ZGNX Zogenix Inc.

22.08
+0.59  (+3%)
Previous Close 21.49
Open 21.63
52 Week Low 16.65
52 Week High 57.22
Market Cap $1,229,262,732
Shares 55,673,131
Float 55,386,789
Enterprise Value $811,522,585
Volume 841,598
Av. Daily Volume 1,387,076
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Drug Stage Catalyst Date
MT1621
Thymidine kinase 2 deficiency
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Drug Pipeline

Drug Stage Notes
FINTEPLA (ZX008)
Dravet syndrom
Approved
Approved
FDA approval announced June 25, 2020.
ZX008 - (Study 1601)
Lennox-Gastaut syndrome
Phase 3
Phase 3
Phase 3 data met primary endpoint with high dose, low dose secondary endpoint not met - February 6, 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

  1. CAMBRIDGE, Mass. and EMERYVILLE, Calif., Dec. 3, 2020 /PRNewswire/ -- Tevard Biosciences, a privately-held biotechnology company pioneering tRNA-based gene therapies, and Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that the companies have entered into a collaboration to identify and develop novel tRNA-based gene therapies for Dravet syndrome and other genetic epilepsies.

    Under the collaboration, Tevard will utilize its two unique tRNA-based discovery platforms focused on mRNA Stabilization and Nonsense Codon Suppression to discover and advance novel drug candidates for the treatment of Dravet syndrome and other genetic epilepsies. Zogenix will further develop the candidates through advanced preclinical studies and clinical development, and be responsible for worldwide commercialization.

    Zogenix is responsible for funding the collaboration and, under the terms of the agreement, Tevard will receive an initial collaboration payment of $10 million, of which approximately $5 million has previously been paid by Zogenix. Tevard will also receive $5 million in the form of a convertible note. Tevard is also eligible to receive additional development, regulatory and commercial-related milestone payments ranging from $70 million to $100 million for each program, as well as tiered royalties on future net global sales on any commercial products that result from the collaboration.

    Tevard's unique tRNA technology platforms are designed to address underlying genetic mutations in a precise and regulated manner through the correction of nonsense mutations and the enhanced production of functional proteins. Together, these approaches hold promise to treat genetic disorders that are not well-suited to conventional gene replacement approaches.

    "We are pleased to announce our collaboration with Zogenix, whose commitment to developing new treatments for Dravet syndrome and other genetic epilepsies is unparalleled," said Daniel E. Fischer, Co-founder, President, and Chief Executive Officer at Tevard Biosciences. "Tevard has assembled a team of leading experts focused on developing our breakthrough tRNA-based gene therapy platforms. Our collaboration with Zogenix will advance our mission to bring transformative gene therapy products to those living with Dravet and other rare and severe genetic disorders.

    "We are thrilled to be working with an innovative company like Tevard to develop promising next-generation therapies," said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. "Through this important new collaboration, we have reinforced our long-term commitment to transforming the lives of rare epilepsy patients and their families, and look forward to sharing updates as our work together progresses."

    About Dravet Syndrome

    Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of death (SUDEP). In addition to the catastrophic impact on the patient, the severity and unpredictability of the seizures, coupled with around-the-clock concern for the diagnosed child's safety and well-being, can present significant emotional and logistical challenges for parents and all members of the family.

    About Tevard Biosciences

    Tevard Biosciences is a privately held biotechnology company pioneering tRNA-based gene therapies to cure rare and severe genetic diseases with limited or no approved treatment options. Tevard was founded by MIT Professor and Whitehead Institute Founding Member Harvey Lodish, Ph.D., with life science entrepreneurs and executives Daniel Fischer and Warren Lammert, fathers of children with Dravet syndrome. The company is developing and applying two novel tRNA-based gene therapy platforms, co-invented by Professor Lodish with Johns Hopkins School of Medicine Professor Jeff Coller, Ph.D. and University of Iowa Professor Chris Ahern, Ph.D., for Dravet syndrome and other rare diseases caused by haploinsufficiency and/or nonsense mutations that are not amenable to traditional approaches to gene therapy. For more information, please visit www.tevard.com.

