ZGNX Zogenix Inc.

18.87
+1.34  (+8%)
Previous Close 17.53
Open 18.06
52 Week Low 16.73
52 Week High 32.42
Market Cap $1,053,183,573
Shares 55,812,590
Float 55,568,803
Enterprise Value $631,850,073
Volume 1,117,981
Av. Daily Volume 652,177
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Upcoming Catalysts

Drug Stage Catalyst Date
FINTEPLA
Lennox-Gastaut syndrome
sNDA Filing
sNDA Filing
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MT1621
Thymidine kinase 2 deficiency
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
FINTEPLA
CDKL5 Deficiency Disorder
Phase 3
Phase 3
Phase 3 trial to be initiated in 2021.
FINTEPLA (ZX008)
Dravet syndrom
Approved
Approved
FDA approval announced June 25, 2020.
Abuse deterrent formulations of Zohydro ER
Moderate to severe pain
Approved
Approved
Approved January 30, 2015.
Zohydro ER
Moderate to severe pain
Approved
Approved
Approved October 25, 2013.
Sumavel
Migraine
Approved
Approved
Approved July 16, 2009.

Latest News

    • Continued positive momentum for U.S. launch of FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, with total net product sales of $12.3 million and total revenue of $13.7 million in the first quarter, representing quarter-over-quarter increases of 53% and 61%, respectively
    • As of March 31, 2021, in the U.S., over 700 patients referred to the FINTEPLA REMS program, with over 560 patients receiving reimbursed therapy
    • Successfully launched FINTEPLA in Germany in February and commenced the Zogenix Access Program to expand global access to FINTEPLA, including in European countries where reimbursement has not yet been established
    • On track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021 and in Europe in Q4
    • Continued positive momentum for U.S. launch of FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, with total net product sales of $12.3 million and total revenue of $13.7 million in the first quarter, representing quarter-over-quarter increases of 53% and 61%, respectively
    • As of March 31, 2021, in the U.S., over 700 patients referred to the FINTEPLA REMS program, with over 560 patients receiving reimbursed therapy
    • Successfully launched FINTEPLA in Germany in February and commenced the Zogenix Access Program to expand global access to FINTEPLA, including in European countries where reimbursement has not yet been established
    • On track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021 and in Europe in Q4 2021
    • Planned New Drug Application (NDA) submission in first half of 2022 for MT1621 in TK2 deficiency
    • Intend to meet with FDA in current quarter to discuss Phase 3 study of FINTEPLA for the treatment of seizures associated with CDKL5 Deficiency Disorder (CDD)

    EMERYVILLE, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three months ended March 31, 2021, and provided a corporate update. The Company will host a conference call today, Thursday, May 6, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "We are pleased with the continued positive momentum in our U.S. launch of FINTEPLA® in Dravet Syndrome, where we see increased adoption by existing and new prescribers and patients," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "Our dialogue with U.S. payors is progressing very well, as we work to expand access for patients who could benefit from FINTEPLA treatment. In Europe, our initial launch in Germany has begun in an encouragingly strong manner and our recently established Zogenix Access Program will expand access to FINTEPLA for physicians globally, including in European countries where reimbursement has not yet been established. Additionally, we are working to submit an NDA in Japan for FINTEPLA in the second half of this year."

