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Zevra Therapeutics, Inc.

$13.35

-0.59 (-4.23%)

C 53Pipeline Score Fair Value Pharma · Commercial
Market Cap
592.92 M
EPS
2.18
P/E Ratio
4.66 $
Value Trade
17.35 M
SEC Financials
Q1 2026
  • Dilution Risk

    5%
  • Revenue

    36.22 M

  • R&D Expenses

    4.39 M

  • Operating CF

    6.14 M


  • Total Assets

    278.58 M

  • Total Liabilities

    72.78 M

  • Equity

    205.80 M

  • D/E Ratio

    12,345

-12.4 %
Week
-4.75 %
1 Month
13.85 %
3 Month
15.69 %
6 Month
0.4 %
5 Year
-94.66 %
All Time
Cash Data
Profitable
  • Cash Position

    200.62 M

  • Monthly Burn

    -

  • Runway

    12,345 mo

  • Burn Trend

    Decelerating
  • SEC Filing

    May 6, 2026
Overview
Volume
2.06 M
52 Week Range
7.16 - 13.16
% held by Insiders
1.35 %
% held by Institutions
71 %
Enterprise Value
393.46 M
Total Shares
59.09 M
Short %
11.56 %
Float Shares
56.14 M
Company Description
HQ: 101 FEDERAL STREET, BOSTON, MA...
Employees:61

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
Example Drug Treatment for example condition requiring FDA review
Phase 3
-%

FDA review of the new drug application for the treatment of example condition.

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Small Molecule
Oncology
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for Zevra Therapeutics, Inc.

250Total events
1Upcoming
95Tier-1 (high impact)
2015 – 2026Coverage

Upcoming catalysts 1

TBD
T2EU MAA Submission
Marketing Authorization Application submitted to EMA for arimoclomol
MIPLYFFANiemann-Pick disease type C (NPC)

Event history 249

Jun 23, 2026
PublicationMIPLYFFAPresentation
Publication of arimoclomol pediatric substudy results in Molecular Genetics and Metabolism Reports
Niemann-Pick disease type C (NPC)source ↗
May 6, 2026
Quarterly UpdateCorporate
Q1 2026 financial results reported
May 6, 2026
EU MAA SubmissionarimoclomolEx-US Regulatory
MAA under review by EMA for arimoclomol in NPC
Niemann-Pick disease type Csource ↗
May 6, 2026
Oral PresentationPresentation
Conference call and webcast to discuss Q1 2026 results
Q2 2026
FDA Feedback ReceivedceliprololFDA Meeting
Expects follow-up meeting with FDA in H2 2026 to explore accelerated development pathways
Vascular Ehlers-Danlos Syndromesource ↗
Mar 2026
Partnership / LicenseCorporate
Completed $50M sale of SDX portfolio to Commave Therapeutics
Mar 2026
Enrollment UpdateceliprololTrial
Enrolled 10 patients in Q1 2026, total 62 in Phase 3 DiSCOVER trial
Vascular Ehlers-Danlos Syndromesource ↗
Mar 16, 2026
Partnership / LicenseCorporate
Zevra sells SDX portfolio (AZSTARYS and KP1077) to Commave Therapeutics for $50 million
Mar 16, 2026
IP Litigation RulingIP / Competition
Zevra and Commave settle Delaware Chancery Court litigation
Mar 16, 2026
Debt Royalty FinancingCorporate
Zevra repays $63 million term loan in full
Mar 13, 2026
Poster PresentationarimoclomolPresentation
Poster presentation at Annual Clinical Genetics Meeting on March 13, 2026
Niemann-Pick disease type Csource ↗
Mar 9, 2026
Quarterly UpdateCorporate
Q4 and FY 2025 financial results reported
Drug Pipeline Intelligence
C53
Pipeline Score
$1.5B
Pipeline Value
Fair Value
Valuation Signal
5
Drugs Scored
2.5x
rNPV / MCap
Top 79%
Micro Cap
(rank 193 of 912)
Percentile Rank
Zevra Therapeutics, Inc. carries a moderate pipeline score (53/100), with $3.6B risk-adjusted pipeline value, led by KP415 in ADHD (Phase 3).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
KP415
Small molecule
ADHDPhase 3NCT0346065249% $2.9B COMPLETED 437 - -Jul 9, 2019 -Jul 19, 2021
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
MIPLYFFA
PriorityOrphanRare Pediatric
Niemann-Pick disease type C
Phase 2/3
2026-06-23

Arimoclomol was generally well tolerated, with no new safety signals, and pharmacokinetic results were consistent with older pediatric populations.

Read More

Zevra Therapeutics Announces Publication of Positive MIPLYFFA® Data from Pediatric Substudy in Infants with Niemann-Pick Disease Type C (NPC)

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MIPLYFFA
PriorityOrphanRare Pediatric
Niemann-Pick disease type C
Phase 2/3
2026-06-23

Arimoclomol was generally well tolerated, with no new safety signals, and pharmacokinetic results were consistent with older pediatric populations.

Read More

Zevra Therapeutics Announces Publication of Positive MIPLYFFA® Data from Pediatric Substudy in Infants with Niemann-Pick Disease Type C (NPC)

Read More
MIPLYFFA
PriorityOrphanRare Pediatric
Niemann-Pick disease type C
Phase 2/3
2026-06-23

Arimoclomol was generally well tolerated, with no new safety signals, and pharmacokinetic results were consistent with older pediatric populations.

Read More

Zevra Therapeutics Announces Publication of Positive MIPLYFFA® Data from Pediatric Substudy in Infants with Niemann-Pick Disease Type C (NPC)

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
ZVRA Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2027-02-19 0.00 0 - - - - - -
2027-02-19 0.00 0 - - - - - -
2027-02-19 0.00 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
ZVRA
Jun 23, 2026
ZVRAPhases

Zevra Therapeutics Announces Publication of Positive MIPLYFFA® Data from Pediatric Substudy in Infants with Niemann-Pick Disease Type C (NPC)

Zevra Therapeutics announced the publication of positive data from a pediatric substudy evaluating arimoclomol for Niemann-Pick disease type C (NPC) in infants. The study demonstrated that arimoclomol was generally well tolerated and provided preliminary evidence supporting its use in this age group. The findings contribute to the growing body of evidence for MIPLYFFA's effectiveness across different ages.

Read more →
ZVRA
Jun 22, 2026
ZVRAPhases

Arimoclomol in infants with Niemann-Pick disease type C: Results from the phase 2/3 open-label pediatric substudy

The article discusses the results of a phase 2/3 open-label pediatric substudy of Arimoclomol in infants diagnosed with Niemann-Pick disease type C. The findings suggest that Arimoclomol may provide therapeutic benefits for this rare condition. This study highlights the ongoing efforts to develop treatments for pediatric patients with challenging genetic disorders.

