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Zogenix, Inc. (NASDAQ: ZGNX) announced that the FDA has approved FINTEPLA (fenfluramine) oral solution for treating seizures associated with Dravet syndrome in patients aged 2 and older. This approval marks a crucial milestone for patients suffering from this severe epilepsy, with FINTEPLA expected to launch by the end of July through a restricted distribution program. The approval is supported by data from Phase 3 clinical trials, demonstrating significant reductions in convulsive seizure frequency when added to existing treatments. The company also introduced Zogenix Central, a support service for patients and caregivers.
Zogenix announced FDA approval for FINTEPLA® (fenfluramine) oral solution, designated for treating Dravet syndrome seizures in patients aged 2 and older. This approval, based on two Phase 3 clinical trials showing significant seizure reduction, marks a pivotal milestone for patients with this rare childhood epilepsy. FINTEPLA is set for commercial launch by the end of July 2020, under a restricted distribution program. The approval highlights the unmet need in Dravet syndrome treatment, promising a new option for patients with inadequate control on existing medications.
Zogenix has launched new resources in the U.S. for siblings of children living with Dravet syndrome, aiming to address their emotional and mental health needs. Developed with the Dravet Syndrome Foundation and mental health experts, the materials include support guides, customizable sheets for teachers, and a VIP sibling kit with journals and stress relief items. These initiatives highlight the impact of Dravet syndrome on families and were introduced during a webinar. The resources will be available through the Dravet Syndrome Foundation starting August 1, 2020.
Zogenix, a global pharmaceutical company, launched Shine Forward with Dravet, an online platform offering resources for families dealing with Dravet syndrome. This childhood-onset epilepsy causes severe seizures and developmental challenges. The initiative aims to foster connections among parents and siblings by providing tips, coping strategies, and activities through its website and Facebook page. Zogenix emphasizes community collaboration in developing this resource, addressing the emotional and logistical challenges faced by affected families. This launch reinforces Zogenix's commitment to rare disease therapies.
Zogenix announced that Dr. Stephen J. Farr will participate in a fireside chat at the BofA Securities 2020 Virtual Healthcare Conference on May 13, 2020, at 3:00 PM Eastern Time. This event will be webcast live and archived for 90 days on Zogenix's Investor Relations website. The company is focused on developing therapies for rare diseases, including FINTEPLA® for Dravet and Lennox-Gastaut syndromes and MT1621 for TK2 deficiency.
Zogenix, Inc. (Nasdaq: ZGNX) reported financial results for Q1 2020, recording $1.2 million in revenue, a notable increase from $0 in Q1 2019, largely due to its collaboration with Nippon Shinyaku for FINTEPLA in Japan.
The company announced a net loss of $25.8 million, improved from $35.2 million in the prior year, as R&D and SG&A expenses rose to $33.2 million and $21.3 million, respectively. Zogenix anticipates a PDUFA date of June 25, 2020, for FINTEPLA's approval for Dravet syndrome and plans to meet with the FDA for an sNDA submission for Lennox-Gastaut syndrome.