    "We have the opportunity to potentially make FINTEPLA available to additional patients in need in multiple additional indications, and remain on track to submit global regulatory filings in Lennox-Gastaut syndrome (LGS) later this year and anticipate meeting with the FDA this quarter to discuss the planned Phase 3 trial for CDKL5 deficiency disorder," continued Dr. Farr. "Lastly, in our MT1621 program for TK2 deficiency, we continue to prepare for an NDA filing in the first half of 2022."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:
      • As of March 31, 2021, approximately 570 prescribers in the U.S. had successfully completed the Risk Evaluation and Mitigation Strategy (REMS) certification process
      • As of March 31, 2021, over 700 patients in the U.S. had been referred to the FINTEPLA REMS program to become eligible to receive therapy, and over 560 patients were receiving reimbursed therapy.
      • Received European Commission approval in December 2020; FINTEPLA commercially available in Germany as of February 1, 2021
      • Received temporary authorization to use FINTEPLA in France from the French National Agency for Medicines and Health Products Safety in January 2021; currently onboarding patients
      • Continued to advance reimbursement and pricing discussions with other major European countries, including the UK, Italy and France
      • Launched Zogenix Access Program to expand access to FINTEPLA for physicians in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established
      • Anticipate submission of an NDA in Japan (J-NDA) to Japan's Pharmaceutical and Medical Devices Agency in the second half of 2021
      • Presented new data from an investigator-initiated study of FINTEPLA in Dravet syndrome at American Academy of Neurology (AAN) Annual Meeting in April 2021, which highlighted certain quality-of-life benefits for patients and caregivers after patients received treatment with FINTEPLA
      • In March, two additional issued patents were listed in the Orange Book, bringing the total number of Orange Book listed patents for FINTEPLA to 10.
    • FINTEPLA for the treatment of seizures associated with LGS:
      • Compilation of data package is ongoing with anticipated submission of supplemental NDA in the third quarter of 2021
      • Anticipate submitting Marketing Authorization Application with European Medicines Agency in fourth quarter of 2021
      • Presented new data for FINTEPLA in LGS at AAN Annual Meeting, demonstrating that patients treated with FINTEPLA showed improvements in everyday executive function
    • FINTEPLA for the treatment of seizures associated with CDKL5 Deficiency Disorder:
      • Anticipate meeting with U.S. Food and Drug Administration (FDA) in the second quarter of 2021 to discuss plans for upcoming Phase 3 safety and efficacy study
      • Expect to initiate a Phase 3 study of FINTEPLA for the treatment of CDKL5 Deficiency Disorder during the second half of 2021
    • MT1621 for the treatment of TK2 deficiency:
      • Studies continue to proceed as planned and Company anticipates the submission of an NDA in the first half of 2022

    First Quarter 2021 Financial Results

    • The Company recorded $13.7 million in revenue for the first quarter ended March 31, 2021, which was an increase of 61% as compared to the $8.5 million recorded in the fourth quarter of 2020. This included total net product sales of FINTEPLA of $12.3 million, which were an increase of 53% as compared to the $8.1 million reported in the fourth quarter of 2020, in addition to $1.3 million in collaboration revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded total revenue of $1.2 million for the three months ended March 31, 2020, which consisted solely of collaboration revenue.

    • Research and development expenses for the first quarter ended March 31, 2021, totaled $31.0 million, compared to $33.2 million in the first quarter ended March 31, 2020.

    • Selling, general and administrative expenses for the first quarter ended March 31, 2021, totaled $ 31.3 million, up from $21.3 million in the first quarter ended March 31, 2020. The increase was driven by the commercial launch of FINTEPLA in the U.S. and launch preparations in Europe.

    • Net loss for the first quarter ended March 31, 2021, was $55.6 million, or a net loss of $1.00 per share, compared with a net loss of $25.8 million, or a net loss of $0.54 per share, in the first quarter ended March 31, 2020.

    • As of March 31, 2021, the Company had $435.2 million in cash, cash equivalents, and marketable securities, compared to $505.1 million at December 31, 2020.



    Conference Call Details

    Thursday, May 6, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free: 877-846-2690
    International: 416-981-9029
    Conference ID: 21993693
    Webcast:http://public.viavid.com/index.php?id=144590



    About Zogenix


    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs, one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: the timing of commercial launch of FINTEPLA for the treatment of Dravet syndrome in additional countries in Europe; Zogenix's expectations on the submission of a J-NDA by Nippon Shinyaku in Japan; the timing and ability of Zogenix to complete regulatory submissions in the U.S. and the European for FINTEPLA in LGS; Zogenix's plans to expand FINTEPLA in other indications including the timing or success of a Phase 3 clinical trial in CDD and investigator-initiated clinical trials in other indications; and Zogenix's expectations regarding meeting with the FDA to discuss FINTEPLA in CDD. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA and may delay Zogenix's development plans for FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix's ongoing studies may contradict or undermine the data previously reported; patient outcomes may differ from the data previously reported and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



    ZOGENIX, INC.


    CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

    (In thousands)

     March 31, 2021 December 31, 2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$86,317   $166,916  
    Marketable securities348,905   338,193  
    Accounts receivable, net6,119   3,824  
    Inventory2,324   1,026  
    Prepaid expenses and other current assets11,065   12,215  
    Total current assets454,730   522,174  
    Property and equipment, net8,377   8,724  
    Operating lease right-of-use assets7,452   7,748  
    Intangible asset, net96,587   98,558  
    Goodwill6,234   6,234  
    Other non-current assets7,584   7,692  
    Total assets$580,964   $651,130  
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$11,964   $11,945  
    Accrued and other current liabilities30,749   54,964  
    Deferred revenue, current5,297   5,318  
    Current portion of operating lease liabilities1,621   1,688  
    Current portion of contingent consideration8,900   8,800  
    Total current liabilities58,531   82,715  
    Deferred revenue, noncurrent5,664   5,479  
    Operating lease liabilities, net of current portion9,937   10,314  
    Contingent consideration, net of current portion34,100   33,600  
    Convertible senior notes151,451   149,353  
    Total liabilities259,683   281,461  
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock and additional paid-in capital1,701,788   1,694,580  
    Accumulated deficit(1,380,470)  (1,324,840) 
    Accumulated other comprehensive loss(37)  (71) 
    Total stockholders' equity321,281   369,669  
    Total liabilities and stockholders' equity$580,964   $651,130  



    ZOGENIX, INC.


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

    (In thousands, except per share amounts)

     Three Months Ended March 31,
     2021 2020
    Revenues:   
    Net product sales$12,349   $  
    Collaboration revenue1,335   1,249  
    Total revenues13,684   1,249  
    Costs and expenses:   
    Cost of product sales (excluding amortization of intangible asset)676     
    Research and development30,969   33,240  
    Selling, general and administrative31,272   21,318  
    Intangible asset amortization1,971     
    Acquired in-process research and development costs   1,500  
    Change in fair value of contingent consideration600   (7,900) 
    Total costs and expenses65,488   48,158  
    Loss from operations(51,804)  (46,909) 
    Interest income308   1,088  
    Interest expense(3,737)    
    Other (expense) income, net(397)  20,021  
    Net loss$(55,630)  $(25,800) 
        
    Net loss per share, basic and diluted$(1.00)  $(0.54) 
        
    Weighted average number of shares used in the calculation of basic and diluted net loss per common share55,750   48,185  

     



    Primary Logo

    View Full Article Hide Full Article
    • FINTEPLA is approved in the U.S. and European Union as an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.
    • The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.

    EMERYVILLE, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced the launch of its new global access program for FINTEPLA (fenfluramine) oral solution. FINTEPLA was approved in the U.S. and European Union in 2020 as an add-on therapy for the treatment of seizures associated with a debilitating…

    • FINTEPLA is approved in the U.S. and European Union as an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.

    • The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.

    EMERYVILLE, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced the launch of its new global access program for FINTEPLA (fenfluramine) oral solution. FINTEPLA was approved in the U.S. and European Union in 2020 as an add-on therapy for the treatment of seizures associated with a debilitating rare epilepsy called Dravet syndrome in patients aged two years and older. The Zogenix Access Program expands access for physicians in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.

    "Three randomized clinical studies have demonstrated FINTEPLA's ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled despite treatment with one or more other anti-epileptic medicines," said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. "With these results and more than one thousand treated Dravet syndrome patients, physicians in many countries have expressed interest in FINTEPLA for their patients. We are pleased to be able to take this step to support their requests and help more patients in need."

    Zogenix has partnered with Durbin, a part of Uniphar Group's Product Access Division and a leading specialist in the international distribution of specialized pharmaceuticals, to manage the Zogenix Access Program for FINTEPLA. Durbin has extensive global experience providing, high-quality support while adhering to complex local requirements.

    "We are delighted to be working in partnership with Zogenix on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division. "We look forward to helping facilitate broader access to FINTEPLA for patients with critical unmet medical needs."

    About the Zogenix Access Program

    The Zogenix Access Program is for physicians who are interested in treating their patients with FINTEPLA in countries where it is not yet available commercially or through local access schemes. The program does not provide free-of-charge access to FINTEPLA and does not affect patients already taking FINTEPLA as part of a clinical study. Specifics of the program may vary by country based on local regulations.