Read more →
ZVRA
May 6, 2026
ZVRAGeneral
▲ +6%on this news

Zevra Reports First Quarter 2026 Financial Results and Corporate Update Q1 2026 net revenue of $36.2 million, a 78% increase over Q1 2025 Completed $50.0 million sale of SDX portfolio to Commave Therapeutics Operational

Zevra Therapeutics reported a significant increase in net revenue, reaching $36.2 million for Q1 2026, reflecting a 78% growth compared to the same quarter in the previous year. The company also successfully divested its SDX portfolio for $50 million, resulting in a strengthened financial standing and a cash position of $236.8 million. Additionally, new patient enrollments for MIPLYFFA, their therapy for Niemann-Pick disease type C, indicate a stable market access and continued demand for the treatment. A conference call is scheduled for later today to discuss these results in detail.

Read more →
ZVRA
Apr 9, 2026
ZVRAGeneral

Analysis of NPC1 Genotypes: Findings From the US Arimoclomol Expanded Access Program for Niemann-Pick Disease Type C

The article discusses the findings from the US Arimoclomol Expanded Access Program related to NPC1 genotypes in patients with Niemann-Pick Disease Type C. It provides an overview of the program's objectives and the implications of the findings for treatment. However, specific results or conclusions from the analysis are not detailed in the text.

Read more →
ZVRA
Mar 16, 2026
ZVRAGeneral

Document Zevra Therapeutics Sells SDX Portfolio to Commave Therapeutics for $50 Million Companies Resolve Lawsuit in Delaware

Zevra Therapeutics has entered into a $50 million agreement with Commave Therapeutics for the sale of its serdexmethylphenidate portfolio, which includes the products AZSTARYS and KP1077. This transaction resolves a previous lawsuit initiated by Commave in 2024 against Zevra, highlighting a successful negotiation between the two companies. As part of the agreement, Zevra has also repaid a significant term loan, resulting in a debt-free status that enhances its financial flexibility. The company plans to continue its focus on rare diseases, reaffirming its commitment to patient-centric innovations.

Read more →
ZVRA
Mar 9, 2026
ZVRAGeneral

Zevra Reports Fourth Quarter and Full Year 2025 Financial Results Q4 net revenue of $34.1 million, representing 31% growth quarter-over-quarter FY 2025 net revenue of $106.5 million , driven by growth in MIPLYFFA net rev

Zevra Therapeutics, Inc. reported a robust financial performance for the fourth quarter and full year of 2025, highlighting a net revenue of $34.1 million for Q4, representing a 31% quarter-over-quarter growth. The company's total FY 2025 net revenue reached $106.5 million, primarily driven by strong sales of MIPLYFFA, which generated $87.4 million. The firm has also made strategic advancements in its operations, including relocating its headquarters to Boston and broadening access to its therapies through various programs. This positive trajectory reflects the company’s focus on addressing the needs of patients with rare diseases and creating shareholder value.

Read more →
ZVRA
Feb 25, 2026
ZVRAGeneral

Transpire Bio Strengthens its Leadership Team with Appointment of LaDuane Clifton as Chief Financial Officer

Transpire Bio Inc. has appointed R. LaDuane Clifton as Chief Financial Officer to enhance its leadership as it transitions from clinical to commercial stages. Clifton brings a wealth of experience in public finance and biopharmaceutical development. His appointment is seen as a strategic move to support the company's growth and corporate priorities.

Read more →
ZVRA
Feb 3, 2026
ZVRAPhases

Efficacy of Arimoclomol Combined With Miglustat at Months 3, 6, 9 and 12 of the Double-Blind, Randomized, Placebo-Controlled NPC002 Trial

The NPC002 trial evaluates the efficacy of Arimoclomol combined with Miglustat over 12 months. This double-blind, randomized, placebo-controlled study is set to present its findings at the 22nd Annual WORLDSymposium. The results may provide insights into effective treatments for patients.

Read more →
ZVRA
Feb 3, 2026
ZVRAConferences/Events

Long-term safety and effectiveness of arimoclomol adult and pediatricNiemann-Pick disease type C patients in the US early access program (EAP)

The article discusses the long-term safety and effectiveness of arimoclomol for adult and pediatric patients with Niemann-Pick disease type C. This evaluation is part of the US early access program and will be presented at the 22nd Annual WORLD Symposium in February 2026. The findings aim to provide valuable insights into the treatment's impact.

Read more →
ZVRA
Feb 3, 2026
ZVRAConferences/Events

Real-world safety and effectiveness arimoclomol in patients with NPC:outcomes from the US early access program (EAP) over a 4-year period

The article discusses the safety and effectiveness of arimoclomol in patients with Niemann-Pick disease type C (NPC) based on data from a US early access program over four years. The findings suggest that arimoclomol may offer significant benefits for these patients. The results were presented at the 22nd Annual WORLDSymposium.

Read more →
ZVRA
Feb 3, 2026
ZVRAConferences/Events

Multi-year subgroup analyses of Niemann-Pick disease type C participantstreated with arimoclomol in the US early access program (EAP)

The article discusses multi-year subgroup analyses of participants with Niemann-Pick disease type C who were treated with arimoclomol as part of the US early access program. These findings were presented at the 22nd Annual WORLD Symposium. The ongoing research reflects a commitment to exploring treatment options for this rare disease.

Read more →
ZVRA
Dec 2, 2025
ZVRAGeneral

Zevra Therapeutics, Inc. Appoints Alicia Secor to Board of Directors Announces Retirement of Wendy Dixon, PhD Celebration, FL

Zevra Therapeutics, Inc. announced the appointment of Alicia Secor to its Board of Directors and the retirement of Wendy Dixon, PhD. Ms. Secor brings over thirty years of experience in life sciences, most recently as CEO of Atalanta Therapeutics. The company emphasized the importance of her expertise in enhancing its strategies within the rare disease sector. The transition occurs amid Zevra's ongoing efforts to address unmet needs in rare disease treatments and to deliver value to its shareholders.

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ZVRA
Nov 20, 2025
ZVRAGeneral
▼ -6.5%on this news

Zevra Therapeutics, Inc. Announces CFO Transition Celebration, FL

Zevra Therapeutics, Inc. announced the transition of its Chief Financial Officer, R. LaDuane Clifton, who will step down effective December 31, 2025, to pursue other opportunities. Clifton, who has been with the company since 2015, has been credited for his leadership and pivotal role in the company's transition to a commercial-stage entity focusing on rare diseases. The company will begin searching for his successor as it looks to maintain its momentum and support its growth objectives going forward.

