MIPLYFFA, the first FDA-approved treatment for Niemann-Pick disease type C, is available at Zevra's specialty pharmacy for dispense AmplifyAssist™, Zevra's comprehensive patient support program, in place to address access barriers CELEBRATION, Fla., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that MIPLYFFA™ (MY-PLY-FAH) (arimoclomol), the first treatment approved by the U.S. Food and Drug Administration (FDA) for the treatment of Nieman Pick disease type C (NPC), is now commercially available for dispense. MIPLYFFA is indicated for use in combination with miglus

FDA approval of MIPLYFFA™ and product launch cap third quarter filled with multiple commercial and clinical development milestones Zevra received rare pediatric disease Priority Review Voucher Company ends quarter with cash, cash equivalents and investments of $95.5 million Company to host conference call and webcast today, Nov. 12, 2024, 4:30 p.m. ET CELEBRATION, Fla., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases, today reported its financial results for the t

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. (NASDAQ: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., Ph.D., Professor of Pediatrics, Neurological Sciences, and Biochemistry at Rush University Medical Center in Chicago, is presenting data demonstrating the relevance of the swallow domain as part of the Niemann-Pick disease T

CELEBRATION, Fla., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The live webcast will be accessible via "Events & Presentations" on the Investor Relations section of Zevra's website at investors.zevra.com. About Zevr

CELEBRATION, Fla., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The Company will issue a news release after the market closes and host a conference call/audio webcast at 4:30 p.m. ET that day. The corporate update will include recent progress with the commercial launches of MIPLYFFA™ and OLPRUVA® as well as the Company's clinical stage programs. A link to the audio webcast will be accessible on the "Events & Presentations"

CELEBRATION, Fla., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. Maxim Group 2024 Annual Healthcare Conference Rare Disease Panel on Thursday, October 17, 2024, at 2:00 p.m. ET. This conference will be live on M-Vest. To attend, investors can register and watch the company discussion on the M-Vest page. The archived presentation will also be accessible und

PASADENA, Calif. and CELEBRATION, Fla., Oct. 09, 2024 (GLOBE NEWSWIRE) -- The National Urea Cycle Disorders Foundation (NUCDF) and Zevra Therapeutics, Inc. (NASDAQ:ZVRA) are teaming up to launch an awareness campaign during the month of October to improve the diagnosis of urea cycle disorders (UCDs). Their goal is to highlight the critical importance of promptly checking blood ammonia levels and using proper testing techniques. A blood ammonia test is essential to uncover elevated ammonia levels (hyperammonemia), the classic sign of a urea cycle disorder. Resources on recognizing and testing for hyperammonemia are featured on the campaign website, checkammonia.com. Quickly diagnosing UCD

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. (NASDAQ:ZVRA) (Zevra, or the Company) a commercial-stage rare disease therapeutics company, today announced that Rene Braeckman, Ph.D., Zevra's Senior Vice President of Clinical Development, will present top-line data from the placebo-controlled, double-blind, randomized withdrawal Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH) at Sleep

MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive neurodegenerative disease MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adults and pediatric patients 2 years of age and older Zevra receives rare pediatric disease priority review voucher in conjunction with approval Company launches AmplifyAssist™ patient support program Conference call and webcast set for 8:00 a.m. EDT on Monday, Sept. 23, 2024 CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a commercial-stage rare disease therap

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 Arimoclomol was well tolerated during the Open Label Extension trial and Early Access Program with no safety signals identified PK modeling studies showed that administration of OLPRUVA while fasting vs fed results in higher drug exposure which may allow for lower effective dosages when taken without food CELEBRATION, Fla., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today

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CELEBRATION, Fla., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The Company will issue a news release after the market closes and host a conference call/audio webcast at 4:30 p.m. ET that day. The corporate update will include recent progress with the commercial launches of MIPLYFFA™ and OLPRUVA® as well as the Company's clinical stage programs. A link to the audio webcast will be accessible on the "Events & Presentations"

MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive neurodegenerative disease MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adults and pediatric patients 2 years of age and older Zevra receives rare pediatric disease priority review voucher in conjunction with approval Company launches AmplifyAssist™ patient support program Conference call and webcast set for 8:00 a.m. EDT on Monday, Sept. 23, 2024 CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a commercial-stage rare disease therap

CELEBRATION, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. ET, to review its corporate and financial results for the second quarter of 2024. The link to the audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by conference call, use the dial-in information below. (800) 225-9448 (U.S.)+1 (203) 518- 9708 (International)Conference ID: ZVRAQ224 An archive of the webcast will be available for 90 da

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 Arimoclomol NDA review underway with PDUFA date of September 21, 2024 Reported positive topline results from KP1077 Phase 2 Trial in idiopathic hypersomnia, with full data to be presented at SLEEP 2024 in early June 2024 Conference call scheduled for today, May 8, 2024, at 8:00 a.m. ET         CELEBRATION, Fla., May 08, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the first quarter ended March 31, 2024. 