    In the U.S. and Europe, treatment with FINTEPLA is initiated and supervised by physicians with experience in the treatment of epilepsy under a Risk Evaluation Mitigation Strategy (REMS) program (U.S.) or Controlled Access Program (EU). Similarly, access through this program must be requested by the patient's treating physician. Where local regulations allow, an initial registration process enables the program team to begin working with physicians on treatment and important safeguard planning.

    Physicians can learn more about the Zogenix Access Program for FINTEPLA by sending an email inquiry to .

    About FINTEPLA®

    Fintepla is a new treatment option that in clinical studies provided significant, well-tolerated, and lasting seizure reduction to many Dravet syndrome study patients. In 2020, FINTEPLA (fenfluramine) oral solution was approved by the U.S. Food & Drug Administration (FDA) and by the European Commission as an add on therapy to other anti-epileptic medicines for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix recently reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, a study that corroborated the statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multi-national Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.

    In the United States, please see important prescribing and safety information at www.Fintepla.com. In Europe, please see important prescribing and safety information at www.Fintepla.eu.

    About Dravet Syndrome

    Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor, and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families, and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.

    About Durbin

    Durbin is a specialist pharmaceutical services provider, distributing critical medications to over 160 different countries. A part of Uniphar Group's Product Access Division, Durbin works in partnership with global pharmaceutical and biotech companies to provide Early Access Programs (EAPs), including Named Patient Supply and Cohort Programs. The company has over 25 years' experience designing and implementing EAPs from concept and specializes in developing robust and compliant voluntary data collection initiatives that run seamlessly alongside the programs they manage.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs, one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the timing of the availability of FINTEPLA through the Zogenix Access Program; and Zogenix's expectations on the submission of a J-NDA by Nippon Shinyaku in Japan. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch the Zogenix Access Program for FINTEPLA globally; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process, the controlled access program or the Zogenix Access Program; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA, including through the Zogenix Access Program; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



    Primary Logo

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    • LGS is one of the most challenging developmental and epileptic encephalopathies to manage because of high seizure frequency and significant neurodevelopmental impairment.
    • More LGS study patients treated with FINTEPLA (fenfluramine) showed improvement in each of the BRIEF 2 indexes that have been used to assess behavior, emotion, and cognitive function in intractable epilepsy and other developmental conditions.
    • Improvement was statistically significant for Cognition (27% vs 13% placebo, p=0.046) and the Global Executive Composite score (25% vs 11% placebo, p=0.034), where approximately twice as many patients achieved clinically meaningful improvement.

    EMERYVILLE, Calif., April 22, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical…

    • LGS is one of the most challenging developmental and epileptic encephalopathies to manage because of high seizure frequency and significant neurodevelopmental impairment.
    • More LGS study patients treated with FINTEPLA (fenfluramine) showed improvement in each of the BRIEF 2 indexes that have been used to assess behavior, emotion, and cognitive function in intractable epilepsy and other developmental conditions.
    • Improvement was statistically significant for Cognition (27% vs 13% placebo, p=0.046) and the Global Executive Composite score (25% vs 11% placebo, p=0.034), where approximately twice as many patients achieved clinically meaningful improvement.

    EMERYVILLE, Calif., April 22, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced new data showing the positive impact of treatment with FINTEPLA® (fenfluramine) oral solution on everyday executive function for children and young adults with Lennox-Gastaut syndrome (LGS). FINTEPLA is being investigated for the treatment of seizures associated with LGS, a rare, severe epilepsy that is one of the most challenging developmental and epileptic encephalopathies to manage due to the high seizure frequency and significant neurodevelopmental impairment patients experience.

    The data, presented in an oral presentation and fireside chat at the virtual American Academy of Neurology (AAN) Annual Meeting this week, was the first presentation of FINTEPLA's impact on LGS patients' abilities to self-regulate behavior, emotions, and cognition. These new data complement earlier Phase 3 trial data demonstrating FINTEPLA's ability to significantly reduce drop seizure frequency and, especially, generalized tonic-clonic seizure frequency (a primary risk factor for sudden unexpected death in epilepsy, or SUDEP) for many LGS patients.

    "FINTEPLA-treated children and young adults with LGS showed improved overall self-regulation, with specific improvements in regulation of attention and cognition after 14 weeks in a Phase 3 double-blind randomized controlled trial," said Kim Bishop, Ph.D. of Global Pharma Consultancy and lead author for the study. "Better self-regulation can have a positive impact on children's everyday functioning and reduce caregiver burden."