    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 received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    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 potential that the use tRNA-based discovery platforms will result in the discovery and advancement novel drug candidates for the treatment of genetic epilepsies; and Zogenix's intention to develop any drug candidates discovered through tRNA-based discovery platforms. 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, uncertainties related to pharmaceutical product development, including whether any drug candidate will be discovered; results from preclinical or clinical studies may not support the continued development or commercialization of any discovered drug candidate; delays or disruptions in Zogenix's or Tevard's business operations due to the COVID-19 pandemic 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:

    Tevard Biosciences 

    Investors and Media 

    Karen L. Bergman for Tevard

    +1 (650) 575-1509

    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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/tevard-biosciences-and-zogenix-announce-collaboration-to-advance-novel-gene-therapies-for-dravet-syndrome-and-other-genetic-epilepsies-301186221.html

    SOURCE Tevard Biosciences

    View Full Article Hide Full Article
    • New long-term safety, efficacy, and durability data for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome

    • Full results from Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome

    • New data from investigator-initiated study in CDKL5 Deficiency Disorder

    EMERYVILLE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that data from eleven poster presentations related to FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies will be presented at the American Epilepsy Society (AES) Annual Meeting, being held virtually from December 4-8, 2020. Zogenix will also host a virtual scientific…

    • New long-term safety, efficacy, and durability data for FINTEPLA® (fenfluramine) oral solution in Dravet syndrome



    • Full results from Phase 3 study of FINTEPLA in Lennox-Gastaut syndrome



    • New data from investigator-initiated study in CDKL5 Deficiency Disorder

    EMERYVILLE, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that data from eleven poster presentations related to FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies will be presented at the American Epilepsy Society (AES) Annual Meeting, being held virtually from December 4-8, 2020. Zogenix will also host a virtual scientific exhibition room and sponsor a continuing medical education (CME) symposium during AES 2020.

    "We are honored to collaborate with leading international epilepsy experts to broaden our understanding of how FINTEPLA, a drug recently approved by the FDA to treat seizures associated with Dravet syndrome, may improve the lives of epilepsy patients and their families," said Zogenix's Chief Medical Officer Bradley S. Galer, M.D. "With new long-term data in Dravet syndrome, full results from our Lennox-Gastaut syndrome Phase 3 trial, and data from investigator-initiated studies, we are eager to continue advancing FINTEPLA as a potential new treatment option for additional rare epilepsies."

    Main Conference

    Full data for the FINTEPLA posters presented in the main conference will be available on the AES 2020 conference site starting this Friday, December 4, at 9:00 a.m. Eastern Time and will be available after AES on the Zogenix Newsroom site. Authors will be available to discuss their data with attendees during the following times:

    • Efficacy and Tolerability of Adjunctive FINTEPLA (Fenfluramine Hydrochloride) in an Open-Label Extension Study of Dravet Syndrome Patients Treated for Up to 3 Years

      Scheffer, Devinsky, Perry et al

      Poster #978

      Authors available: Monday, December 7, 1:303:00 PM ET
    • Treatment with FINTEPLA (Fenfluramine) in Patients with Dravet Syndrome has no Long-Term Effect on Weight and Growth

      Gil-Nagel, Ceulemans, Wirrell et al

      Poster #977

      Authors available: Monday, December 7, 1:303:00 PM ET
    • Fenfluramine (FINTEPLA) Provides Comparable Clinical Benefit in Adults and Children with Dravet Syndrome: Real-World Experience from the US Early Access Program

      Perry, Knupp, Wirrell, et al

      Poster #1057

      Authors available: Monday, December 7, 1:303:00 PM ET
    • The Long-Term Effects of Fenfluramine on Patients with Dravet Syndrome and Their Families: A Qualitative Analysis

      Jensen, Salem, Gammaitoni et al

      Poster #418

      Authors available: Sunday, December 6, 12:00 – 1:30 PM ET
    • University of Washington Caregiver Stress Scale Translations

      Amtmann, Bamer, Salem et al

      Poster #287

      Authors available: Sunday, December 6, 12:00 – 1:30 PM ET
    • Fenfluramine (FINTEPLA) in Dravet Syndrome: Results of a Third Randomized, Placebo-Controlled Clinical Trial