CELEBRATION, Fla., May 01, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The link to the audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by conference call, use the dial-in information below. 800-343-5419 (U.S.)+1 203-518-9731 (International)Conference ID: ZVRAQ124 An archive of the webcast wil

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., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.  "We made solid progress on our key priorities in 2023," said Neil F. McFarlane, President and Chief Executive Officer of Zevra. "As we look to 2

CELEBRATION, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The link to the audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by conference call, use the dial-in information below. (800) 245-3047 (U.S.)+1 (203) 518-9765 (International)Conference ID: ZVRAQ423 An archive of the webcast will be ava

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. ET  CELEBRATION, Fla., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corpo

CELEBRATION, Fla., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NASDAQ: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. The link to audio webcast will be accessible via the Investor Relations section of the Company's website, https://investors.zevra.com/. To join the meeting by conference call, use the dial-in information below. (800) 343-4849 (U.S.)+1 (203) 518-9843 (International)Conference ID: ZVRAQ323 An archive of the webcast will be available f

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 to assume commercialization efforts of OLPRUVA™, recently approved for the treatment of urea cycle disorders (UCDs) FDA-approved commercial asset expected to increase and diversify Zevra's revenues OLPRUVA™ commercial operations provide Zevra scale and cost synergies to complement the potential launch of arimoclomol Adds EDSIVO™, a Phase 3 program for vascular Ehlers-Danlos Syndrome (vEDS), to Zevra's rare disease clinical pipeline Zevra to discuss details during conference call today, at 8:30 a.m. ET CELEBRATION, F

This whale alert can help traders discover the next big trading opportunities. Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner. Traders often look for circumstances when the market estimation of an option diverges away from its normal worth. Abnormal amounts of trading activity could push option prices to hyperbolic or underperforming levels. Here's the list of options activity happening in today's session: Symbol PUT/CALL Trade Type Sentiment Exp. Date Strike Price Total Trade Price Open Interest Volume BSX PUT SWEEP BEARISH 08/16/24 $75.00 $68.9K 5.5K 2.1K MRNA CALL SWEEP NEUTRAL 11/15/24 $170.00 $121.

Although U.S. stocks closed mixed on Wednesday, there were a few notable insider trades. When insiders purchase shares, it indicates their confidence in the company’s prospects or that they view the stock as a bargain. Either way, this signals an opportunity to go long on the stock. Insider purchases should not be taken as the only indicator for making an investment or trading decision. At best, it can lend conviction to a buying decision. Below is a look at a few recent notable insider purchases. For more, check out Benzinga’s insider transactions platform. Zevra Therapeutics The Trade: Zevra Therapeutics, Inc. (NASDAQ:ZVRA) CFO & Treasurer R. Laduane Clifton acquired a total o

Although U.S. stocks closed higher on Tuesday, there were a few notable insider trades. When insiders purchase shares, it indicates their confidence in the company’s prospects or that they view the stock as a bargain. Either way, this signals an opportunity to go long on the stock. Insider purchases should not be taken as the only indicator for making an investment or trading decision. At best, it can lend conviction to a buying decision. Below is a look at a few recent notable insider purchases. For more, check out Benzinga’s insider transactions platform. Barnes & Noble Education The Trade: Barnes & Noble Education, Inc. (NYSE:BNED) Director Eric Singer acquired a total of 18,

The FDA will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2 to review the marketing application for Zevra Therapeutics Inc.’s (NASDAQ:ZVRA) arimoclomol for Niemann-Pick disease type C (NPC). The application for arimoclomol has been assigned a Prescription Drug User Fee Act (PDUFA) action date of September 21, which was extended from June 21. Previously known as KemPharm, Zevra Therapeutics acquired arimoclomol from Orphazyme for $12.8 million.  In 2021, the FDA issued a complete response letter to arimoclomol as a treatment option for Niemann-Pick disease type C. The CRL asked for additional qualitative and quantitati

HC Wainwright & Co. analyst Oren Livnat reiterates Zevra Therapeutics (NASDAQ:ZVRA) with a Buy and maintains $15 price target.

Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has indicated that it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Committee (GeMDAC) on August 2, 2024, to review the New Drug Application (NDA) for arimoclomol as an orally delivered, first-in-class treatment for Niemann-Pick disease type C (NPC). According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days before the meeting. The GeMDAC consists of experts in the fields of medical genetics, inborn errors of met

Orsini Specialty Pharmacy (Orsini), and Zevra Therapeutics, Inc. (NASDAQ:ZVRA) (Zevra) today announced that Orsini is now the pharmacy partner for OLPRUVA® (sodium phenylbutyrate) for oral suspension. OLPRUVA® is a prescription medicine used along with certain therapies, including changes in diet, for long-term management of certain adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). Visit OLPRUVA-Prescribing-Information.pdf (olpruva.com) to view the full Prescribing Information, including Important Safety Information.

Zevra Therapeutics (NASDAQ:ZVRA) reported quarterly losses of $(0.40) per share which beat the analyst consensus estimate of $(0.48) by 16.67 percent. The company reported quarterly sales of $3.425 million which missed the analyst consensus estimate of $3.764 million by 8.99 percent. This is a 18.96 percent increase over sales of $2.879 million the same period last year.