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ZVRA
Nov 5, 2025
ZVRAGeneral

Zevra Reports Third Quarter 2025 Financial Results and Corporate Update 2025 EPS of $(0.01) Q3 2025 net revenue of $26.1 million, driven by MIPLYFFA net revenue of $22.4 million Company to host conference call and webcas

Zevra Therapeutics reported its third-quarter financial results for 2025, showcasing a net revenue of $26.1 million, largely driven by MIPLYFFA, which generated $22.4 million. Notably, the company is maintaining strong market access for MIPLYFFA and has successfully enrolled patients in clinical trials for other products, including Arimoclomol. However, the company recorded a net loss of $(0.5) million, a positive shift from the previous year, and is reassessing the sales strategy for OLPRUVA. Zevra plans to host a conference call today to discuss these results further.

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ZVRA
Sep 23, 2025
ZVRAConferences/Events

Changing The Course of NPC: Long-term Evidence for Disease Modification in a Heterogenous Population

The article discusses long-term evidence for disease modification in Niemann-Pick disease (NPC), presented at the International Niemann-Pick Disease Alliance Meeting. The research highlights findings from a heterogeneous population, suggesting promising implications for treatment strategies. This presentation marks a significant step in understanding NPC and its management.

Read more →
ZVRA
Sep 9, 2025
ZVRAPhases

Safety and efficacy of arimoclomol in a pediatric substudy of Niemann-Pick disease type C patients aged 6 to <24 months at study enrollment

The article discusses a pediatric substudy evaluating the safety and efficacy of arimoclomol in patients with Niemann-Pick disease type C, specifically those aged 6 to under 24 months at enrollment. This research will be presented at the International Congress of Inborn Errors of Metabolism in 2025. The focus on young patients highlights the importance of developing treatments for rare diseases.

Read more →
ZVRA
Sep 9, 2025
ZVRAConferences/Events

Arimoclomol upregulates expression of genes belonging to the coordinated lysosomal expression and regulation (CLEAR) network

Arimoclomol has been shown to upregulate genes associated with the coordinated lysosomal expression and regulation (CLEAR) network. This finding was presented at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025, highlighting its potential implications for metabolic disorders. The research emphasizes the importance of lysosomal function in cellular health.

Read more →
ZVRA
Sep 9, 2025
ZVRAGeneral

Arimoclomol for the treatment of Niemann-Pick disease type C in a real-world setting: long-term outcomes from an expanded access program in the United States

The article discusses the long-term outcomes of Arimoclomol for treating Niemann-Pick disease type C, based on data from an expanded access program in the United States. The findings were presented at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. The results indicate a positive impact of the treatment in a real-world setting.

Read more →
ZVRA
Sep 9, 2025
ZVRAPhases

Efficacy results across a 12-month double-blind randomized trial and an open-label extension phase of arimoclomol for treatment of Niemann-Pick disease type C in patients treated with miglustat

The article discusses the efficacy results from a 12-month double-blind randomized trial and an open-label extension phase of arimoclomol for treating Niemann-Pick disease type C in patients already on miglustat. The findings were presented at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. The study aims to provide insights into the treatment's effectiveness over an extended period.

Read more →
ZVRA
Aug 12, 2025
ZVRAGeneral

Zevra Reports Second Quarter 2025 Financial Results and Corporate Update Q2 2025 net revenue of $25.9 million, driven by product net revenue of $21.8 million Completed sale of PRV for $150.0 million, bolstering the balan

Zevra Therapeutics reported strong financial results for Q2 2025, with net revenues of $25.9 million, driven largely by the launch of MIPLYFFA. The company has successfully sold its Pediatric Rare Disease Priority Review Voucher for $150 million, bolstering its balance sheet. Additionally, Zevra submitted a Marketing Authorisation Application for arimoclomol to the EMA for Niemann-Pick Disease Type C, indicating potential growth opportunities. Despite this progress, the company also faced challenges with a significant impairment charge and inventory obsolescence.

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ZVRA
Jul 20, 2025
ZVRAGeneral

ADMINISTRATION OF A DUAL-COATED SODIUM PHENYLBUTYRATE (OLPRUVA) SUSPENSION VIA GASTROSTOMY TUBE

The article discusses the administration of a dual-coated sodium phenylbutyrate suspension, known as Olpruva, via a gastrostomy tube. It provides an overview of the product and its application but lacks detailed information on clinical outcomes or specific events related to its use. The content appears to be more informational than newsworthy.

Read more →
ZVRA
Jul 20, 2025
ZVRAGeneral

Arimoclomol for the Treatment of Niemann-Pick Disease Type C in a Real-World Setting: Long-Term Outcomes From an Expanded Access Program in the United States

The article discusses the long-term outcomes of Arimoclomol in treating Niemann-Pick Disease Type C through an expanded access program in the U.S. The findings indicate positive results, showcasing the treatment's effectiveness in a real-world setting. This research contributes valuable insights into the management of this rare disease.

Read more →
ZVRA
Jul 20, 2025
ZVRAPhases

Long-Term Efficacy and Safety Evaluation of Arimoclomol Treatment in Patients With Niemann-Pick Disease Type C – Data From a 48-Month Open-Label Trial

The article discusses a 48-month open-label trial evaluating the long-term efficacy and safety of Arimoclomol in patients with Niemann-Pick Disease Type C. The findings suggest positive outcomes regarding the treatment's effectiveness and safety profile. This research could significantly impact treatment strategies for this rare disease.

Read more →
ZVRA
Jul 20, 2025
ZVRAGeneral

Arimoclomol Upregulates Expression of Genes Belonging to the Coordinated Lysosomal Expression and Regulation (CLEAR) Network

The article discusses the upregulation of gene expression by Arimoclomol within the CLEAR network. This finding highlights the drug's potential in influencing key biological processes. The implications of this research could pave the way for new therapeutic strategies in related conditions.

Read more →
ZVRA
Jul 16, 2025
ZVRAPhases

Long-term efficacy and safety of arimoclomol in Niemann-Pick disease type C: Final results of the phase 2/3 NPC-002 48-month open-label extension trial

The article discusses the final results of the phase 2/3 NPC-002 trial, focusing on the long-term efficacy and safety of arimoclomol in treating Niemann-Pick disease type C. Conducted over a 48-month open-label extension, the study shows promising outcomes, highlighting the drug's potential benefits for patients. The findings contribute significantly to the understanding of this rare genetic disorder.

Read more →
ZVRA
Jul 11, 2025
ZVRAConferences/Events

Long-Term Effectiveness and Safety Evaluation of Arimoclomol Treatment in Patients With Niemann-Pick Disease Type C – Data From the Pivotal Study and Open-Label Extension

The article discusses the long-term effectiveness and safety of Arimoclomol in patients with Niemann-Pick Disease Type C. Data from both the pivotal study and the open-label extension are highlighted, showcasing the treatment's positive outcomes. The findings were presented at the National Niemann Pick Disease Foundation Conference.

Read more →
ZVRA
Jul 11, 2025
ZVRAConferences/Events

Advances in Niemann-Pick Disease Type C Treatment: The Role of Arimoclomol

The article discusses advancements in the treatment of Niemann-Pick Disease Type C, focusing on the role of Arimoclomol. This treatment was a key topic at the National Niemann Pick Disease Foundation Conference held on July 11, 2025. The ongoing research and discussions aim to improve patient outcomes and raise awareness about the disease.

