Recent 8-K filings for ZVRA
Highest-materiality recent filing
Zevra Therapeutics' MIPLYFFA receives FDA approval as first treatment for Niemann-Pick disease type C
- FDA approved MIPLYFFA (arimoclomol) for NPC in adult and pediatric patients 2 years+; first FDA-approved NPC treatment.
- MIPLYFFA is indicated for use in combination with miglustat for neurological manifestations of NPC.
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Zevra Q1 2026 net revenue $36.2M (+78% YoY); net income $37.9M; cash $236.8M after debt repayment
MIPLYFFA net revenue $24.6M; total net revenue $36.2M vs $20.4M in Q1 2025.
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Zevra sells SDX portfolio to Commave for $50M, settles lawsuit, repays $63M debt
Total purchase price $50M; $25M at signing, $20M within 10 business days, $5M after records delivery.
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Zevra reports Q4 net revenue $34.1M, net income $12.2M; appoints Justin Renz as CFO
Q4 2025 net revenue $34.1M (+31% QoQ); net income $12.2M ($0.19 diluted EPS) vs. $(35.7)M loss in Q4 2024.
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Zevra appoints Timothy Sangiovanni as interim CFO effective Jan 1, 2026
Timothy Sangiovanni named interim principal financial officer, effective January 1, 2026.
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Zevra appoints Alicia Secor to board; director Wendy Dixon retires
Director Wendy Dixon resigned effective Dec 2, 2025; no disagreement with company operations.
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Zevra Therapeutics CFO R. LaDuane Clifton resigns effective Dec 31, 2025
CFO Clifton to depart Dec 31, 2025 to pursue other professional opportunities.
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Zevra Q3 net loss narrows to $0.5M; revenue jumps to $26.1M on MIPLYFFA sales
Q3 net revenue $26.1M (vs $3.7M YoY), with MIPLYFFA contributing $22.4M.
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Zevra Q2 net revenue $25.9M, net income $74.7M on PRV sale; adjusted net loss $3.2M
Product net revenue $21.8M (MIPLYFFA $21.5M, OLPRUVA $0.3M) vs $4.4M total revenue in Q2 2024.
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Zevra Therapeutics stockholders elect Dixon and Favorito as Class I directors
Wendy Dixon elected with 25.8M for (9.1M withheld); Tamara Favorito with 25.6M for (9.3M withheld). Broker non-votes ~9.65M.
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Zevra Q1 net revenue $20.4M, PRV sale nets $148M; net loss narrows to $3.1M
Q1 2025 net revenue $20.4M (up from $3.4M YoY); MIPLYFFA contributed $17.1M, OLPRUVA $0.1M.
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Zevra closes $150M sale of rare pediatric disease PRV, boosting cash to ~$217M
Closed sale of Rare Pediatric Disease Priority Review Voucher for $150M gross proceeds on April 1, 2025.
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Zevra Therapeutics reports FY 2024 net loss of $105.5M; sells PRV for $150M, cash runway into 2029
FY 2024 net revenue $23.6M (record Q4 product revenue $10.2M from MIPLYFFA); net loss ($105.5M) vs ($46.0M) in 2023.
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Zevra sells PRV for $150M cash; funds MIPLYFFA & OLPRUVA launches
Gross proceeds of $150M, payable in cash at closing; expected within 30-45 days.
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Zevra Therapeutics Announces Departure of Chief Development Officer and Chief Scientific Officer
Christal Mickle, Chief Development Officer and Co-Founder, notified of departure effective Dec. 6, 2024.
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Zevra launches MIPLYFFA for NPC; early adoption ahead of expectations
MIPLYFFA (arimoclomol) commercially available at Zevra's specialty pharmacy; first FDA-approved NPC treatment.
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Zevra Q3 net loss $33.2M; FDA approval of MIPLYFFA for NPC marks key milestone
Net loss of $33.2M ($0.69 per share) vs. $10.4M loss in Q3 2023; revenue $3.7M from French EAP and AZSTARYS royalties.
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FDA approved MIPLYFFA (arimoclomol) for NPC in adult and pediatric patients 2 years+; first FDA-approved NPC treatment.
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Zevra Q2 revenue falls to $4.4M, net loss $19.9M; FDA decision on arimoclomol by Sept 21
Net revenue $4.4M vs $8.5M YoY; net loss $19.9M ($0.48/share) vs $2.6M ($0.08/share) in Q2 2023.
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Zevra Therapeutics prices $60M common stock offering at $6.50/share; net proceeds ~$56.1M
9,230,770 shares sold at $6.50; underwriters have 30-day option for 1,384,615 additional shares.
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Revenue for Q2 2024 expected between $4.2M and $4.6M, down from $8.47M in Q2 2023 which included a $5.0M milestone payment from AZSTARYS license.
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FDA panel votes 11-5 that Zevra's arimoclomol is effective for NPC; PDUFA date Sep 21
FDA GeMDAC voted 11 yes, 5 no that data support arimoclomol as effective for Niemann-Pick disease type C.
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ATM facility allows sale of up to $75M in common stock at company's discretion.
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Zevra announces FDA advisory committee meeting for arimoclomol on Aug 2, 2024
FDA's Genetic Metabolic Diseases Advisory Committee (GeMDAC) will review arimoclomol NDA for Niemann-Pick disease type C.
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Zevra reports positive Phase 2 trial results for KP1077 in idiopathic hypersomnia
KP1077 well-tolerated at up to 320 mg/day; AEs similar to methylphenidate, mostly mild (insomnia, headache, anxiety).
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Zevra Therapeutics shareholders reject amendments to 2014 Equity Incentive Plan at annual meeting
Three Class III directors elected: Thomas D. Anderson, Neil F. McFarlane, Alvin Shih, M.D.
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Zevra Q1 net loss $16.6M; OLPRUVA launch with 4 patients, cash runway into 2026
Net loss of $16.6M ($0.40 loss per share) compared to $13.2M loss in Q1 2023.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.75 · Most common event earnings