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Zogenix, Inc. (ZGNX)

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Previous Close18.34
Open18.25
Bid19.28 x 800
Ask19.33 x 1800
Day's Range18.01 - 19.31
52 Week Range16.65 - 54.16
Volume1,276,485
Avg. Volume909,416
Market Cap1.074B
Beta (5Y Monthly)1.52
PE Ratio (TTM)N/A
EPS (TTM)-3.84
Earnings DateMar 02, 2021 - Mar 06, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est47.36
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  • Zogenix Announces Preliminary, Unaudited Fourth Quarter 2020 Net Product Sales
    GlobeNewswire

    Zogenix Announces Preliminary, Unaudited Fourth Quarter 2020 Net Product Sales

    * Total FINTEPLA® preliminary, unaudited net product sales of approximately $8.1 million for the fourth quarter * As of December 31, 2020, 492 healthcare prescribers had completed FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification process * As of December 31, 2020, more than 550 patients had been prescribed FINTEPLA and were enrolled in the REMS program, and 416 patients were receiving reimbursed therapy * Cash, cash equivalents and marketable securities at December 31, 2020, were approximately $505.8 millionEMERYVILLE, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today reported select preliminary, unaudited financial results for the fourth quarter and full-year 2020. In addition, the Company highlighted its key 2021 corporate objectives.“2020 marked a year of tremendous achievements for Zogenix, highlighted by the successful commercial launch of FINTEPLA® in Dravet syndrome in the U.S.,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We are extremely pleased with our launch progress and believe our strong results in the fourth quarter reinforce FINTEPLA’s potential to provide transformational and durable seizure reduction for many Dravet syndrome patients. We look forward to further increasing U.S. physician and patient adoption of FINTEPLA in the year ahead. Moreover, we are excited to launch FINTEPLA in the EU shortly, following recent receipt of marketing authorization.”Preliminary, Unaudited Fourth Quarter FINTEPLA Net Product Sales Based on preliminary, unaudited financial information, the Company expects total FINTEPLA net product sales to be approximately $8.1 million for the fourth quarter of 2020. Unaudited cash, cash equivalents and marketable securities at December 31, 2020, were approximately $505.8 million.The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the Company’s fourth quarter of 2020. Zogenix expects to report its complete financial results for the fourth quarter and full-year 2020 in February 2021.As of December 31, 2020, 492 healthcare providers had completed the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) certification process. In addition, as of December 31, 2020, more than 550 patients had been prescribed FINTEPLA and were enrolled in the REMS program, and a total of 416 patients were receiving reimbursed therapy, of which approximately 60% were new to FINTEPLA.Key 2021 Corporate Objectives FINTEPLA Commercialization: * Continue to drive adoption of FINTEPLA in the U.S. by building on the positive momentum with existing and new prescribing physicians * Continue to work in partnership with U.S. payors to provide optimal access to FINTEPLA for all appropriate patients * Launch FINTEPLA for the treatment of patients with Dravet syndrome in Europe, beginning with the planned launch in Germany in the first quarter of 2021 * Secure positive pricing and reimbursement decisions in major European countries * Submit J-NDA in Japan for FINTEPLA for the treatment of patients with Dravet syndrome in collaboration with Zogenix’s partner, Nippon Shinyaku * Significantly expand the eligible patient population for FINTEPLA by submitting an sNDA in the U.S. for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndromeAdditional FINTEPLA Pipeline Programs: * Initiate a Phase 3 study of FINTEPLA for the treatment of CDKL5 Deficiency Disorder, an infantile-onset genetic seizure disorder * Continue to explore FINTEPLA as a potential treatment for additional severe, treatment-resistant rare epilepsies through the initiation of other company-sponsored clinical studiesMT1621 * Complete all clinical, non-clinical and CMC studies and assessments required to support planned 2022 U.S. NDA and EMA MAA submissions for MT1621, the Company’s investigational treatment for patients with the mitochondrial disease, thymidine kinase 2 deficiency (TK2d) Early-Stage R&D Activities * Support research and drug discovery activities with Zogenix’s partner, Tevard Biosciences, to advance novel gene therapy candidates for the treatment of Dravet syndrome and other serious, treatment-resistant genetic epilepsies About ZogenixZogenix 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 the rare epilepsy, Lennox-Gastaut syndrome, 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. Further information on FINTEPLA is available at www.FINTEPLA.com.Forward-Looking StatementZogenix 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 Zogenix’s preliminary, unaudited financial results for the fourth quarter 2020, expectations regarding U.S. FINTEPLA adoption growth; Zogenix’s plans to commercialize FINTEPLA in Europe, including the timing of the launch; and Zogenix’s 2021 corporate objectives. 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: adjustments to the preliminary, unaudited financial results in connection with completion of financial closing procedures and an audit for the 2020 fiscal year; the timing of enrollment or results of Zogenix’s clinical trials; the timing of planned regulatory submissions and Zogenix’s dependence on its partner Nippon Shinyaku with respect to the J-NDA for FINTEPLA for the treatment of patients with Dravet syndrome; the COVID-19 pandemic may disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA in the U.S. and Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could delay submission of new drug applications, 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 | corpcomms@zogenix.comInvestors Brian Ritchie  Managing Director, LifeSci Advisors LLC +1 (212) 915-2578 | britchie@lifesciadvisors.comMedia Stefanie Tuck, Vice President, Porter Novelli +1 (978) 390-1394 | stefanie.tuck@porternovelli.com

