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., 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

CELEBRATION, Fla., Feb. 28, 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 upcoming investor conferences in March 2024. Additionally, management will be available for one-on-one meetings with registered attendees at each of the conferences.

Zevra Therapeutics to Participate at Upcoming Investor Conferences

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.

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

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