      Sullivan, Lagae, Cross et al

      Poster #853

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Efficacy and Tolerability with FINTEPLA (Fenfluramine) in Adult Patients with Dravet Syndrome: A Case Series of Patients Participating in Phase 3 Studies

      Miller, Devinsky, Auvin et al

      Poster #849

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Fenfluramine for the Treatment of Patients with Lennox-Gastaut Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

      Knupp, Lagae, Arzimaniglou et al

      Poster #852

      Authors available: Monday, December 7, 9:00 – 10:30 AM ET
    • Fenfluramine to Treat Convulsive Seizures in Patients with CDKL5 Deficiency Disorder

      Devinsky, King, and Price

      Poster #1060

      Authors available: Monday, December 7, 1:303:00 PM ET

    Scientific Exhibit Room

    All posters from the main conference above, plus the two additional Scientific Exhibit Room posters, will be available in the Zogenix Scientific Exhibit Room. Questions regarding data in the Scientific Exhibition Room will be answered during a live discussion on Sunday, December 6, from 8:00 – 11:00 a.m. Eastern Time.

    • Impact of FINTEPLA (Fenfluramine) on the Incidence Rate of SUDEP in Patients with Dravet Syndrome

      Cross, Galer, Gil-Nagel et al
    • Fenfluramine Prevents Audiogenic Seizures in a 129/SvTer Mouse Model of Sudden Unexpected Death in Epilepsy (SUDEP)

      Martin, Biraben, Harnandez et al

    Satellite Symposium:

    Zogenix is proud to sponsor the Industry CME Satellite Symposium: An Update on Rare Childhood-Onset Epilepsies, which will be held on Sunday, December 6, from 6:00 – 7:30 p.m. Eastern Time with the following speakers and topics:

    • Epileptic Encephalopathies: Phenotypic Evolution

      Elaine Wirrell, M.D., FRCPC (Program Chair)
    • Mechanisms of Epileptogenesis in a Zebrafish Model of Dravet Syndrome

      Camila V. Esguerra, Ph.D.,
    • An Update on Sunflower Syndrome: Clinical Features and Treatment Challenges

      Elizabeth Thiele, M.D., Ph.D.
    • An Update on CDKL5 Deficiency Disorder: Clinical Presentations, Genetic Variation, and Approaches to Treatment

      Orrin Devinsky, M.D.

    About Dravet Syndrome

    Dravet syndrome is a rare and devastating infant-onset epilepsy highly correlated with a mutation in the SCN1A gene. The disease is marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death (SUDEP). In addition to its impact on the patient, the severity and unpredictability of the disease, coupled with around-the-clock concern for the diagnosed child's well-being, can present significant emotional and logistical challenges for all members of the family.

    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 CDKL5 Deficiency Disorder

    CDKL5 deficiency disorder is a rare developmental epileptic encephalopathy caused by mutations in the CDKL5 gene. The hallmarks are early-onset, intractable epilepsy and neurodevelopmental delay impacting cognitive, motor, speech, and visual function. Although rare, it one of the most common forms of genetic epilepsy.

    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 5HT2B 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, C-IV is approved by the U.S. FDA, has received positive CHMP opinion in Europe, and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, devastating infant-onset epilepsy. FINTEPLA is also in development for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare and devastating childhood-onset epilepsy. Through its subsidiary Modis Therapeutics, Zogenix is developing MT1621, an investigational novel deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.

    Forward Looking Statements

    Zogenix cautions you that statements included in this press release and the poster presentations 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 development plans for FINTEPLA in Lennox-Gastaut syndrome (LGS) and CDKL5 deficiency disorder and for MT1621, and the potential clinical value that FINTEPLA provides for Dravet syndrome, LGS and CDKL5 deficiency disorder patients and their families. 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: the timing of enrollment or results of Zogenix's clinical trials; the COVID-19 pandemic may disrupt Zogenix's business operations, impairing the ability to complete the planned studies of 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 reported for Dravet syndrome or other indications; 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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  2. EMERYVILLE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, and Treasurer, will participate in a fireside chat on Wednesday, November 18, 2020, at the Stifel 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details 
    Date: Wednesday, November 18, 2020
    Time: 10:00 AM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    About Zogenix

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

    EMERYVILLE, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, and Treasurer, will participate in a fireside chat on Wednesday, November 18, 2020, at the Stifel 2020 Virtual Healthcare Conference.

