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Zogenix reported strong Q1 2021 results with total revenue of $13.7 million, up 61% quarter-over-quarter, driven by FINTEPLA® sales of $12.3 million (up 53%). Over 700 patients were referred to the FINTEPLA REMS program, with 560 patients receiving therapy. The company launched FINTEPLA in Germany and initiated the Zogenix Access Program to broaden global access. Future submissions for FINTEPLA in Lennox-Gastaut syndrome are planned in Q3 and Q4 2021, while an NDA for MT1621 in TK2 deficiency is expected in H1 2022.
Zogenix has launched a global access program for FINTEPLA (fenfluramine), approved as an add-on therapy for seizures related to Dravet syndrome in patients aged two years and older. This program facilitates access in regions where FINTEPLA is not commercially available, including some European countries without reimbursement. Clinical studies have shown FINTEPLA significantly reduces seizures for many patients. Zogenix collaborates with Durbin to manage this initiative, aimed at meeting the needs of physicians and patients globally.
Zogenix (NASDAQ: ZGNX) released new data on April 22, 2021, indicating that treatment with FINTEPLA (fenfluramine) shows significant improvements in everyday executive function for children and young adults with Lennox-Gastaut syndrome (LGS). The study revealed that FINTEPLA-treated patients demonstrated statistically significant enhancement in cognition (27% vs. 13% placebo, p=0.046) and overall executive function (25% vs. 11% placebo, p=0.034). These findings underline FINTEPLA's potential as a treatment option for managing the severe challenges associated with LGS.
Zogenix, a biopharmaceutical company focused on rare disease therapies, will announce its Q1 2021 financial results on May 6, 2021, at 4:30 PM ET. The company is known for its FDA-approved therapy, FINTEPLA, for Dravet syndrome and has additional late-stage programs in rare epilepsies and mitochondrial disorders. The call will also include updates on ongoing developments and potential future studies.
Zogenix (NASDAQ: ZGNX) announced findings from an investigator-initiated study on the benefits of FINTEPLA (fenfluramine) for Dravet syndrome patients and their caregivers. Seizure-related benefits included fewer seizures, reduced triggers, and shorter recovery times. Non-seizure benefits noted by caregivers involved significant improvements in cognition, mood, and sleep quality, leading to reduced stress and anxiety. The study involved 59 caregivers and highlighted a positive impact on family dynamics and overall quality of life, reinforcing previous Phase 3 study outcomes.
Zogenix, a biopharmaceutical company focused on rare diseases, will participate in the 20th Annual Needham Virtual Healthcare Conference on April 12, 2021. Stephen J. Farr, Ph.D., CEO, and Michael Smith, CFO, are scheduled for a fireside chat at 11:00 AM ET. The event will be available via a live webcast and will be archived for 90 days on the Zogenix Investor Relations website. Zogenix is known for the FDA-approved therapy FINTEPLA® for Dravet syndrome and is also developing treatments for Lennox-Gastaut syndrome and TK2 deficiency.
Zogenix (NASDAQ: ZGNX) announced that Stephen J. Farr, Ph.D., President and CEO, and Michael Smith, Executive Vice President and CFO, will participate in a fireside chat at the Stifel 3rd Annual CNS Day on March 31, 2021, at 2:30 PM ET. The event will be available for live streaming and will be archived for 90 days on Zogenix's Investor Relations website. The company focuses on developing therapies for rare diseases, including FINTEPLA, approved for Dravet syndrome, and two other late-stage programs targeting Lennox-Gastaut syndrome and TK2 deficiency.
Zogenix, a biopharmaceutical company focused on rare disease therapies, announced that Michael Smith, CFO, will present a corporate overview at the Raymond James Institutional Investors Conference on March 3, 2021, at 3:50 PM Eastern Time. The presentation will be available via live webcast and archived for 90 days on the company's Investor Relations website. Zogenix is known for its FDA-approved therapy FINTEPLA for Dravet syndrome and is advancing additional therapies for rare genetic disorders.
Zogenix reported strong momentum for its FINTEPLA launch for Dravet syndrome, achieving $8.1 million in product sales in Q4 2020 and $9.6 million since the launch in July 2020. As of December 31, 2020, 550 patients had been referred to the FINTEPLA REMS program. The European Commission approved FINTEPLA in December 2020, with a launch in Germany planned for February 2021. The company ended the year with $505.1 million in cash and equivalents. However, a net loss of $70.2 million was reported for Q4 2020, consistent with previous year losses.
Zogenix, a biopharmaceutical company, announced that Stephen J. Farr, Ph.D., will participate in a fireside chat on February 26, 2021, at 1:00 PM Eastern Time during the 10th Annual SVB Leerink Global Healthcare Conference. The event will be available via live webcast and archived on the company's Investor Relations site for 90 days. Zogenix focuses on developing therapies for rare diseases, including FINTEPLA, approved for Dravet syndrome, and other programs targeting rare genetic disorders.
