UCB has won FDA approval for Fintepla as a treatment seizures associated with rare childhood epilepsy Lennox-Gastaut Syndrome (LGS), raising the pressure on Jazz Pharma’s rival therapy Epidiolex.
Two podium and one poster presentation share important new findings on FINTEPLA’s safety profile and its impact on non-seizure related benefits for LGS patientsLGS is a debilitating childhood-onset...
Total revenue of $26.6 million in the Q4 and $81.7 million for the full yearFINTEPLA® net product sales of $23.5 million in the Q4 and $74.7 million for the full year Announced...
As the Belgian pharma UCB recently inked a $1.9 billion deal to buy out Zogenix and its top drug for epilepsy, the company’s former controversial opioid has now been pulled from the market, according to a Federal Register filing by the FDA on Tuesday.
Belgium's UCB on Wednesday said it has agreed to acquire Zogenix for as much as $1.9 billion in a deal centered around an epilepsy drug the California-based biotech brought to market 18 months ago.
EMERYVILLE, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Zogenix, a global biopharmaceutical company specializing in rare disease therapies, announced that it has submitted a New Drug Application (J-NDA) to the Japanese Ministry of Health, Labour & Welfare (MHLW) for the marketing approval of FINTEPLA® (fenfluramine) for the treatment of epileptic seizures associated with Dravet syndrome in Japan. FINTEPLA received Orphan Drug Designation from Japan’s Ministry of Health, Labour & Welfare (MHLW) in August 2021.
EMERYVILLE, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Zogenix (Nasdaq: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it has submitted its Type II Variation Market Authorization Application to the European Medicines Agency (EMA) for FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly treatment-resistant form of childhood-onset epilepsy. If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS.
Zogenix Reports Granting of Inducement Awards
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.
EMERYVILLE, Calif., Sept. 28, 2021 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it has submitted a supplemental New Drug Application (sNDA) for FINTEPLA® (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) to the U.S. Food and Drug Administration (FDA).