Read more →
ZVRA
Jun 17, 2025
ZVRAPhases

Efficacy results from a 12-month double-blind randomized trial of arimoclomol for treatment of Niemann-Pick disease type C (NPC): Presenting a rescored 4-domain NPC Clinical Severity Scale

A recent 12-month double-blind randomized trial evaluated the efficacy of arimoclomol for Niemann-Pick disease type C (NPC). The study presented a rescored 4-domain NPC Clinical Severity Scale, indicating potential benefits of the treatment. Results suggest that arimoclomol may improve clinical outcomes for patients with NPC.

Read more →
ZVRA
Apr 17, 2025
ZVRAGeneral

Mechanistic insights into arimoclomol mediated effects on lysosomal function in Niemann-pick type C disease

The article discusses a study published in 'Molecular Genetics and Metabolism' that explores the mechanistic effects of arimoclomol on lysosomal function in Niemann-pick type C disease. This research aims to enhance understanding of the drug's potential therapeutic benefits in this condition. The findings could provide valuable insights for future treatments.

Read more →
ZVRA
Apr 7, 2025
ZVRAGeneral

Zevra Announces Closing of Sale of Rare Pediatric Disease Priority Review Voucher for $150 Million Celebration, FL

Zevra Therapeutics has successfully closed the sale of its Rare Pediatric Disease Priority Review Voucher for $150 million. This milestone follows the FDA's approval of MIPLYFFA, which is the first treatment for Niemann-Pick type C, a rare neurodegenerative disease. The proceeds will provide non-dilutive capital to support Zevra's strategic priorities, including commercial launches and ongoing clinical trials. As of March 31, 2025, Zevra reported available cash and investments totaling approximately $68.7 million, which, combined with the proceeds from the PRV sale, bolsters its financial standing.

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ZVRA
Feb 27, 2025
ZVRAGeneral
▲ +5.4%on this news

Zevra Therapeutics Enters Agreement to Sell its Rare Pediatric Disease Priority Review Voucher for $150 Million Celebration, FL

Zevra Therapeutics has entered into a $150 million agreement to sell its Rare Pediatric Disease Priority Review Voucher. This transaction is expected to close within 30 to 45 days, strengthening the company's balance sheet. The funds will aid in the commercial launch of their products and advance their pipeline for rare diseases. The PRV was granted following FDA approval for MIPLYFFA, which treats Niemann-Pick disease type C.

Read more →
ZVRA
Feb 6, 2025
ZVRAPhases

Efficacy Results from a 12-month Double-blind Randomized Trial of Arimoclomol for the Treatment of Niemann-Pick Disease Type C — Presenting a Rescored 4-domain NPC Clinical Severity Scale

The article discusses the efficacy results from a 12-month double-blind randomized trial of Arimoclomol for treating Niemann-Pick Disease Type C. It highlights the use of a rescored 4-domain NPC Clinical Severity Scale to assess outcomes. The findings are set to be presented at the 21st Annual WORLDSymposium on February 7, 2025.

Read more →
ZVRA
Feb 3, 2025
ZVRAPhases

Qualitative Assessment of the Validity and Standardization of the Swallow Domain in the 5-domain Niemann-Pick Disease Type C (NPC) Clinical Severity Scale (5DNPCCSS) And Analysis in an NPC Clinical Trial Data Set

The article discusses a qualitative assessment of the swallow domain in the 5-domain Niemann-Pick Disease Type C Clinical Severity Scale. It emphasizes the importance of validity and standardization in clinical assessments. Additionally, the study analyzes data from an NPC clinical trial to enhance the understanding of the disease's severity.

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ZVRA
Feb 3, 2025
ZVRAConferences/Events

Arimoclomol Safety Profile in the Treatment of Niemann-pick Disease Type C In a Real-world Setting: Long-term Safety Data from an Expanded Access Program in the United States

The article discusses the long-term safety profile of Arimoclomol in treating Niemann-pick Disease Type C based on data from an expanded access program in the United States. The findings were presented at the 21st Annual WORLDSymposium. This real-world data may provide valuable insights into the drug's effectiveness and safety.

Read more →
ZVRA
Feb 3, 2025
ZVRAPhases

Long-term Efficacy and Safety Evaluation of Arimoclomol Treatment in Patients with Niemann-Pick Type C – Data From 48 Months Open Label Trial

The article discusses a 48-month open-label trial evaluating the long-term efficacy and safety of Arimoclomol in patients with Niemann-Pick Type C. The findings presented at the 21st Annual WORLDSymposium highlight the potential benefits of this treatment. The data suggests a positive outlook for patients receiving Arimoclomol.

Read more →
ZVRA
Feb 3, 2025
ZVRAConferences/Events

Safety of Arimoclomol in a Pediatric Sub-Study of Niemann-pick Disease Type C Patients Aged 6 To <24 Months at Study Enrollment

The article discusses a pediatric sub-study focusing on the safety of Arimoclomol for Niemann-pick Disease Type C patients aged 6 to less than 24 months. This study is set to be presented at the 21st Annual WORLDSymposium on February 5, 2025. The research aims to provide insights into the treatment's safety profile in a vulnerable population.

Read more →
ZVRA
Feb 3, 2025
ZVRAConferences/Events

Perseverance Is Key for Regulatory Success in Ultra-Rare Diseases – Key Learnings from Arimoclomol’s Regulatory Journey

The article discusses the regulatory journey of Arimoclomol, emphasizing the significance of perseverance in achieving success for treatments targeting ultra-rare diseases. It outlines key learnings that can aid in navigating complex regulatory landscapes, particularly for drugs aimed at rare conditions. This insight is shared in the context of the 21st Annual WORLDSymposium.

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ZVRA
Feb 3, 2025
ZVRAConferences/Events

Arimoclomol for the Treatment of Niemann-pick Disease Type C In a Real-world Setting: Long-term Data from an Expanded Access Program in the United States

The article discusses long-term data from an expanded access program for Arimoclomol, a treatment for Niemann-pick Disease Type C. Presented at the 21st Annual WORLDSymposium, the findings indicate positive outcomes in real-world settings. This data may enhance understanding of Arimoclomol's efficacy over time.

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ZVRA
Feb 3, 2025
ZVRAPhases

Efficacy Results from A 12-month Double-blind Randomised Trial of Arimoclomol for Treatment of Niemann-Pick Disease Type C – Presenting A Rescored 4-domain NPC Clinical Severity Scale

The article discusses the efficacy results from a 12-month double-blind randomized trial of Arimoclomol for treating Niemann-Pick Disease Type C. The trial introduces a rescored 4-domain NPC Clinical Severity Scale, which aims to improve the evaluation of treatment outcomes. These findings were presented at the 21st Annual WORLDSymposium.

