Zogenix, Inc., a biopharmaceutical company, develops and commercializes therapies to transform the lives of patients and their families living with rare diseases in the United States. The company's lead product candidate is the Fintepla, a low-dose fenfluramine, which is in Phase III clinical trials for the treatment of seizures associated with Dravet syndrome, as well as to treat seizures associated with Lennox-Gastaut syndrome; and that is in Phase II clinical trials for the treatment of other rare epileptic syndromes and diseases. It is also developing MT1621, an investigational therapy for the treatment of a rare genetic disorder called thymidine kinase 2 deficiency. Zogenix, Inc. has a collaboration with Tevard Biosciences for the research, development and commercialization of novel gene therapies for Dravet Syndrome and other genetic epilepsies. The company was formerly known as SJ2 Therapeutics, Inc. and changed its name to Zogenix, Inc. in August 2006. Zogenix, Inc. was incorporated in 2006 and is headquartered in Emeryville, California.
IPO Year: 2010
Exchange: NASDAQ
Website: zogenix.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 2/28/2022 | Outperform → Market Perform | Northland Capital | |
| 1/19/2022 | Buy → Hold | Needham | |
| 12/20/2021 | $37.00 → $32.00 | Outperform | SVB Leerink |
| 9/9/2021 | $23.00 | Buy | UBS |
| 8/6/2021 | $48.00 → $44.00 | Buy | Needham |
| 8/6/2021 | $42.00 → $37.00 | Outperform | SVB Leerink |
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Northland Capital downgraded Zogenix from Outperform to Market Perform
Needham downgraded Zogenix from Buy to Hold
SVB Leerink reiterated coverage of Zogenix with a rating of Outperform and set a new price target of $32.00 from $37.00 previously
UBS initiated coverage of Zogenix with a rating of Buy and set a new price target of $23.00
Needham reiterated coverage of Zogenix with a rating of Buy and set a new price target of $44.00 from $48.00 previously
SVB Leerink reiterated coverage of Zogenix with a rating of Outperform and set a new price target of $37.00 from $42.00 previously
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-9) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 05/30/2023. Application Category: NDA, Application Number: 212102, Application Classification: REMS
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-6) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 01/03/2023. Application Category: NDA, Application Number: 212102, Application Classification: Labeling
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-5) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 06/15/2022. Application Category: NDA, Application Number: 212102, Application Classification: Labeling
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-3) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 03/25/2022. Application Category: NDA, Application Number: 212102, Application Classification: Efficacy
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-3) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 03/28/2022. Application Category: NDA, Application Number: 212102, Application Classification: Efficacy
Submission status for ZOGENIX INC's drug FINTEPLA (SUPPL-1) with active ingredient FENFLURAMINE HYDROCHLORIDE has changed to 'Approval' on 03/28/2022. Application Category: NDA, Application Number: 212102, Application Classification: Labeling
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BRUSSELS, Belgium and ATLANTA, March 7, 2022 /PRNewswire/ -- UCB (Euronext: UCB) today announced the successful completion of the previously announced transaction to acquire Zogenix (NASDAQ:ZGNX) for US$ 26.00 per share plus a milestone-based contingent value right for a potential cash payment of US$ 2.00 per share. The total transaction is valued at up to approximately US $1.9 billion / €1.7 billion*. Charl van Zyl, Executive Vice President, Neurology & Head of Europe/International Markets, UCB, said: "We are very pleased to reach today's milestone at the earliest opportunity
Two podium and one poster presentation share important new findings on FINTEPLA's safety profile and its impact on non-seizure related benefits for LGS patientsLGS is a debilitating childhood-onset developmental and epileptic encephalopathy estimated to affect approximately 30,000-50,000 patients in the U.S.1 EMERYVILLE, Calif., March 04, 2022 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, announced that new data from the company's research and development program for FINTEPLA® (fenfluramine) in Lennox Gastaut syndrome (LGS) will be presented at the hybrid American Academy of Neurology (AAN) Annual Mee
