Welcome to our dedicated page for ZGNX news (Ticker: ZGNX), a resource for investors and traders seeking the latest updates and insights on ZGNX stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect ZGNX's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of ZGNX's position in the market.
Zogenix (NASDAQ: ZGNX) announced a positive opinion from the CHMP, recommending the marketing authorization of FINTEPLA® (fenfluramine) for treating seizures in Dravet syndrome patients aged two and older. The recommendation is based on Phase 3 study results showing significant reductions in convulsive seizure frequency when used as an add-on therapy. A final decision from the European Commission is anticipated by year-end 2020. FINTEPLA has already received FDA approval in the U.S., with ongoing studies supporting registration in Japan.
Zogenix, Inc. (Nasdaq: ZGNX) shared significant findings from an open-label extension trial of FINTEPLA® (fenfluramine) for Dravet syndrome at CNS/ICNA 2020. The interim data indicated that substantial seizure reductions were maintained for up to two years. A post-hoc analysis revealed favorable Number Needed to Treat (NNT) for achieving ≥75% seizure reduction compared to other therapies for Dravet syndrome. FINTEPLA is FDA-approved, under European review, and in development for Lennox-Gastaut syndrome treatment. These results underscore FINTEPLA's clinical value for patients and families affected by Dravet syndrome.
Zogenix, Inc. (Nasdaq: ZGNX) has successfully closed a private offering of an additional $30 million of its 2.75% convertible senior notes due 2027, bringing the total outstanding amount to $230 million. The net proceeds, approximately $222.7 million after expenses, will primarily support the development of Fintepla for Dravet syndrome and Lennox-Gastaut syndrome, as well as MT1621 for TK2 deficiency. This offering follows the original notes sale on September 28, 2020, and is aimed at financing critical programs in rare disease therapies.
Zogenix, a biopharmaceutical firm, presented new data on MT1621, its investigational therapy for Thymidine kinase 2 deficiency (TK2d), at the World Muscle Society Congress 2020. This genetic disorder primarily affects infants and leads to severe health complications. Dr. Joanne Quan emphasized the urgent need for TK2d therapies, highlighting progress in the MT1621 development program. Key presentations covered the mechanism of action, morbidity analysis in untreated patients, and a protocol for a prospective clinical study. There are currently no approved treatments for TK2d, marking MT1621 as a significant potential intervention.
Zogenix, Inc. (Nasdaq: ZGNX) has priced an offering of $200 million in 2.75% convertible senior notes due 2027, set to settle on September 28, 2020. The notes are senior, unsecured obligations and will accrue interest payable semi-annually. The initial conversion price is about $24.28 per share, representing a 30% premium over the last traded price of $18.68. Net proceeds are estimated at $193.6 million, aimed to support the development of Fintepla for seizure disorders and MT1621 for TK2 deficiency. The offering is exempt from registration under securities laws.
Zogenix plans to offer $200 million in convertible senior notes due 2027, with an option for an additional $30 million. The notes are unsecured, will accrue interest payable semi-annually, and can be converted under certain conditions. Proceeds will fund development of Fintepla for Dravet and Lennox-Gastaut syndromes and MT1621 for TK2 deficiency, alongside general corporate purposes. The offering will comply with Rule 144A of the Securities Act and is not registered. The completion and size of the offering depend on market conditions and other factors.
Zogenix (Nasdaq: ZGNX) has announced the appointment of three new members—Caroline M. Loewy, Mary E. Stutts, and Denelle J. Waynick—to its Board of Directors, expanding the board to 10 members, with 9 being independent. The new directors bring extensive experience in biopharmaceuticals, patient advocacy, and corporate communications. Their expertise is expected to support Zogenix's growth as a commercial-stage rare disease company, particularly in developing therapies like their approved drug, FINTEPLA, for severe childhood epilepsy.
Zogenix reported positive results from its Phase 3 study of FINTEPLA (fenfluramine) for treating Dravet syndrome, demonstrating a 64.8% reduction in monthly convulsive seizures (p<0.0001) at 0.7 mg/kg/day and 49.9% at 0.2 mg/kg/day (p<0.0001) compared to placebo. This trial supports the upcoming Japanese new drug application (J-NDA) submission planned for 2021. With FINTEPLA already available in the U.S. and under review in Europe, Zogenix aims to expand access to this effective treatment globally.
Zogenix, a global pharmaceutical company, will announce its financial results for Q2 2020 on August 5, 2020, at 4:30 PM ET. The company is focused on developing therapies for rare diseases, with its approved product FINTEPLA for treating Dravet syndrome and ongoing late-stage programs for Lennox-Gastaut syndrome and TK2 deficiency. The conference call will be accessible through toll-free and international numbers, alongside a webcast link.