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ZVRA
Nov 11, 2024
ZVRAConferences/Events

Qualitative Assessment of the Validity and Standardization of the Swallow Domain in the 5-Domain Niemann-Pick disease type C (NPC) Clinical Severity Scale (5DNPCCSS)

The article discusses a qualitative assessment regarding the validity and standardization of the swallow domain in the 5-Domain Niemann-Pick disease type C Clinical Severity Scale. This assessment is set to be presented at the Child Neurology Society Annual Meeting in November 2024. The focus is on improving clinical evaluations for patients with Niemann-Pick disease type C.

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ZVRA
Sep 5, 2024
ZVRAConferences/Events

Modeling the pharmacokinetics of phenylbutyrate in fed and fasted states

The article discusses a presentation on the pharmacokinetics of phenylbutyrate, which will be featured at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium. The study examines the drug's behavior in both fed and fasted states, contributing valuable insights to metabolic research. This research is expected to enhance understanding of phenylbutyrate's effectiveness.

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ZVRA
Sep 5, 2024
ZVRAGeneral

Arimoclomol for the Treatment of NPC in a Real-World Setting: Long-Term Outcomes from an Expanded Access Program in the USA

The article discusses the long-term outcomes of Arimoclomol for treating Niemann-Pick disease type C (NPC) in a real-world setting, based on data from an expanded access program in the USA. The findings will be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium. The results suggest that Arimoclomol may provide significant benefits for NPC patients.

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ZVRA
Sep 5, 2024
ZVRAGeneral

Arimoclomol Safety Profile in the Treatment of NPC in a Real-World Setting: Long-Term Data From an Expanded Access Program in the USA

The article discusses the safety profile of Arimoclomol in treating Niemann-Pick disease type C (NPC) based on long-term data from an expanded access program in the USA. This data was presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium. The findings suggest a favorable safety profile for the drug in a real-world setting.

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ZVRA
Sep 5, 2024
ZVRAPhases

Long-term Efficacy and Safety Evaluation of Arimoclomol Treatment in Patients with Niemann Pick Type C – Data from 48 Months Open Label Trial

The article discusses the long-term efficacy and safety of Arimoclomol in treating Niemann Pick Type C, based on data from a 48-month open-label trial. The findings will be presented at the SSIEM 2024 Annual Symposium. The trial results are anticipated to contribute valuable insights into the treatment's effectiveness and safety profile.

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ZVRA
Sep 5, 2024
ZVRAPhases

Efficacy Results from a 12-month Double-blind Randomized Trial of Arimoclomol for Treatment of Niemann Pick Disease Type C – Presenting an Improved 4-Domain NPC Clinical Severity Scale

The article discusses the efficacy results from a 12-month double-blind randomized trial of Arimoclomol for treating Niemann Pick Disease Type C. The study introduces an improved 4-domain NPC clinical severity scale, highlighting the treatment's potential benefits. The results will be presented at the Society for the Study of Inborn Errors of Metabolism's 2024 Annual Symposium.

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ZVRA
Apr 15, 2024
ZVRAGeneral

Arimoclomol in adults with NPC in a real-world setting: Long-term data from an expanded access program in the USA

The article discusses long-term data from an expanded access program for Arimoclomol in adults with Niemann-Pick disease type C (NPC) in the USA. Presented at the Society for Inherited Metabolic Disorders (SIMD), the findings highlight the drug's potential benefits in a real-world context. This data contributes to understanding Arimoclomol's effectiveness and safety.

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ZVRA
Nov 20, 2023
ZVRAGeneral

Zevra Therapeutics Completes Acquisition of Acer Therapeutics in its Journey to Become a Leading Rare Disease Company Acquisition includes OLPRUVA , an FDA-approved treatment for urea cycle disorders (UCDs), which propel

Zevra Therapeutics has finalized its acquisition of Acer Therapeutics, a significant move aimed at establishing Zevra as a key player in the rare disease sector. The acquisition includes OLPRUVA, an FDA-approved therapy for urea cycle disorders, broadening Zevra's clinical portfolio and enhancing its revenue opportunities. This strategic transaction also brings in additional assets and personnel to bolster Zevra's capabilities in drug development and commercialization. The completion of this merger is expected to facilitate the delivery of innovative therapies for patients with limited treatment options.

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ZVRA
Oct 4, 2023
ZVRAGeneral

Evaluation of the Long-Term Effect of Arimoclomol in NPC – 48 Months Data from CT-ORZY-NPC-002

The article discusses the long-term effects of Arimoclomol in treating Niemann-Pick disease type C (NPC), presenting data from a 48-month study (CT-ORZY-NPC-002). This evaluation was showcased at the 52nd Child Neurology Society Annual Meeting, indicating the ongoing research and interest in NPC therapies.

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ZVRA
Oct 4, 2023
ZVRAConferences/Events

Real World Data Collection in Niemann-Pick Disease Type C – Data from Expanded Access Program with Arimoclomol

The article discusses the presentation of real-world data collected from an expanded access program for Arimoclomol in Niemann-Pick Disease Type C. This presentation took place at the 52nd Child Neurology Society Annual Meeting on October 5, 2023. The focus on real-world data highlights the importance of practical insights in understanding treatment efficacy.

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ZVRA
Aug 31, 2023
ZVRAGeneral

Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio and Adding Commercial Product Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra s pur

Zevra Therapeutics has announced its intention to acquire Acer Therapeutics in a deal valued at up to $91 million, which includes stock and contingent value rights. This acquisition aims to bolster Zevra's rare disease portfolio with the inclusion of OLPRUVA, an FDA-approved treatment for urea cycle disorders, expected to enhance and diversify revenue streams. The transaction, anticipated to close in Q4 2023, has been approved by both companies' boards, but remains subject to shareholder approval and other customary conditions.

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ZVRA
May 16, 2022
ZVRAFDA Updates

KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Pipeline Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the trea

KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the treatment of Niemann-Pick disease type C (NPC), a rare progressive neur

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ZVRA
Jan 8, 2021
ZVRAGeneral

KemPharm Announces Pricing of $50 Million Public Offering of Common Stock and Warrants and Uplisting to The Nasdaq Capital Market Common stock will begin trading on The Nasdaq Capital Market under the ticker symbol KMPH

KemPharm Announces Pricing of $50 Million Public Offering of Common Stock and Warrants and Uplisting to The Nasdaq Capital Market Common stock will begin trading on The Nasdaq Capital Market under the ticker symbol KMPH today, January 8, 2021 Celebration, FL January 8, 2021 Ke

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ZVRA
Dec 31, 2020
ZVRAGeneral

EXECUTIVE COMPENSATION Our chief executive officer and two of our other most highly compensated executive officers for the year ended

EXECUTIVE COMPENSATION Our chief executive officer and two of our other most highly compensated executive officers for the year ended December 31, 2020 are listed below: We refer to these executive officers as our named executive officers. Summary Compensation Table table pre