Executive with decades of leadership in biopharma and entrepreneurship to aid global commercialization efforts for Company's Immunopheresis® therapy Immunicom, Inc., a clinical-stage biotechnology company pioneering subtractive therapies for cancer and other autoimmune diseases, today announced Jennifer "J.D." Haldeman has joined the company as Vice President of Commercial Operations. Haldeman brings many decades of executive leadership experience to Immunicom. She has led commercial teams for both private and public companies in the biopharma, diagnostics, and medical device arenas, where she was responsible for launching more than a dozen innovative products. Jennifer spent the first te
Total revenue of $26.6 million in the fourth quarter and $81.7 million for the full yearFINTEPLA® net product sales of $23.5 million in the fourth quarter and $74.7 million for the full year Announced U.S. Food and Drug Administration acceptance with Priority Review of Supplemental New Drug Application for FINTEPLA in Lennox-Gastaut Syndrome (LGS)Submitted Type II Variation Application to the European Medicines Agency to expand the use of FINTEPLA for LGSSubmitted New Drug Application to Japan's Ministry of Health, Labour & Welfare for the marketing approval of FINTEPLA in Dravet syndromePreviously announced agreement to be acquired by UCB; transaction expected to close in the first half of
Symptoms of mitochondrial diseases, such as Thymidine Kinase 2 deficiency (TK2d), can vary widely and mimic other rare and common diseases, making diagnosis challenging 1,2,3Genetic testing offers a quicker, confirmatory path to diagnosis, enabling more accurate care and participation in available clinical trials 1,2,3An estimated 1 in 5,000 individuals has a genetic mitochondrial disease 4 EMERYVILLE, Calif., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced that the company is sponsoring a new no-cost genetic testing program, the United Mitochondrial Disease Foundation (UMDF) Pilot Genetic Testi
BRUSSELS and EMERYVILLE, Calif., Jan. 19, 2022 /PRNewswire/ -- Regulated information – Inside information – UCB (Euronext: UCB) and Zogenix (NASDAQ:ZGNX) announced today that the companies have entered into a definitive agreement under which UCB would acquire Zogenix, Inc., a global biopharmaceutical company commercializing and developing therapies for rare diseases. Under the terms of the agreement, UCB will commence a tender offer to purchase all outstanding shares of Zogenix for a purchase price per share of US$ 26.00 in cash at closing, plus a contingent value right (CVR) for a potential cash payment of US$ 2.00 upon EU approval by December 31, 2023, of FINTEPLA® as an orphan medicine fo
EMERYVILLE, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Zogenix, a global biopharmaceutical company specializing in rare disease therapies, announced that it has submitted a New Drug Application (J-NDA) to the Japanese Ministry of Health, Labour & Welfare (MHLW) for the marketing approval of FINTEPLA® (fenfluramine) for the treatment of epileptic seizures associated with Dravet syndrome in Japan. FINTEPLA received Orphan Drug Designation from Japan's Ministry of Health, Labour & Welfare (MHLW) in August 2021. "There remains a substantial unmet need in the Dravet syndrome treatment landscape globally, and Japan is no exception where patients continue to experience refractory seizures that ne
EMERYVILLE, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it has submitted its Type II Variation Market Authorization Application to the European Medicines Agency (EMA) for FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a highly treatment-resistant form of childhood-onset epilepsy. If approved, the application would expand the use of FINTEPLA in Europe beyond Dravet syndrome to include LGS. "The submission of this Type II Variation is a significant milestone for our FINTEPLA program and furthers our goal of bringing FINTE
EMERYVILLE, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX) today announced that the compensation committee of the company's board of directors granted inducement awards to nine (9) new non-executive employees. The awards were made on December 15, 2021, under Zogenix's 2021 Employment Inducement Equity Incentive Award Plan, which was approved by the company's board of directors under Nasdaq Marketplace Rule 5635(c)(4), for granting equity awards to new employees of Zogenix as an inducement to join the company. The awards consist of options to purchase an aggregate of 84,400 shares of Zogenix common stock and 17,300 restricted stock units. The options have a ten year term an
EMERYVILLE, Calif., Dec. 02, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it will present new FINTEPLA® (fenfluramine) data from eight abstracts at the American Epilepsy Society (AES) Annual Meeting, taking place from December 3-7, 2021, in Chicago, IL. The Company will also have an additional four posters in a virtual scientific exhibition room and is sponsoring the Better Outcomes Through Diversity poster session during AES 2021. "We continue to see positive safety and efficacy data of FINTEPLA for individuals with Dravet syndrome and Lenox-Gastaut syndrome," said Bradley