    Analysis

    The objective of this post-hoc analysis was to assess the impact of FINTEPLA (fenfluramine) on everyday executive function as captured using the Behavior Rating Inventory of Executive Function (BRIEF®) as part of the Zogenix 14-week randomized Phase 3 clinical trial of children and young adults with LGS. The BRIEF assessments were completed by caregivers or parents as part of the trial, which included a total of 263 LGS patients aged 2-35 years. After a 4-week baseline, patients were randomized to placebo or one of two fenfluramine doses. Treatment continued for a combined 14-week titration and maintenance period. Age-appropriate versions of the BRIEF were administered at baseline and end of study.

    This analysis included 137 patients (age 6-18) that had both baseline and end of-study BRIEF assessments (median age of 12 years), mapping the BRIEF ratings to the current BRIEF® 2 parent form, a shorter, 63-item version, which incorporates a large, 1,400-sample size normative population and statistics to support interpretation. This analysis did not include patients over 18 years of age because normative population data in adults is not yet available. The BRIEF 2 analysis utilizes the Reliable Change Index (RCI) for Behavior, Emotion, Cognition, and Global scores that represent a degree of confidence that the change represents a real effect (versus test-related errors and practice effects), and therefore is clinically meaningful. Associations between change in BRIEF 2 scores and combined active (0.2 and 0.7 mg/kg/day fenfluramine) versus placebo treatment groups were evaluated in cross tabulations using Somers' D statistic.

    Results

    Mean age of patients in the FINTEPLA (n=92) vs. placebo (n=45) groups was 12 ± 3.6, with 44% of the FINTEPLA patients being female vs. 53% in the placebo group. The frequency of clinically elevated T-scores at baseline, defined as a T-score ≥65, was substantial, suggesting frequent impairment in executive function, as would be expected for children with LGS. Subjects with greater improvement in seizure control were more likely to show clinically meaningful improvements in executive functioning after the 14-week study duration.

    More patients on FINTEPLA (fenfluramine) than placebo showed improvement in each of the four BRIEF 2 indexes (Behavior, Emotions, Cognition, and Global Executive Composite). Improvement was significantly greater for the CRI (Cognition) and GEC (Global Executive Composite) scores, indicating clinically meaningful improvement in the FINTEPLA (fenfluramine)-treated patients.

    Percentage of Patients Showing Clinically Meaningful Improvement

    (RCI ≥95% Certainty) in Active vs Placebo Treatment Groups
    BRIEF® 2 IndexFINTEPLA®

    Fenfluramine (%)

    (N=92)
    Placebo (%)

    (N=45)
    P-Value
    BRI (Behavior)24%13%0.118
    ERI (Emotions)19%16%0.665
    CRI (Cognition)27%13%0.046
    GEC (Global Executive Composite overarching summary score)25%11%0.034

    "Analyses from our separate Phase 3 trials and long-term open label studies in Dravet syndrome, another difficult to treat rare epilepsy, showed that FINTEPLA provided sustained, clinically meaningful improvements in seizure control and executive function," said Gail Farfel, Ph.D., Executive Vice President and Chief Development Officer at Zogenix and one of the study authors. "With a growing set of differentiating data in Lennox-Gastaut syndrome, we remain eager to continue advancing FINTEPLA as a potential new treatment option for patients living with this incredibly refractory disease."

    Presentation

    Dr. Kim Bishop presented and discussed the data during Virtual AAN 2021; the slides from her presentation are archived on the Zogenix Newsroom.

    About Lennox-Gastaut Syndrome

    Lennox-Gastaut Syndrome (LGS) is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes. LGS is characterized by many different seizure types, including many that result in frequent falls and injuries and that often don't respond to currently available seizure medications The intellectual and behavioral problems associated with LGS, as well as around-the-clock care requirements, add to the complexity of life with this disease.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs, one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in patient outcomes and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |  



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  1. EMERYVILLE, Calif., April 22, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the first quarter ended March 31, 2021 and host a corporate update conference call and webcast after the market close on Thursday, May 6, 2021, at 4:30 PM Eastern Time.

