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Zogenix (NASDAQ: ZGNX) announced it will report its financial results for Q4 and full-year 2020 on February 25, 2021, at 4:30 PM ET. The company, based in Emeryville, California, focuses on developing therapies for rare diseases. Its lead product, FINTEPLA, is approved in the U.S. and Europe for treating Dravet syndrome. Zogenix is also advancing late-stage programs for seizures associated with Lennox-Gastaut syndrome and developing MT1621 for TK2 deficiency. A conference call will follow the earnings report to discuss the results.
Zogenix announced the availability of FINTEPLA (fenfluramine) oral solution in Germany for treating seizures associated with Dravet syndrome, a severe epilepsy affecting infants. Approved by the European Commission in December 2020, FINTEPLA can be prescribed as an add-on therapy for patients aged two and older. The treatment aims to reduce convulsive seizure frequency in patients not adequately controlled by existing medications. Safety studies showed significant seizure reductions but noted common side effects such as decreased appetite and diarrhea.
Zogenix (NASDAQ: ZGNX) reported preliminary, unaudited net product sales of approximately $8.1 million for FINTEPLA in Q4 2020. As of December 31, 2020, 492 healthcare providers completed the REMS certification for FINTEPLA, with over 550 patients prescribed and 416 receiving reimbursed therapy. The company maintains a strong cash position of approximately $505.8 million. Looking ahead, Zogenix plans to enhance U.S. adoption of FINTEPLA, launch in Europe, and expand patient eligibility for additional indications.
Zogenix announced that the European Commission has granted marketing authorization for FINTEPLA (fenfluramine) oral solution for treating convulsive seizures associated with Dravet syndrome in patients aged two years and older. The approval is based on positive Phase 3 study results indicating significant seizure reduction when added to existing medications. The launch is anticipated in Germany in Q1 2021. FINTEPLA will be available under a controlled access program to monitor safety and prevent off-label use. This therapy aims to provide new treatment options for patients suffering from this rare and severe epilepsy.
Tevard Biosciences and Zogenix (Nasdaq: ZGNX) are collaborating to develop tRNA-based gene therapies targeting Dravet syndrome and other genetic epilepsies. This partnership includes an initial payment of $10 million, with opportunities for additional milestone payments between $70 million to $100 million for each program. Zogenix will oversee the commercialization process, while Tevard will utilize its unique tRNA platforms for drug discovery. Both companies aim to address significant unmet medical needs in rare genetic disorders.
Zogenix (Nasdaq: ZGNX) announced new long-term safety and efficacy data for FINTEPLA® (fenfluramine) oral solution, specifically for Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies. These findings will be presented at the American Epilepsy Society Annual Meeting from December 4-8, 2020. Notably, Zogenix will host a virtual exhibition and a CME symposium. Chief Medical Officer Bradley Galer emphasized the collaboration with epilepsy experts to enhance treatment options for rare epilepsy disorders, highlighting the potential benefits for patients and families.
Zogenix, a biopharmaceutical company focused on rare disease therapies, announced that Stephen J. Farr, Ph.D., and Michael P. Smith will participate in a fireside chat at the Stifel 2020 Virtual Healthcare Conference on November 18, 2020, at 10:00 AM Eastern Time. The event will be streamed live and archived for 90 days on Zogenix's Investor Relations website. Zogenix is known for its FDA-approved therapy, FINTEPLA®, for Dravet syndrome and is developing additional treatments for other rare conditions.
Zogenix (NASDAQ: ZGNX) reported financial results for Q3 2020, with $2.9 million in revenue, including $1.5 million from FINTEPLA sales. Over 300 patients enrolled in the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program, with a significant number being new patients. The firm anticipates European approval for FINTEPLA by the end of 2020. R&D expenses rose to $34.4 million, reflecting growth in clinical activities, while net loss narrowed to $60.1 million. The company ended the quarter with $525 million in cash and equivalents, following a recent $200 million convertible bond issuance.
Zogenix, a biopharmaceutical company, announced a change in the date for its earnings release and conference call to November 9, 2020, at 4:30 PM ET. The company will report financial results for the three and nine months ended September 30, 2020. Zogenix is focused on developing therapies for rare diseases, with its leading product, FINTEPLA, approved for treating seizures associated with Dravet syndrome. The company has ongoing development programs for additional treatments for rare childhood-onset epilepsies and genetic disorders.
Zogenix, a biopharmaceutical company focused on rare disease therapies, will report its financial results for the third quarter of 2020 on November 10, 2020, at 4:30 PM ET. The company’s lead product, FINTEPLA, is approved for treating seizures in Dravet syndrome and is under development for other conditions. Zogenix is committed to transforming patient lives with innovative therapies. The conference call will offer insights into the company’s financial performance and ongoing projects.