  • Is ZGNX A Good Stock To Buy According To Hedge Funds?
    Insider Monkey

    Is ZGNX A Good Stock To Buy According To Hedge Funds?

    The 800+ hedge funds and famous money managers tracked by Insider Monkey have already compiled and submitted their 13F filings for the third quarter, which unveil their equity positions as of September 30. We went through these filings, fixed typos and other more significant errors and identified the changes in hedge fund portfolios. Our extensive […]

  • The European Commission Approves Zogenix’s FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Dravet Syndrome
    GlobeNewswire

    The European Commission Approves Zogenix’s FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Dravet Syndrome

    * Dravet syndrome is a rare, debilitating and difficult-to-treat lifelong epilepsy that begins in infancy * EC approval is based on Phase 3 study data demonstrating that FINTEPLA safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on existing medications, including stiripentol * First EU market launch planned for Germany in Q1 2021 EMERYVILLE, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that the European Commission (EC) has granted marketing authorization for FINTEPLA® (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioral impairments, and an increased risk of sudden premature death (SUDEP).“We deeply appreciate the physicians and Dravet community whose support led to this important milestone,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “With the EC approval in place, we can now begin making FINTEPLA more widely available for the treatment of Dravet syndrome patients in Europe who seek new safe and effective treatment options.”The EC’s approval of FINTEPLA was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years.“After a healthy start in life, children with Dravet syndrome suffer from frequent and prolonged epileptic seizures, which determine the future of the child and mean that parents are on constant alert. Current treatments for Dravet syndrome are unsatisfactory, resulting in the disease affecting motor and mental development,” said Dr. Tilman Polster, a pediatric epilepsy specialist at the Mara Hospital of the Bethel Epilepsy Centre in Bielefeld, Germany, and primary investigator for fenfluramine oral solution in Dravet syndrome in Germany. “Experience from clinical studies has shown that FINTEPLA offers an impressive reduction in seizures, plus an improvement in quality of life. In conjunction with the ongoing data being collected on the safety profile of the therapy, FINTEPLA represents an effective new treatment option and an important hope for the families concerned.”When added to other antiepileptic therapies, including stiripentol, FINTEPLA provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients treated with this included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.With this approval, and subject to price and reimbursement being implemented according to national regulations, Zogenix will be able to market FINTEPLA in all European Union member countries, and in the United Kingdom, Norway, Iceland, and Liechtenstein.Controlled Access Program FINTEPLA will be available in Europe under a controlled access program requested by the European Medicines Agency to prevent off-label use for weight management and to confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking FINTEPLA.Zogenix will also conduct the FINTEPLA Registry, an observational registry to provide data on long-term safety of FINTEPLA and frequency of echocardiographic monitoring in routine practice.Earlier this year, FINTEPLA was approved by the U.S. Food & Drug Administration (FDA) 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, which corroborated the highly statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multinational Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.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 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 StatementZogenix 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; Zogenix’s plans to commercialize fenfluramine in Europe, including the timing of the launch. 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, and the conduct of the FINTEPLA Registry, and the timing thereof; 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 | corpcomms@zogenix.comInvestors Brian Ritchie  Managing Director, LifeSci Advisors LLC +1 (212) 915-2578 | britchie@lifesciadvisors.comMedia In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli +44 (0) 7949 794 290 | kerry.lloyd-jones@porternovelli.co.uk In the US: Stefanie Tuck, Vice President, Porter Novelli +1 (978) 390-1394 | stefanie.tuck@porternovelli.com