    Zogenix Fireside Chat Details 
    Date: Wednesday, November 18, 2020
    Time: 10:00 AM Eastern Time

    The fireside chat will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com.

    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 received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.  

    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

    View Full Article Hide Full Article
    • FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program

    • More than 300 patients prescribed FINTEPLA and enrolled in the FINTEPLA REMS program in the third quarter; over half of the patients were new to FINTEPLA
       
    • Received a positive opinion from the Committee for Medicinal Products for Human Use for FINTEPLA in Dravet syndrome; European approval of the Marketing Authorization Application anticipated by the end of 2020

    • Announced highly positive top-line results from third Phase 3 trial of FINTEPLA in Dravet syndrome (Study 3) to support a planned submission of a Japan New Drug Application in
    • FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program



    • More than 300 patients prescribed FINTEPLA and enrolled in the FINTEPLA REMS program in the third quarter; over half of the patients were new to FINTEPLA

       
    • Received a positive opinion from the Committee for Medicinal Products for Human Use for FINTEPLA in Dravet syndrome; European approval of the Marketing Authorization Application anticipated by the end of 2020



    • Announced highly positive top-line results from third Phase 3 trial of FINTEPLA in Dravet syndrome (Study 3) to support a planned submission of a Japan New Drug Application in the third quarter of 2021

       
    • Ended the third quarter with $525 million in cash, cash equivalents, and marketable securities

    EMERYVILLE, Calif. , Nov. 09, 2020 (GLOBE NEWSWIRE) --  Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2020 and provided a corporate update. The Company will host a conference call today, Monday, November 9, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

    "This continues to be a very positive and rewarding year for Zogenix as our deeply experienced international teams successfully advance key clinical, regulatory, and commercial programs," said Stephen J. Farr, Ph.D., President and CEO of Zogenix. "The strong physician and patient adoption of FINTEPLA® in this early stage of our U.S. launch and the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) speak to FINTEPLA's effectiveness, safety, and potential to provide meaningful and lasting seizure control for more Dravet syndrome patients. This increases our excitement for our next set of major FINTEPLA milestones – anticipated approval for Dravet syndrome in Europe later this year, regulatory submission for Dravet syndrome in Japan next year, and regulatory submissions for Lennox-Gastaut syndrome (LGS) in the U.S. and Europe, also next year."

    "Equally important," said Dr. Farr, "following a productive meeting with the U.S. Food and Drug Administration (FDA), we believe we have a clearly defined development and regulatory path for MT1621, our late-stage investigational therapy for the treatment of the often-fatal mitochondrial disease thymidine kinase 2 deficiency (TK2d), for which no approved therapies currently exist. Our goal is to have all required data in hand by the end of 2021 to enable a planned New Drug Application (NDA) submission in 2022."

    Corporate Update

    • FINTEPLA for the treatment of seizures associated with Dravet syndrome:



      °  Received FDA approval on June 25, 2020 and initiated U.S. commercial launch on July 27, 2020



      °  More than 360 prescribers had successfully completed Risk Evaluation and Mitigation Strategy (REMS) certification process by the end of September



      °  During the third quarter, more than 300 patients were prescribed FINTEPLA and enrolled in the FINTEPLA REMS program to become eligible to receive therapy, with approximately 90% completing echocardiograms. More than half of these patients were new to FINTEPLA.