    Conference Call Details
    Thursday, May 6, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:                877-846-2690  
    International:                416-981-9029
    Conference ID:        21993693
    Webcast:                http://public.viavid.com/index.php?id=144590

    About Zogenix
    Zogenix is a global biopharmaceutical company committed to developing and commercializing…

    EMERYVILLE, Calif., April 22, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will report its financial results for the first quarter ended March 31, 2021 and host a corporate update conference call and webcast after the market close on Thursday, May 6, 2021, at 4:30 PM Eastern Time.

    Conference Call Details

    Thursday, May 6, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:                877-846-2690  
    International:                416-981-9029
    Conference ID:        21993693
    Webcast:                http://public.viavid.com/index.php?id=144590

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs, one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

     



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    • Seizure Related Benefits noted by caregivers included reduction in frequency, fewer triggers causing seizures, and shorter recovery time when seizure did occur.

    • Non-Seizure benefits most commonly noted include improvements in executive functions such as cognition, learning, and problem solving, as well as mood, sleep quality, and motor function.

    • The majority of caregivers reported feeling less stress, anxiety, and depression, with 62% of employed parents missing less work.

    EMERYVILLE, Calif., April 16, 2021 (GLOBE NEWSWIRE) --  Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced new findings from an investigator-initiated study designed to assess caregivers' perspectives on the long-term…

    • Seizure Related Benefits noted by caregivers included reduction in frequency, fewer triggers causing seizures, and shorter recovery time when seizure did occur.



    • Non-Seizure benefits most commonly noted include improvements in executive functions such as cognition, learning, and problem solving, as well as mood, sleep quality, and motor function.



    • The majority of caregivers reported feeling less stress, anxiety, and depression, with 62% of employed parents missing less work.

    EMERYVILLE, Calif., April 16, 2021 (GLOBE NEWSWIRE) --  Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced new findings from an investigator-initiated study designed to assess caregivers' perspectives on the long-term seizure- and non-seizure-related benefits of FINTEPLA® (fenfluramine) on patients with Dravet syndrome, a rare, severe epilepsy, and on their caregivers and families. Data from the study is being presented during the virtual American Academy of Neurology (AAN) Annual Meeting, April 17-22, 2021.

    "The impact of Dravet syndrome on the lives of the diagnosed child and the family members who care and worry about their loved one can be severe and unrelenting," said Mark Jensen, Ph.D., Vice Chair for Research in Rehabilitation Medicine at UW Medicine, Professor of Rehabilitation Medicine at the University of Washington, and lead author for the study. "Our study shows that treatment with FINTEPLA not only reduces seizure activity, but also results in substantial benefits for many other aspects of the lives of those impacted by Dravet syndrome. The majority of caregivers reported that after treatment began, they felt less overwhelmed, less anxiety, and less stress. They noted improvements in sleep in both the child and themselves, and even noticed improvements in the siblings of the child with Dravet syndrome. As they witnessed these improvements, they experienced, for the first time in many years, hope for the future of their child."

    Study Methodology

    Caregivers of patients who received FINTEPLA through either the Phase 3 clinical trial program or the U.S. early access program were recruited to participate in one-on-one semi-structured interviews to discuss the benefits of fenfluramine for the child with Dravet syndrome, as well as the parents and the family as a whole. A total of 59 caregivers with a mean age of 48, 85% female, and 88% living with their partner or spouse participated in the interviews. Discussions were audiotaped and used to generate summaries which were analyzed to identify themes for responses. The numbers and rates of responses in each category were then computed (for example, responses about topics such as shorter post-seizure recovery time). Caregivers also provided demographic and clinical information about their child with Dravet syndrome and completed a self-report survey about their own health and quality of life.

    Study Results

    Of the participants interviewed, 34% were caregivers of adult patients with Dravet syndrome. Mean age of patients with Dravet syndrome was 15 years (range, 2-33 years) and they had been on the FINTEPLA treatment regimen for an average of 21 months (range, 5-59 months).

