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UCB has successfully completed its acquisition of Zogenix for US$ 26.00 per share, valuing the total transaction at approximately US$ 1.9 billion. This includes a milestone-based contingent value right for an additional US$ 2.00 per share. The merger will make Zogenix a wholly-owned subsidiary of UCB, leading to its delisting from NASDAQ. UCB anticipates immediate revenue contributions from the acquisition in 2022, while expecting it to become earnings accretive starting in 2023. Zogenix's FINTEPLA® aims to enhance treatment for Dravet syndrome and other indications.
Zogenix (Nasdaq: ZGNX) announced new findings on FINTEPLA’s safety and efficacy for Lennox-Gastaut syndrome (LGS) at the American Academy of Neurology (AAN) Annual Meeting 2022. Presentations include long-term cardiovascular safety data and a study showing improved executive function in LGS patients. LGS affects 30,000-50,000 patients in the U.S. FINTEPLA is FDA-approved for Dravet syndrome and under review for LGS. The meeting will occur in Seattle from April 2-7, 2022, with virtual sessions later in April. More details are available on Zogenix's newsroom.
Immunicom, a clinical-stage biotechnology company, has appointed Jennifer “J.D.” Haldeman as Vice President of Commercial Operations. Haldeman brings extensive experience from her previous roles in biopharma and diagnostics, including a leadership position at Zogenix (ZGNX). Her focus will be on global commercialization efforts for Immunicom's innovative Immunopheresis therapy, designed to enhance immune health in cancer patients. This therapy utilizes the LW-02 Column to target cancer defense mechanisms, aiming to improve patient outcomes while minimizing side effects.
Zogenix reported total revenue of $26.6 million for Q4 2021, including $23.5 million from FINTEPLA. For the full year, revenue reached $81.7 million, with FINTEPLA sales of $74.7 million. The FDA accepted a supplemental New Drug Application for FINTEPLA in Lennox-Gastaut Syndrome, and the company submitted a Type II variation application to the EMA. Zogenix is set to be acquired by UCB, with a transaction valued at up to $1.9 billion, indicating a 72% premium on ZGNX shares. The net loss for 2021 was $227.4 million.
Zogenix (NASDAQ: ZGNX) has launched a no-cost genetic testing program in collaboration with the United Mitochondrial Disease Foundation (UMDF) and Probably Genetic. This initiative aims to assist patients suspected of having mitochondrial diseases, particularly TK2 deficiency. The program allows eligible U.S. patients to access genetic testing and counseling at no cost, expediting diagnosis and treatment pathways. TK2 deficiency is a severe condition resulting in muscle weakness, and Zogenix is also developing an investigational therapy, MT1621, for this rare disease.
Brodsky & Smith has initiated investigations concerning Zogenix, Inc. (ZGNX), Social Capital Suvretta Holdings Corp. III (DNAC), and Viveon Health Acquisition Corp. (VHAQ) due to potential breaches of fiduciary duties by their boards during acquisition agreements. Zogenix is proposed to be acquired by UCB for $26.00 per share, plus a $2.00 CVR. Social Capital's merger with ProKidney results in a 9% ownership for its shareholders. Viveon Health's merger with Suneva Medical will leave its shareholders with 39.3% ownership. These investigations assess fairness in the acquisition processes.
UCB has announced a definitive agreement to acquire Zogenix for US$ 26.00 per share, totaling approximately US$ 1.9 billion. The transaction includes a potential cash payment of US$ 2.00 upon EU approval of FINTEPLA® for treating Lennox-Gastaut syndrome (LGS) by December 31, 2023. This acquisition aims to enhance UCB's portfolio in rare epilepsy treatments, particularly for conditions like Dravet syndrome. Both companies' boards have unanimously approved the transaction, which is expected to close by mid-2022, pending regulatory approvals.
Zogenix announced the submission of a New Drug Application (J-NDA) to Japan’s Ministry of Health for FINTEPLA® (fenfluramine) to treat Dravet syndrome-related seizures. The application is backed by Study 3 results, showing a 64.8% greater reduction in monthly seizures compared to placebo. FINTEPLA received Orphan Drug Designation in Japan in August 2021. If approved, it will be marketed through an exclusive agreement with Nippon Shinyaku. Dravet syndrome, affecting an estimated 3,000 patients in Japan, causes frequent seizures and significant quality-of-life issues.
Zogenix (Nasdaq: ZGNX) announces the submission of its Type II Variation Marketing Authorization Application to the EMA for FINTEPLA® to treat seizures associated with Lennox-Gastaut syndrome (LGS). This marks a significant milestone, enhancing FINTEPLA's application beyond Dravet syndrome. Supported by data from a Phase 3 trial with 263 patients, FINTEPLA showed a statistically significant reduction in drop seizure frequency. The FDA has also accepted Zogenix’s supplemental NDA for FINTEPLA for LGS with Priority Review. LGS affects an estimated 20,000-30,000 patients in the EU, highlighting the need for effective treatments.
Zogenix (ZGNX) announced on December 15, 2021, that its compensation committee granted inducement awards to nine new non-executive employees. These awards include options to purchase 84,400 shares of common stock at an exercise price of $13.32, with a vesting period of four years. Additionally, 17,300 restricted stock units will vest in four equal annual installments, starting from the first anniversary of the commencement date. This initiative aims to attract talent under the company’s 2021 Employment Inducement Equity Incentive Award Plan.