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ZVRA
Dec 18, 2019
ZVRAGeneral

KemPharm Announces Debt Restructuring with Deerfield and Delaware Street Capital Principal and Interest Payments on Outstanding Debt in Principal Amount of $77.7M Pushed to

KemPharm Announces Debt Restructuring with Deerfield and Delaware Street Capital Principal and Interest Payments on Outstanding Debt in Principal Amount of $77.7M Pushed to March 31, 2021; Expected to Extend Cash Runway to New Maturity Date KemPharm Will Host a Conference Call

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ZVRA
Sep 20, 2019
ZVRAGeneral

KemPharm Provides Updates Regarding its Board of Directors

KemPharm Provides Updates Regarding its Board of Directors Celebration, FL - September 20, 2019 - KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that, on September 18, 2019, Dann

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ZVRA
Sep 4, 2019
ZVRAGeneral

KemPharm Announces Entry into Definitive Collaboration and License Agreement for its ADHD Candidates, KP415 and KP484, with an Affiliate of Gurnet Point Capital Up to a Total of $493 Million in Upfront, Sales and Develop

KemPharm Announces Entry into Definitive Collaboration and License Agreement for its ADHD Candidates, KP415 and KP484, with an Affiliate of Gurnet Point Capital Up to a Total of $493 Million in Upfront, Sales and Development Milestone Payments, as well as Royalties on Net Sale

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ZVRA
Aug 13, 2019
ZVRAGeneral

KemPharm Reports Second Quarter 2019 Results

KemPharm Reports Second Quarter 2019 Results Celebration, FL - August 13, 2019 - KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today reported its corporate and financial results for the quarter

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ZVRA
May 14, 2019
ZVRAGeneral

KemPharm Reports First Quarter 2019 Results

KemPharm Reports First Quarter 2019 Results Development & Regulatory Highlights: Completed KP415 Pre-NDA Meeting with FDA Provided Update on APADAZ Formulary Adoption Announced FDA Approval of sNDA for Two Additional Strengths of APADAZ Corporate & Financial Highlights:

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ZVRA
Feb 28, 2019
ZVRAGeneral

KemPharm Reports Q4 and FY 2018 Results

KemPharm Reports Q4 and FY 2018 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Development & Regulatory Highlights: Completed KP415 clinical and human abuse potential programs Received approval of APADAZ Enhance

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ZVRA
Nov 8, 2018
ZVRAGeneral

KemPharm, Inc.

KemPharm, Inc. Reports Third Quarter 2018 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Development Highlights: Announced positive topline results from KP415.E01 efficacy and safety trial in children with attention

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ZVRA
Oct 5, 2018
ZVRAGeneral

KemPharm Announces Pricing of Public Offering of Common Stock Coralville, IA

KemPharm Announces Pricing of Public Offering of Common Stock Coralville, IA October 5, 2018 KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced the pricing of its underwritten public

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ZVRA
Oct 4, 2018
ZVRAGeneral

KemPharm Announces Proposed Public Offering of Common Stock Coralville, IA

KemPharm Announces Proposed Public Offering of Common Stock Coralville, IA October 4, 2018 KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that it intends to offer and sell shares

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ZVRA
Mar 29, 2018
ZVRAGeneral

KemPharm Reports Fourth Quarter and Year End 2017 Results

KemPharm Reports Fourth Quarter and Year End 2017 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Development & Regulatory Highlights: FDA Approval Announced of APADAZ (benzhydrocodone and acetaminophen) for the Shor

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ZVRA
Feb 23, 2018
ZVRAFDA Updates

KemPharm Announces FDA Approval of Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain

KemPharm Announces FDA Approval of Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain Apadaz is the First Prodrug of Hydrocodone/Acetaminophen to be Approved by FDA Conference Call and Live Audio Webcast with Slide Presentation Scheduled for

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ZVRA
Nov 9, 2017
ZVRAGeneral

KemPharm Reports Third Quarter 2017 Results and Provides Corporate Update

KemPharm Reports Third Quarter 2017 Results and Provides Corporate Update Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Development & Regulatory Highlights: Entered into Licensing and Assignment Agreement with Genco Scienc

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ZVRA
Sep 12, 2017
ZVRAFDA Updates

KemPharm Announces FDRR Process Completion and Resubmission of the Apadaz NDA FDA Has Assigned a PDUFA Action Date of

KemPharm Announces FDRR Process Completion and Resubmission of the Apadaz NDA FDA Has Assigned a PDUFA Action Date of February 23, 2018 Conference Call and Live Audio Webcast Today at 8:30 a.m. ET Coralville, IA - September 12, 2017 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-

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ZVRA
Aug 10, 2017
ZVRAConferences/Events

KemPharm, Inc. Reports Second Quarter 2017 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Clinical Development & Regulatory Highlights: PK415.109 Pharmacokineti

KemPharm, Inc. Reports Second Quarter 2017 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Clinical Development & Regulatory Highlights: Held KP415 End-of-Phase 1 Meeting with U.S. Food and Drug Administration (FDA)

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ZVRA
Aug 10, 2017
ZVRAPhases

KemPharm Announces Preliminary Results from KP415 Pharmacokinetic Single and Multiple Dose Trial Phase I Study Results Demonstrated Early Peak Exposure to d-Methylphenidate followed by Sustained Duration in both Single a

KemPharm Announces Preliminary Results from KP415 Pharmacokinetic Single and Multiple Dose Trial Phase I Study Results Demonstrated Early Peak Exposure to d-Methylphenidate followed by Sustained Duration in both Single and Multiple Dose Settings Coralville, IA - August 10, 2017

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ZVRA
Jun 28, 2017
ZVRAFDA Updates

KemPharm Strengthens ADHD Prodrug Pipeline with Development of KP484, A New, Super-Extended Release ADHD Methylphenidate Product Candidate KP415 End-of-Phase 1 Meeting with FDA Affirms KemPharm s Development Plan and Pot

KemPharm Strengthens ADHD Prodrug Pipeline with Development of KP484, A New, Super-Extended Release ADHD Methylphenidate Product Candidate KP415 End-of-Phase 1 Meeting with FDA Affirms KemPharm's Development Plan and Potential NDA Submission as early as late 2018 Conference Cal

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ZVRA
May 23, 2017
ZVRAConferences/Events

KemPharm, Inc. Reports First Quarter 2017 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Clinical Development & Regulatory Highlights: Reported Positive Data fr

KemPharm, Inc. Reports First Quarter 2017 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Clinical Development & Regulatory Highlights: Financial Highlights: Coralville, IA - May 10, 2017 (Updated May 23, 2017) - KemP

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ZVRA
Mar 9, 2017
ZVRAConferences/Events

KemPharm, Inc. Reports Fourth Quarter and Year End 2016 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Repo