    • The most commonly reported non-seizure-related improvements were in the areas of cognition (76%), alertness (68%), education (65%), problem solving (56%), speech (48%), sleep quality (47%), motor function (46%), and mood (41%).
    • Caregiver parents themselves reported feeling less overwhelmed (71%), less stress (66%), and less anxiety and depression (68%). More than two-thirds reported that the quality of their sleep improved (71%) and they had more time to do things they enjoy (56%). In addition, 44% of parents reported that the relationship with their spouse or partner improved and 62% of employed parents missed less work.
    • Reported family benefits included less family stress (76%), improved relationship between the Dravet syndrome child and their siblings (56%), improved behavior and/or mood of siblings (58%), and easier time for their family to do things with others (64%).

    "In three Phase 3 studies, FINTEPLA has demonstrated the ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled on their existing anti-epileptic medicines," said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix and one of the study authors. "This qualitative study provides insight directly from caregivers about the real world benefits they observe in their children and family as a result of their child being treated with FINTEPLA. These findings further support the data reported in our Phase 3 studies related to seizure and non-seizure outcomes."

    The poster, titled "Caregivers' Perspectives on the Long-Term Seizure- and Non-Seizure-Related Benefits of Fenfluramine on Patients with Dravet Syndrome and Their Families" (Amtmann, Salem, Gammaitoni et al), is also available on the Zogenix Newsroom.

    About Dravet Syndrome

    Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.

    About FINTEPLA® (fenfluramine) oral solution

    FINTEPLA (fenfluramine) oral solution is approved in the United States, has received a positive CHMP opinion in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, and is being investigated as a potential treatment for Lennox-Gastaut syndrome (LGS) and other rare and severe childhood-onset epilepsy disorders.

    United States

    IMPORTANT SAFETY INFORMATION

    Boxed WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

    • There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
    • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
    • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

    Contraindications

    FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use of, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

    WARNINGS AND PRECAUTIONS

    Valvular Heart Disease and Pulmonary Arterial Hypertension (see boxed Warning)

    Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of this condition. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed valvular heart disease or pulmonary arterial hypertension.

    Monitoring

    Prior to starting treatment, patients must undergo an echocardiogram to evaluate for valvular heart disease and pulmonary arterial hypertension. Echocardiograms should be repeated every 6 months, and once 3-6 months post-treatment with FINTEPLA.

    If valvular heart disease or pulmonary arterial hypertension is observed on an echocardiogram, the prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA.

    FINTEPLA REMS Program (see boxed Warning)

    In the United States, FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program. Prescribers must be certified by enrolling in the FINTEPLA REMS program. Prescribers must Counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the REMS program and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the REMS program and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

    Decreased Appetite and Decreased Weight

    FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Most patients resumed the expected measured increases in weight by the end of the open-label extension study. Weight should be monitored regularly during treatment with FINTEPLA and dose modifications should be considered if a decrease in weight is observed.

    Somnolence, Sedation, and Lethargy

    FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

    Suicidal Behavior and Ideation

    Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

    Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

    Withdrawal of Antiepileptic Drugs

    As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

    Serotonin Syndrome

    Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly with concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA, dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

    Increase in Blood Pressure

    FINTEPLA can cause an increase in blood pressure. Significant elevation in blood pressure, including hypertensive crisis, has been reported rarely in adult patients treated with fenfluramine, including patients without a history of hypertension. Monitor blood pressure in patients treated with FINTEPLA. In clinical trials of up to 3 years in duration, no patient receiving FINTEPLA developed hypertensive crisis.

    Glaucoma

    Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

    Adverse Reactions

    The most common adverse reactions (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

    Drug Interactions

    Strong CYP1A2 and CYP2B6 Inducers: Coadministration with rifampin or a strong CYP1A2 and CYP2B6 inducer will decrease fenfluramine plasma concentrations.

    Consider an increase in FINTEPLA dosage when coadministered with rifampin or a strong CYP1A2 and CYP2B6 inducer.

    Use in Specific Populations

    Administration to patients with moderate or severe renal impairment or to patients with hepatic impairment is not recommended.

    Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.

    About Zogenix

    Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.

    Forward-Looking Statement

    Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients and Zogenix's plans to commercialize fenfluramine in Europe. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to successfully launch FINTEPLA, including launching a controlled access program implemented due to risks related to valvular heart disease and pulmonary arterial hypertension; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

    CONTACTS:

    Zogenix

    Melinda Baker

    Senior Director, Corporate Communications

    +1 (510) 788-8732 | 

    Investors

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC

    +1 (212) 915-2578 | 

    Media

    Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |



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