TK2

Zogenix To Present New Long-term Data on FINTEPLA® (fenfluramine) in Lennox-Gastaut Syndrome (LGS) at AAN 2022

Retrieved on: 
Friday, March 4, 2022
CDD, New Drug Application, TK2, Mitochondrial disease, COVID-19, 2021 Essex County Council election, Lennox–Gastaut syndrome, Physician, European, Private Securities Litigation Reform Act, Falls, Life, UCB, European Medicines Agency, FDA, Epilepsy, Even and odd functions, Caregiver, REMS, Review, LGS, Degenerative disease, American Academy, Food, U.S. Securities and Exchange Commission, AAN, American Academy of Neurology, Priority review, Seizure, Syndrome, Shanda, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Behavior, Research, Injury, Dravet syndrome, GLOBE, Pharmaceutical industry, Fenfluramine, Patient

Fenfluramine Improves Everyday Executive Functioning in Patients With Lennox-Gastaut Syndrome: Analysis of Phase 3 Data

Key Points: 
  • Fenfluramine Improves Everyday Executive Functioning in Patients With Lennox-Gastaut Syndrome: Analysis of Phase 3 Data
    The abstracts being presented are available on the AAN website and will be available following the meeting on the Zogenix Newsroom site.
  • Lennox-Gastaut Syndrome is a rare and devastating lifelong childhood-onset epilepsy that can arise from multiple different causes.
  • FINTEPLA is also being investigated as a potential treatment for Lennox-Gastaut syndrome (LGS) and other rare and severe childhood-onset epilepsy disorders.
  • This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Zogenix Supports New No-Cost Genetic Testing Program with United Mitochondrial Disease Foundation to Improve Diagnosis of Mitochondrial Diseases

Retrieved on: 
Tuesday, February 15, 2022
Epilepsy, Tissue, European Medicines Agency, Genetic testing, CDD, Private Securities Litigation Reform Act, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, REMS, U.S. Securities and Exchange Commission, Lennox–Gastaut syndrome, Degenerative disease, COVID-19, Caregiver, Dravet syndrome, New Drug Application, Invitae, UCB, Mitochondrial disease, UMDF, Patient, Shanda, Awareness, Seizure, Cell, Fenfluramine, Genetic disorder, Partnership, Diagnosis, NASDAQ, Priority review, Movement, Review, Muscle weakness, Alliance, Disease, Program, GLOBE, Quality of life, Food, TK2, Eating, Genetic counseling, FDA, LGS, Physician, Medical imaging, Pharmaceutical industry, EU, Science

The program is available to any eligible patient in the U.S. with a suspected diagnosis of mitochondrial disease.

Key Points: 
  • The program is available to any eligible patient in the U.S. with a suspected diagnosis of mitochondrial disease.
  • The UMDF Pilot Genetic Testing Project will be a patient-initiated no-cost genetic testing program for patients with a suspected mitochondrial disorder.
  • The UMDF program will include testing for the TK2 gene.TK2d is a debilitating and life-threatening genetic disorder that causes progressive and severe muscle weakness.
  • Zogenix also recently partnered with Invitae to support its no-cost genetic testing program, called Detect Muscular Dystrophy, and continues to support a TK2d-specific genetic testing program through PreventionGenetics .

Zogenix Submits Type II Variation Application to the European Medicines Agency (EMA) to Expand the Use of FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome

Retrieved on: 
Monday, December 20, 2021
U.S. Securities and Exchange Commission, Food, Shanda, FDA, Falls, European Medicines Agency, Lennox–Gastaut syndrome, CDD, Life, New Drug Application, Epilepsy, Labour, Private Securities Litigation Reform Act, European Commission, COVID-19, EMA, Fenfluramine, Injury, Seizure, Review, Degenerative disease, TK2, File, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mitochondrial disease, Safety, Patient, Disease, Dravet syndrome, Priority review, REMS, GLOBE, MHLW, LGS, Pharmaceutical industry, Health

If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS.

Key Points: 
  • If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS.
  • We remain focused on working with the EMA to bring FINTEPLA for the treatment of seizures associated with LGS to market as quickly as possible in Europe.
  • In December 2021, the U.S. Food and Drug Administration (FDA) accepted Zogenixs supplemental New Drug Application (sNDA) and granted Priority Review for FINTEPLA for the treatment of seizures associated with LGS.
  • The Japanese Ministry of Health, Labour & Welfare (MHLW) has also granted Orphan Drug Designation to FINTEPLA for the treatment of seizures associated with Dravet syndrome, which Zogenix is developing in Japan.

Zogenix Reports Granting of Inducement Awards

Retrieved on: 
Thursday, December 16, 2021
Food, Shanda, FDA, Lennox–Gastaut syndrome, CDD, New Drug Application, Epilepsy, Fenfluramine, NASDAQ, Degenerative disease, TK2, File, Mitochondrial disease, Patient, Dravet syndrome, Seizure, Priority review, GLOBE, LGS, Health insurance, Pharmaceutical industry

EMERYVILLE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to nine (9) new non-executive employees.

Key Points: 
  • EMERYVILLE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to nine (9) new non-executive employees.
  • The awards were made on December 15, 2021, under Zogenixs 2021 Employment Inducement Equity Incentive Award Plan, which was approved by the companys board of directors under Nasdaq Marketplace Rule 5635(c)(4), for granting equity awards to new employees of Zogenix as an inducement to join the company.
  • The awards consist of options to purchase an aggregate of 84,400 shares of Zogenix common stock and 17,300 restricted stock units.
  • 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.