      °  Received positive CHMP opinion in October 2020 for FINTEPLA in Dravet syndrome; anticipate European Medicines Agency approval by the end of 2020, and have ramped up preparations for a potential commercial launch in Europe in the first quarter of 2021



      °  Announced positive top-line results from third multinational (including Japan) Phase 3 study in Dravet syndrome; results corroborate highly statistically significant reductions in convulsive seizure frequency seen in two earlier Phase 3 studies of FINTEPLA in Dravet. Anticipate submission of a Japan NDA to Japan's Pharmaceutical and Medical Devices Agency in the third quarter of 2021
    • FINTEPLA for the treatment of seizures associated with LGS:



      °  Anticipate submitting supplemental NDA in the second quarter of 2021 following a successful Type C meeting in September clarifying regulatory path



      °  Anticipate submitting MAA with EMA in the third quarter of 2021



    • MT1621 for the treatment of TK2d:



      °  Recently held positive FDA meetings to discuss development path and data required to support planned NDA submission



      °  Company expects availability of all required data by end of 2021, and anticipates the submission of an NDA in first half of 2022

    Third Quarter 2020 Financial Results

    • The Company recorded $2.9 million in revenue for the third quarter ended September 30, 2020. This included product sales of FINTEPLA in the U.S. of  $1.5 million, in addition to $1.4 million in 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 $0.6 million in revenue for the corresponding period of 2019.



    • Research and development expenses for the third quarter ended September 30, 2020, totaled $34.4 million, up from $28.4 million in the third quarter ended September 30, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.



    • Selling, general and administrative expenses for the third quarter ended September 30, 2020, totaled $24.6 million, compared with $15.8 million in the third quarter ended September 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for potential launch in Europe.



    • Net loss for the third quarter ended September 30, 2020, was $60.1 million, or a net loss of $1.08 per share, compared with a net loss of $290.5 million, or a net loss of $6.75 per share, in the third quarter ended September 30, 2019. Net loss for the three months ended September 30, 2019, included $249.4 million of acquired in-process research and development consisting of existing research and development projects at the time of the Modis acquisition.     

    Nine Months Ended September 30, 2020 Financial Results Compared to Nine Months Ended September 30, 2019

    • The Company recorded $5.1 million in revenue for the nine months ended September 30, 2020. This included product sales of FINTEPLA in the U.S. of $1.5 million, in addition to $3.6 million in 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 $1.7 million in revenue for the corresponding period of 2019.



    • Research and development expenses for the nine months ended September 30, 2020, totaled $102.0 million, up from $79.8 million in the nine months ended September 30, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.



    • Selling, general and administrative expenses for the nine months ended September 30, 2020, totaled $70.3 million, up from $42.1 million in the nine months ended September 30, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.



    • Net loss for the nine months ended September 30, 2020, was $139.2 million, or a net loss of $2.62 per share, compared with a net loss of $363.4 million, or a net loss of $8.54 per share, in the nine months ended September 30, 2019.



    • As of September 30, 2020, the Company had $525.2 million in cash, cash equivalents, and marketable securities, reflecting the issuance of a $200 million convertible bond on September 28, 2020, compared to $251.2 million at December 31, 2019.

    Conference Call

    Monday, November 9 at 4:30 PM Easter Time / 1:30 PM Pacific Time

    Toll Free:                     877-407-9716
    International:               201-493-6779
    Conference ID:           13711927
    Webcast:                     http://public.viavid.com/index.php?id=141969

    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 received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company. 

    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 potential that FINTEPLA, if approved by the EC, will be an important new treatment option for Dravet syndrome patients; and the timing and results of any decision regarding the MAA for FINTEPLA for the treatment of seizures associated with Dravet syndrome. 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: the EC may not agree with the Company's interpretation of the clinical data submitted in the MAA; the EC may not affirm the CHMP opinion and grant a centralized marketing authorization; additional data from Zogenix's ongoing studies may contradict or undermine the data submitted in the Dravet syndrome MAA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or 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

    Zogenix, Inc.