Live Leadership Updates
Executive with decades of leadership in biopharma and entrepreneurship to aid global commercialization efforts for Company's Immunopheresis® therapy Immunicom, Inc., a clinical-stage biotechnology company pioneering subtractive therapies for cancer and other autoimmune diseases, today announced Jennifer "J.D." Haldeman has joined the company as Vice President of Commercial Operations. Haldeman brings many decades of executive leadership experience to Immunicom. She has led commercial teams for both private and public companies in the biopharma, diagnostics, and medical device arenas, where she was responsible for launching more than a dozen innovative products. Jennifer spent the first te
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Total revenue of $26.6 million in the fourth quarter and $81.7 million for the full yearFINTEPLA® net product sales of $23.5 million in the fourth quarter and $74.7 million for the full year Announced U.S. Food and Drug Administration acceptance with Priority Review of Supplemental New Drug Application for FINTEPLA in Lennox-Gastaut Syndrome (LGS)Submitted Type II Variation Application to the European Medicines Agency to expand the use of FINTEPLA for LGSSubmitted New Drug Application to Japan's Ministry of Health, Labour & Welfare for the marketing approval of FINTEPLA in Dravet syndromePreviously announced agreement to be acquired by UCB; transaction expected to close in the first half of
BRUSSELS and EMERYVILLE, Calif., Jan. 19, 2022 /PRNewswire/ -- Regulated information – Inside information – UCB (Euronext: UCB) and Zogenix (NASDAQ:ZGNX) announced today that the companies have entered into a definitive agreement under which UCB would acquire Zogenix, Inc., a global biopharmaceutical company commercializing and developing therapies for rare diseases. Under the terms of the agreement, UCB will commence a tender offer to purchase all outstanding shares of Zogenix for a purchase price per share of US$ 26.00 in cash at closing, plus a contingent value right (CVR) for a potential cash payment of US$ 2.00 upon EU approval by December 31, 2023, of FINTEPLA® as an orphan medicine fo
FINTEPLA® net product sales of $21.4 million and total revenue of $22.6 million in the third quarter, representing quarter-over-quarter increases of 22% and 20%, respectivelySubmitted supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for FINTEPLA in Lennox-Gastaut Syndrome (LGS)Continuing to advance late-stage development programs for FINTEPLA and MT1621 EMERYVILLE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2021, and provided a corporate update. The Company will host a conferen
EMERYVILLE, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced data that it will report its financial results for the third quarter ended September 30, 2021 and host a corporate update conference call and webcast after the market close on Thursday, November 4, 2021, at 4:30 PM Eastern Time. Conference Call Details Thursday, November 4, at 4:30 PM Eastern Time / 1:30 PM Pacific TimeToll Free:855-327-6838International:604-235-2082Conference ID:10016695Webcast:http://public.viavid.com/index.php?id=146849 About Zogenix Zogenix is a global biopharmaceutical company committed to developing and co
Commercial launches of FINTEPLA® in the U.S. and Europe progressing strongly, with total net product sales of $17.5 million and total revenue of $18.8 million in the second quarter, representing quarter-over-quarter increases of 42% and 37%, respectivelyAs of June 30, 2021, over 860 patients have been prescribed FINTEPLA and referred to the REMS program, and there were 290 unique prescribers, an increase of 22% quarter-over-quarter On track to submit supplemental New Drug Application (NDA) seeking to expand FINTEPLA's label for treatment of Lennox-Gastaut syndrome (LGS) in Q3 2021, following positive meeting with U.S. Food and Drug Administration (FDA)Anticipate NDA submission for MT1621 in
EMERYVILLE, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that it will report its financial results for the second quarter ended June 30, 2021 and host a corporate update conference call and webcast after the market close on Thursday, August 5, 2021, at 4:30 PM Eastern Time. Conference Call DetailsThursday, August 5, at 4:30 PM Eastern Time / 1:30 PM Pacific TimeToll Free: 800-347-6311International: 323-994-2131Conference ID: 6229003Webcast: http://public.viavid.com/index.php?id=145894 About ZogenixZogenix is a glob
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