KemPharm, Inc. Reports Fourth Quarter and Year End 2016 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Received Clearance from FDA to Initiate Clinical Program fo

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ZVRA
Jan 9, 2017
ZVRAPhases

KemPharm Reports Positive Data from Phase 1 Intranasal Pharmacokinetic Study of KP511, An Investigational Prodrug of Hydromorphone for the Treatment of Pain Statistically significant pharmacokinetic and pharmacodynamic d

KemPharm Reports Positive Data from Phase 1 Intranasal Pharmacokinetic Study of KP511, An Investigational Prodrug of Hydromorphone for the Treatment of Pain Statistically significant pharmacokinetic and pharmacodynamic differences of abuse potential were observed in the KP511.A0

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ZVRA
Dec 14, 2016
ZVRAPhases

KemPharm 's KP415, An Investigational Prodrug of D-Methylphenidate, Completes Phase 1 Proof-of-Concept Trial for the Treatment of ADHD Both Early and Extended Release of the Methylphenidate Prodrug was observed in the KP

KemPharm's KP415, An Investigational Prodrug of D-Methylphenidate, Completes Phase 1 Proof-of-Concept Trial for the Treatment of ADHD Both Early and Extended Release of the Methylphenidate Prodrug was observed in the KP415.101 Study Conference Call and Live Audio Webcast with D

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ZVRA
Nov 9, 2016
ZVRAConferences/Events

KemPharm, Inc. Reports Third Quarter 2016 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 5:00 p.m., ET Recent Clinical Development & Regulatory Highlights: Prioritized KP415

KemPharm, Inc. Reports Third Quarter 2016 Results Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 5:00 p.m., ET Recent Clinical Development & Regulatory Highlights: Recent Corporate and Financial Highlights: Coralville, IA - November 9, 2

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ZVRA
Oct 18, 2016
ZVRAGeneral

KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion Abuse-Deterrent Technology Agreement focused on KemPharm's current and in-development IR Opioid Pipeline Coralville, IA and Palatine, IL

KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion Abuse-Deterrent Technology Agreement focused on KemPharm's current and in-development IR Opioid Pipeline Coralville, IA and Palatine, IL - Oct. 18, 2016 - KemPharm, Inc. (NASDAQ:KMPH), a clinical-sta

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ZVRA
Sep 21, 2016
ZVRAConferences/Events

KEMPHARM NDRS PRESENTATION 09-21-16

KEMPHARM NDRS PRESENTATION 09-21-16

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ZVRA
Sep 15, 2016
ZVRAConferences/Events

KemPharm, Inc. Provides Corporate and Clinical Updat e Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. E T KemPharm adjusts product development timelines following full pipeline analysis and posit

KemPharm, Inc. Provides Corporate and Clinical Update Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. ET KemPharm adjusts product development timelines following full pipeline analysis and positions KP415 and KP201/IR as lead product candidates to capi

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ZVRA
Aug 10, 2016
ZVRAFDA Updates

KemPharm , Inc. Reports Second Quarter 2016 Results Conference Call and Live Audio Webcast Scheduled for Today at 8 :30 a.m. , ET Recent Clinical Development & Regulatory Highlights: Completed FDA End of Review meeting f

KemPharm, Inc. Reports Second Quarter 2016 Results Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m., ET Recent Clinical Development & Regulatory Highlights: Recent Corporate and Financial Highlights: Net income of $9.8 million, or $0.59 per basic shar

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ZVRA
Jun 28, 2016
ZVRAPhases

KemPharm 's Prodrug of Hydromorphone, KP511 , Demonstrates Comparable Oral Pharmacokinetics to Hydromorphone in Phase 1 Trial KP511 clinical data consistent with preclinical animal data Coralville, IA

KemPharm's Prodrug of Hydromorphone, KP511, Demonstrates Comparable Oral Pharmacokinetics to Hydromorphone in Phase 1 Trial KP511 clinical data consistent with preclinical animal data Coralville, IA - June 28, 2016 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty ph

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ZVRA
Jun 13, 2016
ZVRAFDA Updates

FDA Issues Complete Response Letter for Apadaz TM New Drug Application Coralville, IA

FDA Issues Complete Response Letter for ApadazTM New Drug Application Coralville, IA - June 13, 2016 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S.

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ZVRA
Jun 9, 2016
ZVRAFDA Updates

KemPharm Files NDA Amendment Request with FDA for Apadaz TM Discussions On-going with FDA on Potential Apadaz Product Label ing Coralville, IA

KemPharm Files NDA Amendment Request with FDA for ApadazTM Discussions On-going with FDA on Potential Apadaz Product Labeling Coralville, IA - June 9, 2016 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and developmen

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ZVRA
May 12, 2016
ZVRAConferences/Events

KemPharm, Inc. Reports First Quarter 2016 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Introduced Apadaz as the proprietary name

KemPharm, Inc. Reports First Quarter 2016 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Recent Corporate and Financial Highlights: Coralville, IA - May 12, 2016 - KemPharm, Inc. (NASDAQ:

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ZVRA
May 5, 2016
ZVRAFDA Updates

Statement Regarding FDA Advisory Committee Meeting on KemPharm's Abuse-Deterrent Product Candidate Apadaz TM Coralville, IA

Statement Regarding FDA Advisory Committee Meeting on KemPharm's Abuse-Deterrent Product Candidate ApadazTM Coralville, IA - May 5, 2016 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary pro

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ZVRA
Mar 10, 2016
ZVRAFDA Updates

KemPharm, Inc. Reports Q4 and Year End 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Submitted New Drug Application (NDA) und

KemPharm, Inc. Reports Q4 and Year End 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights: Recent Corporate and Financial Highlights: Coralville, IA - March 10, 2016 - KemPharm, Inc. (NAS

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ZVRA
Feb 10, 2016
ZVRAFDA Updates

FDA Grants Priority Review to KemPharm for KP201/APAP NDA If approved, KP201/APAP could become the first immediate-release hydrocodone combination product with abuse-deterrent properties Coralville, IA

FDA Grants Priority Review to KemPharm for KP201/APAP NDA If approved, KP201/APAP could become the first immediate-release hydrocodone combination product with abuse-deterrent properties Coralville, IA - February 10, 2016 - KemPharm, Inc. (NASDAQ: KMPH) today announced that the

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ZVRA
Feb 9, 2016
ZVRAGeneral

to KemPharm's Current Report on Form 8-K, filed with the Securities and Exchange Commission on

KemPharm Announces Pricing of $75.0 Million 5.50% Senior Convertible Notes Due 2021 Coralville, IA - February 4, 2016 - KemPharm, Inc. (NASDAQ: KMPH) announced today the pricing of $75.0 million aggregate principal amount of 5.50% senior convertible notes due 2021 (the "notes")

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ZVRA
Dec 30, 2015
ZVRAGeneral