    Condensed Consolidated Balance Sheets (Unaudited)

    (in thousands)

     September 30, 2020 December 31, 2019
    Assets:   
    Current assets:   
    Cash and cash equivalents$297,460  $62,070 
    Marketable securities227,707  189,085 
    Accounts receivable, net1,309   
    Inventory1,010   
    Prepaid expenses and other current assets12,905  11,084 
    Acquisition holdback placed in escrow25,000  25,000 
    Total current assets565,391  287,239 
    Property and equipment, net9,050  9,424 
    Operating lease right-of-use assets8,002  7,774 
    Intangible asset, net100,529  102,500 
    Goodwill6,234  6,234 
    Other noncurrent assets2,840  1,079 
    Total assets$692,046  $414,250 
    Liabilities and stockholders' equity:   
    Current liabilities:   
    Accounts payable$7,223  $7,979 
    Accrued and other current liabilities31,882  30,117 
    Acquisition holdback liability24,444  24,444 
    Deferred revenue, current4,900  5,927 
    Current portion of operating lease liabilities1,654  1,322 
    Current portion of contingent consideration22,200  25,600 
    Total current liabilities92,303  95,389 
    Deferred revenue, noncurrent6,331  7,425 
    Operating lease liabilities, net of current portion10,660  10,752 
    Contingent consideration, net of current portion32,700  38,200 
    Convertible senior notes127,960   
    Deferred tax liability  17,425 
    Total liabilities269,954  169,191 
    Commitments and contingencies   
    Stockholders' equity:   
    Common stock56  45 
    Additional paid-in capital1,676,408  1,360,092 
    Accumulated deficit(1,254,670) (1,115,457)
    Accumulated other comprehensive income298  379 
    Total stockholders' equity422,092  245,059 
    Total liabilities and stockholders' equity$692,046  $414,250 

    Zogenix, Inc.

    Condensed Consolidated Statements of Operations (Unaudited)

    (in thousands, except per share amounts)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Revenues:       
    Net product sales$1,520  $  $1,520  $ 
    Collaboration revenue1,340  630  3,621  1,699 
    Total revenues2,860  630  5,141  1,699 
    Costs and expenses:       
    Cost of product sales (excluding amortization of intangible asset)140    140   
    Research and development34,425  28,372  102,038  79,820 
    Selling, general and administrative24,583  15,762  70,332  42,139 
    Amortization of intangible asset1,971    1,971   
    Acquired in-process research and development and acquisition-related costs1,500  249,437  4,500  249,437 
    Change in fair value of contingent consideration1,800  400  6,100  2,700 
    Total costs and expenses64,419  293,971  185,081  374,096 
    Loss from operations(61,559) (293,341) (179,940) (372,397)
    Other income, net934  481  20,798  433 
    Interest income, net536  2,382  2,504  8,521 
    Loss before income taxes(60,089) (290,478) (156,638) (363,443)
    Income tax benefit    (17,425)  
    Net loss$(60,089) $(290,478) $(139,213) $(363,443)
            
    Net loss per share, basic and diluted$(1.08) $(6.75) $(2.62) $(8.54)
            
    Weighted average number of shares used in the calculation of basic and diluted net loss per common share55,548  43,029  53,039  42,577 

     

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  3. EMERYVILLE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it has changed the date of its previously announced earnings release and earnings call. The Company will now report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Monday, November 9, 2020, at 4:30 PM Eastern Time.

    Conference Call Details
    Monday, November 9, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:

    http://public.viavid.com/index.php?id=141969

    About Zogenix
    Zogenix is a global biopharmaceutical…

    EMERYVILLE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it has changed the date of its previously announced earnings release and earnings call. The Company will now report its financial results for the three and nine months ended September 30, 2020 and host a corporate update conference call and webcast after the market close on Monday, November 9, 2020, at 4:30 PM Eastern Time.

    Conference Call Details

    Monday, November 9, at 4:30 PM Eastern Time / 1:30 PM Pacific Time

    Toll Free:877-407-9716
    International:201-493-6779
    Conference ID:13711927
    Webcast:



    http://public.viavid.com/index.php?id=141969



    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 received a positive CHMP opinion in Europe for the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a different rare childhood-onset epilepsy and another for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder. MT1621 is being developed through Modis Therapeutics, a Zogenix company.

    Zogenix 

    Melinda Baker 

    Senior Director, Corporate Communications 

    +1 (510) 788-8732 |  

    Investors 

    Brian Ritchie 

    Managing Director, LifeSci Advisors LLC 

    +1 (212) 915-2578 |  

    Media 

    In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli

    +44 (0) 7949 794 290 |

    In the US: Stefanie Tuck, Vice President, Porter Novelli

    +1 (978) 390-1394 |

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