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Zogenix (Nasdaq: ZGNX) announced that new data regarding FINTEPLA (fenfluramine) for treating Dravet syndrome will be presented at the American Epilepsy Society (AES) Annual Meeting from December 3-7, 2021, in Chicago. This includes eight abstracts and four additional posters in a virtual exhibition. Positive efficacy and safety data were highlighted, including significant improvements in seizure frequency and executive function in preschool children. FINTEPLA is FDA-approved for Dravet syndrome and is also being investigated for Lennox-Gastaut syndrome.
Zogenix (NASDAQ: ZGNX) announced that the FDA accepted for filing its supplemental New Drug Application (sNDA) for FINTEPLA for treating seizures associated with Lennox-Gastaut syndrome (LGS), granting Priority Review. The PDUFA target action date is set for March 25, 2022. The sNDA is based on a positive Phase 3 trial showing FINTEPLA significantly reduced drop seizures in patients aged 2-35. Zogenix previously received FDA approval for FINTEPLA for Dravet syndrome. LGS affects 30,000 to 50,000 people in the U.S.
Zogenix announced the granting of inducement awards to thirteen non-executive employees on November 15, 2021. These awards, totaling options for 41,130 shares and 21,040 restricted stock units, aim to attract new talent under the company's 2021 Employment Inducement Equity Incentive Award Plan. The options have a ten-year term with an exercise price of $14.84 per share, vesting over four years. Zogenix focuses on developing therapies for rare diseases, notably with FINTEPLA, approved for seizures in Dravet syndrome and with programs in other rare conditions.
Zogenix (NASDAQ: ZGNX), a biopharmaceutical company, announced its participation in two investor conferences. Management will host fireside chats at the Guggenheim Virtual 3rd Annual Neuro/Immunology Conference on November 15, 2021, at 2:20 PM ET, and the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 1:20 PM ET. The chats will be webcast live and archived on Zogenix's Investor Relations website for 90 days. Zogenix develops therapies for rare diseases, including FINTEPLA® for Dravet syndrome and additional programs targeting various rare epilepsies.
Zogenix (NASDAQ: ZGNX) announced Q3 2021 financial results with total revenue of $22.6 million, up 20% quarter-over-quarter, driven by FINTEPLA sales of $21.4 million (up 22%). The company submitted a supplemental New Drug Application (sNDA) for FINTEPLA in Lennox-Gastaut Syndrome and continues late-stage development for FINTEPLA and MT1621. R&D expenses decreased to $26.3 million after a one-time charge of $7.0 million. However, net loss for the quarter stood at $58.0 million. As of September 30, 2021, cash reserves totaled $343.0 million.
Zogenix (NASDAQ: ZGNX) will host a KOL webinar on November 8, 2021, at 12 PM ET, focusing on thymidine kinase 2 deficiency (TK2d) and its investigational therapy MT-1621. Experts Cristina Dominguez-Gonzalez, M.D., and Michio Hirano, M.D., will discuss the disease's natural history along with ongoing clinical programs. Zogenix's management will review the late-stage program for MT-1621 and market opportunities. A Q&A session will follow the presentations. To register, click here.
Zogenix (NASDAQ: ZGNX) announced it will report its third-quarter financial results for the period ending September 30, 2021, on November 4, 2021, at 4:30 PM Eastern Time. A conference call will follow, providing updates on the company's ongoing research in rare diseases, including therapies for conditions like Dravet syndrome and Lennox-Gastaut syndrome. Zogenix has received approvals for its first therapy, FINTEPLA, in both the U.S. and Europe, with additional late-stage programs underway and plans for further research into genetic epilepsies.
Zogenix (NASDAQ: ZGNX) granted inducement awards to 34 new non-executive employees on October 15, 2021. These awards, part of the company’s Employment Inducement Equity Incentive Award Plan, include options for 75,480 shares and 37,790 restricted stock units. The options have a 10-year term with an exercise price of $15.77 and vest over four years. Zogenix is committed to developing therapies for rare diseases, with its first product FINTEPLA approved for Dravet syndrome and additional programs underway for other rare conditions.
Zogenix announced positive interim results from a Phase 3 clinical trial of FINTEPLA in treating drop seizures associated with Lennox-Gastaut syndrome (LGS). Key findings include a 39.4% median reduction in seizure frequency at 3 months and 51.8% at 10-12 months. The company submitted a Supplemental New Drug Application (sNDA) to the FDA for FINTEPLA's approval for LGS. The treatment was well-tolerated, with no observed valvular heart disease. Most patients (51.2%) showed a significant seizure reduction, demonstrating the drug's potential impact on this rare, severe epilepsy.
Zogenix has submitted a supplemental New Drug Application (sNDA) to the FDA for FINTEPLA® (fenfluramine) targeting seizures associated with Lennox-Gastaut Syndrome (LGS). This submission is backed by strong clinical data from its Phase 3 trial, where FINTEPLA significantly reduced drop seizure frequency in patients aged 2-35. LGS affects approximately 30,000-50,000 patients in the U.S., showcasing a critical unmet medical need. If approved, FINTEPLA may offer a new treatment option for this challenging condition, with ongoing safety data supporting its use.