KemPharm, Inc. Expands Pain Therapy Pipeline with Discovery of KP746 Novel Prodrug of Oxymorphone Adds New Asset to KemPharm's Advancing Abuse-Deterrent Product Portfolio Coralville, IA

KemPharm, Inc. Expands Pain Therapy Pipeline with Discovery of KP746 Novel Prodrug of Oxymorphone Adds New Asset to KemPharm's Advancing Abuse-Deterrent Product Portfolio Coralville, IA - December 30, 2015 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutic

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ZVRA
Dec 18, 2015
ZVRAGeneral

Unless the context otherwise requires, we use the terms KemPharm, the Company, we, us and our in this Current Report on Form 8-K, or this Report, to refer to KemPharm, Inc. We have proprietary rights to a number of trade

Unless the context otherwise requires, we use the terms KemPharm, the Company, we, us and our in this Current Report on Form 8-K, or this Report, to refer to KemPharm, Inc. We have proprietary rights to a number of trademarks used in this Report that are important to our busines

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ZVRA
Dec 15, 2015
ZVRAFDA Updates

KemPharm Submits NDA for KP201/APAP and Requests Priority Review from the FDA If approved, KP201/APAP may be the first immediate release hydrocodone combination product candidate for the treatment of acute pain designed

KemPharm Submits NDA for KP201/APAP and Requests Priority Review from the FDA If approved, KP201/APAP may be the first immediate release hydrocodone combination product candidate for the treatment of acute pain designed to address opioid abuse and misuse Coralville, IA - Decemb

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ZVRA
Dec 8, 2015
ZVRAConferences/Events

Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical tri

December 8, 2015 26th Annual Oppenheimer Healthcare Conference Exhibit 99.1 Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our pla

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ZVRA
Nov 12, 2015
ZVRAConferences/Events

KemPharm, Inc. Reports Q3 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development Highlights: Completed Human Abuse Liability Program for KP201/APAP, KemPharm's

KemPharm, Inc. Reports Q3 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development Highlights: Recent Product and Financial Highlights: Coralville, IA - November 12, 2015 - KemPharm, Inc. (NASDAQ: KMPH), a clinical-st

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ZVRA
Oct 21, 2015
ZVRAPhases

KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP Results from Second Intranasal Human Abuse Liability Clinical Trial Reaffirm Properties of KP201/APAP Conference Call and Live Audio Webcast Scheduled

KemPharm, Inc. Completes Human Abuse Liability Program for KP201/APAP Results from Second Intranasal Human Abuse Liability Clinical Trial Reaffirm Properties of KP201/APAP Conference Call and Live Audio Webcast Scheduled for Today at 5:00 p.m. ET Coralville, IA - October 21, 2

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ZVRA
Sep 30, 2015
ZVRAGeneral

KemPharm Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP Results Indicate that Prodrug Design of KP201/APAP Significantly Hinders Traditional Means of Abuse, Including Extraction, Injection

KemPharm Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP Results Indicate that Prodrug Design of KP201/APAP Significantly Hinders Traditional Means of Abuse, Including Extraction, Injection and Smoking Coralville, IA - September 30, 2015 - KemPharm

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ZVRA
Sep 24, 2015
ZVRAGeneral

KemPharm Expands its Abuse-Deterrent Opioid Pipeline with New Acetaminophen-Free, Immediate Release Hydrocodone and Immediate Release Oxycodone Prodrug Product Candidates Provides Updates on Clinical Development Pipeline

KemPharm Expands its Abuse-Deterrent Opioid Pipeline with New Acetaminophen-Free, Immediate Release Hydrocodone and Immediate Release Oxycodone Prodrug Product Candidates Provides Updates on Clinical Development Pipeline and Anticipated NDA Filings Coralville, IA - September 24

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ZVRA
Sep 18, 2015
ZVRAConferences/Events

Cautionary Note Regarding Presentation Information This presentation has been prepared by KemPharm, Inc. (the "Company") for informational purposes only and for only the actual attendees of this presentation. Nothing con

September 23, 2015 The 9th Pain & Migraine Therapeutics Summit The Search for New Pain Therapeutics with Low Inherent Abuse Potential - A Case for Prodrugs Sven Guenther, Ph.D. Exhibit 99.1 Cautionary Note Regarding Presentation Information This presentation has been prepared by

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ZVRA
Aug 13, 2015
ZVRAPhases

KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results Results from First of Two Intranasal Human Abuse Liability Clinical Studies Indicate KP201 Exhibit

KemPharm, Inc. Announces Positive Data from Intranasal Human Abuse Liability Study of KP201/APAP; Reports Q2 2015 Results Results from First of Two Intranasal Human Abuse Liability Clinical Studies Indicate KP201 Exhibits Significantly Lower Exposure to Hydrocodone When Administ

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ZVRA
Aug 12, 2015
ZVRAConferences/Events

Cautionary Note Regarding Presentation Information This presentation contains forward looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical tri

Studies conducted in rats. 0 500 1,000 1,500 2,000 2,500 3,000 3,500 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 Dose [mg/kg HM] HM HCl extrapolated HM HCl (HM) KP511 (HM) 0 5 10 15 20 25 30 35 0 1 2 3 4 Time [h] 26 Treatment for ADHD KP415 Overview 27 KP415 Overview Prodrug

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ZVRA
Jun 25, 2015
ZVRAGeneral

KemPharm, Inc. Announces Changes to Senior Leadership to Target Strategic Opportunities Rusty Johnson Named as Newly Created Chief Business Officer; LaDuane Clifton Appointed as Chief Financial Officer Coralville, IA

KemPharm, Inc. Announces Changes to Senior Leadership to Target Strategic Opportunities Rusty Johnson Named as Newly Created Chief Business Officer; LaDuane Clifton Appointed as Chief Financial Officer Coralville, IA June 25, 2015 KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage

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ZVRA
Jun 16, 2015
ZVRAConferences/Events

Kempharm Management Presentation

Kempharm Management Presentation June 16, 2015 Cautionary Note Regarding Presentation Information This presentation contains forward-looking statements, including statements about our plans to develop and commercialize our product candidates, our planned clinical trials for KP2

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ZVRA
Jun 11, 2015
ZVRAPhases

KemPharm, Inc. Reports Positive Data from Oral Human Abuse Liability Clinical Trial of KP201/APAP Company to Host Conference Call and Live Audio Webcast Today at 8:30 a.m. ET Coralville, IA

KemPharm, Inc. Reports Positive Data from Oral Human Abuse Liability Clinical Trial of KP201/APAP Company to Host Conference Call and Live Audio Webcast Today at 8:30 a.m. ET Coralville, IA June 11, 2015 KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical

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ZVRA
May 20, 2015
ZVRAFDA Updates

KemPharm, Inc. Reports Q1 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Highlights: Completed pre-NDA meeting for KP201/APAP with FDA on

KemPharm, Inc. Reports Q1 2015 Results Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET May 27, 2015 KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, toda

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