Zogenix Announces U.S. FDA Acceptance for Priority Review of Supplemental New Drug Application for FINTEPLA® (Fenfluramine) for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)

Retrieved on: 
Wednesday, December 1, 2021
Patient, Private Securities Litigation Reform Act, Fenfluramine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Review, Safety, European Medicines Agency, LGS, Disease, Falls, Shanda, Mitochondrial disease, Diagnosis, Seizure, Priority review, Lennox–Gastaut syndrome, COVID-19, Physician, New Drug Application, GLOBE, CDD, PDUFA, TK2, Injury, File, Dravet syndrome, United, FDA, REMS, U.S. Securities and Exchange Commission, Epilepsy, NASDAQ, Life, Degenerative disease, Food, Pharmaceutical industry

FDA Priority Review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.

Key Points: 
  • FDA Priority Review is granted for investigational therapies that, if approved, may offer significant improvements in the treatment, prevention or diagnosis of a serious condition.
  • We look forward to working closely with the FDA to potentially bring FINTEPLA for the treatment of seizures associated with LGS to market as quickly as possible.
  • In June 2020, FINTEPLA was approved by the FDA for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.
  • In Japan,Zogenixis on track to submit a new drug application (J-NDA) for FINTEPLA for the treatment of seizures associated with Dravet syndrome in late 2021.

Zogenix Reports Granting of Inducement Awards

Retrieved on: 
Wednesday, November 17, 2021
Patient, Fenfluramine, European Medicines Agency, Mitochondrial disease, Seizure, Lennox–Gastaut syndrome, GLOBE, CDD, TK2, Dravet syndrome, FDA, Epilepsy, NASDAQ, Degenerative disease, Pharmaceutical industry

EMERYVILLE, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to thirteen (13) new non-executive employees.

Key Points: 
  • EMERYVILLE, Calif., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to thirteen (13) new non-executive employees.
  • The awards were made on November 15, 2021, under Zogenixs 2021 Employment Inducement Equity Incentive Award Plan, which was approved by the companys board of directors under Nasdaq Marketplace Rule 5635(c)(4), for granting equity awards to new employees of Zogenix as an inducement to join the company.
  • The awards consist of options to purchase an aggregate of 41,130 shares of Zogenix common stock and 21,040 restricted stock units.
  • 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.

Zogenix to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Thursday, November 11, 2021
Seizure, CDD, TK2, Epilepsy, Dravet syndrome, European Medicines Agency, Degenerative disease, Lennox–Gastaut syndrome, Mitochondrial disease, Fenfluramine, Patient, FDA, Pharmaceutical industry

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.

Key Points: 
  • 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 companys 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 also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

Zogenix to Host Key Opinion Leader Webinar on Thymidine Kinase 2 Deficiency and MT-1621

Retrieved on: 
Monday, November 1, 2021
Myopathy, CDD, European Medicines Agency, Complutense University of Madrid, Natural history, Peaceful transition of power, Clinical trial, Columbia University, Albert Einstein College of Medicine, Publication, Research institute, Division, GLOBE, Degenerative disease, Research, Molecular biology, Children's Medical Research Institute, TK2, Epilepsy, KOL, Montreal Neurological Institute and Hospital, Columbia University Irving Medical Center, Pyrimidine, Lennox–Gastaut syndrome, Lucy, Continuation, Q&A, ALS, Seizure, DNA, Fenfluramine, Dravet syndrome, Neurological Institute of New York, NASDAQ, FDA, Neuromuscular medicine, Mitochondrial disease, Muscle, Pharmaceutical industry

EMERYVILLE, Calif., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will host a key opinion leader (KOL) webinar on thymidine kinase 2 deficiency (TK2d) and MT-1621 on Monday, November 8, 2021, at 12:00 PM Eastern Time.

Key Points: 
  • EMERYVILLE, Calif., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that it will host a key opinion leader (KOL) webinar on thymidine kinase 2 deficiency (TK2d) and MT-1621 on Monday, November 8, 2021, at 12:00 PM Eastern Time.
  • Dr. Galer will discuss the ongoing late-stage MT-1621 clinical program and remaining pathway to regulatory submissions.
  • She holds a doctorate from the Complutense University of Madrid with the thesis entitled: "Application of Personalized Medicine in Mitochondrial Pathology: treatment with pyrimidine nucleosides in thymidine kinase 2 deficiency (TK2d)".
  • 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 to Release Third Quarter 2021 Financial Results and Host Conference Call and Webcast on November 4

Retrieved on: 
Thursday, October 21, 2021
Fenfluramine, Dravet syndrome, CDD, European Medicines Agency, Patient, TK2, FDA, Lennox–Gastaut syndrome, Mitochondrial disease, Degenerative disease, Epilepsy, Seizure, Pharmaceutical industry

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.

Key Points: 
  • 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 companys 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 also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

Zogenix Reports Granting of Inducement Awards

Retrieved on: 
Tuesday, October 19, 2021
Lennox–Gastaut syndrome, NASDAQ, Mitochondrial disease, European Medicines Agency, CDD, Degenerative disease, Epilepsy, TK2, Dravet syndrome, FDA, GLOBE, Fenfluramine, Patient, Seizure, Pharmaceutical industry

EMERYVILLE, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to thirty-four (34) new non-executive employees.

Key Points: 
  • EMERYVILLE, Calif., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Zogenix(NASDAQ: ZGNX) today announced that the compensation committee of the companys board of directors granted inducement awards to thirty-four (34) new non-executive employees.
  • The awards were made on October 15, 2021, under Zogenixs 2021 Employment Inducement Equity Incentive Award Plan, which was approved by the companys board of directors under Nasdaq Marketplace Rule 5635(c)(4), for granting equity awards to new employees of Zogenix as an inducement to join the company.
  • The awards consist of options to purchase an aggregate of 75,480 shares of Zogenix common stock and 37,790 restricted stock units.
  • 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.