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 |
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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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
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
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
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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Here's a roundup of top developments in the biotech space over the last 24 hours. Stocks In Focus MEI Pharma Says FDA Recommends Additional Phase 3 Study For Facilitating Regulatory Filing For Zandelisib As Blood Cancer Treatment Option MEI Pharma, Inc. (NASDAQ:MEIP) and Japanese pharma company Kyowa Kirin said the FDA had r required a randomized trial to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. The companies were hoping to get marketing authorization for zandelisib via the accelerated approval pathway under 21 CFR Part 314.500, Subpart H, based on data generated by the single arm Phase 2 TIDAL study. Zandelisib is being develope
Today's 5 Stock Ideas: Boeing (BA) - Shares were down 6% Monday morning following the crash of a China Eastern Airlines (CEA) Boeing 737 aircraft in China. Shares of China Eastern Air were also lower, down about 12%. Coinbase (COIN) - A new short by notable short seller and manager of hedge fund Kynikos, Jim Chanos. BitNile (NILE) - A penny stock play on a bitcoin mining company. Shares were up about 80% on Monday; the stock flirted with the $1 level. The Benzinga newsdesk did not see news to justify the move higher. While the company did announce its TurnOnGreen subsidiary would be acquired, the stock was moving prior to the M&A news. Zogenix (ZGNX) - An FDA pla
Biotech stocks rebounded along with the broader market in the week ending March 18, as risk appetite returned. Multiple conference presentations, clinical readouts and earnings news dictated sentiment during the week. Synthetic Biologics, Inc. (NYSE:SYN) was among the biggest advancers, as the stock reacted to its quarterly results. On the other hand, Nektar Therapeutics (NASDAQ:NKTR) came under pressure following negative results from a late-study of its investigational cancer drug in combination of Bristol-Myers Squibb Company's (NYSE:BMY) Opdivo. Bristol-Myers Squib, meanwhile, received the Food and Drug Administration's approval for its Lag-3 antibody relatilimab, in combination with
Merger activity increased last week with six new deals announced and six deals completed. Three of the six new deals announced were potential deals in the works. Healthcare Trust of America (NYSE:HTA) Founded in 2006, Healthcare Trust of America is a healthcare focused REIT and the largest operator of dedicated medical office buildings (MOB) in the United States. The company owns real estate though 461 on-campus and off-campus properties around hospitals and Universities in 32 states. We added HTA to our ‘Deals in the Works‘ tool on October 6, 2021, when Bloomberg reported that activist investor Elliott Investment Management was pushing for the company to launch a strategic review that inc
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 Meeting 2022, in-person in Seattle (April 2-7) and held virtually (April 24-26). "At AAN, we look forward to sharing our latest research for FINTEPLA in LGS that highlights long-term evidence of its cardiovascular safety profile as well as sustained reduction in drop seizure frequency," said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer, Zoge
The Food and Drug Administration approval calendar was light in February. Nevertheless, the month saw regulatory nods accorded to some breakthrough therapies. Agios Pharmaceuticals, Inc.'s (NASDAQ:AGIO) Pyrukynd (mitapivat) was approved for the treatment of hemolytic anemia in people with pyruvate kinase deficiency. Hemolysis refers to the destruction of red blood cells. Pyrukynd is a "new molecular entity," a term that refers to a drug containing an active moiety that hasn't been previously approved by the FDA. NME approval, therefore, is considered a measure of innovation in drug research. Another NME that passed the FDA hurdle was Sanofi's (NASDAQ:SNY) Enjaymo for the treatment of he
Zogenix (NASDAQ:ZGNX) reported its Q4 earnings results on Monday, February 28, 2022 at 08:00 AM. Here's what investors need to know about the announcement. Earnings Zogenix missed estimated earnings by 11.36%, reporting an EPS of $-0.98 versus an estimate of $-0.88. Revenue was up $18.11 million from the same period last year. Past Earnings Performance Last quarter the company missed on EPS by $0.07 which was followed by a 0.95% increase in the share price the next day. Here's a look at Zogenix's past performance: Quarter Q3 2021 Q2 2021 Q1 2021 Q4 2020 EPS Estimate -0.97 -0.94 -1.02 -1 EPS Actual -1.04 -1.05 -1
Zogenix (NASDAQ:ZGNX) reported quarterly losses of $(0.98) per share. This is a 22.22 percent increase over losses of $(1.26) per share from the same period last year. The company reported $26.60 million in sales this quarter. This is a 212.87 percent increase over sales of $8.50 million the same period last year.
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 Testing Project, in partnership with UMDF and Probably Genetic, to help patients obtain a confirmed genetic diagnosis of mitochondrial disease. The program is available to any eligible patient in the U.S. with a suspected diagnosis of mitochondrial disease. Mitochondrial diseases are a group of rare, debilitating conditions that can severely impact daily living and quality of life, and are often fatal.5,6 "Because mitochondrial diseases affect vario
Biotech stocks pulled back yet again during the week ending Jan. 21, with the sector retreating along with the broader market. The news flow tapered off following the frenetic pace of the week that encompassed the JPM Healthcare conference. On the M&A front, rare disease biopharma Zogenix, Inc. (NASDAQ:ZGNX) agreed to be acquired by Belgium's UCB SA (OTC:UCBJY) for about $1.8 billion. Here are the key catalytic events biotech investors can look forward to in the unfolding week: Conferences B. Riley Virtual Oncology Conference: Jan. 27-28 PDUFA Dates The Food and Drug Administration is scheduled to announce by Saturday, Jan. 29, its verdict on Azurity's new drug application for