| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | March 7, 2022 |
| Accession Number: | 0001193125-22-067479 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | March 7, 2022 |
| Accession Number: | 0001193125-22-067479 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
Save time and jump to the most important pieces.
| 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 |
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
15-12B - ZOGENIX, INC. (0001375151) (Filer)
EFFECT - ZOGENIX, INC. (0001375151) (Filer)
EFFECT - ZOGENIX, INC. (0001375151) (Filer)
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
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
4 - ZOGENIX, INC. (0001375151) (Issuer)
4 - ZOGENIX, INC. (0001375151) (Issuer)
4 - ZOGENIX, INC. (0001375151) (Issuer)
SC 13G/A - ZOGENIX, INC. (0001375151) (Subject)
SC 13G/A - ZOGENIX, INC. (0001375151) (Subject)
SC 13G/A - ZOGENIX, INC. (0001375151) (Subject)
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
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 $22.6 million in the third quarter, representing quarter-over-quarter increases of 22% and 20%, respectivelySubmitted supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for FINTEPLA in Lennox-Gastaut Syndrome (LGS)Continuing to advance late-stage development programs for FINTEPLA and MT1621 EMERYVILLE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2021, and provided a corporate update. The Company will host a conferen
BRUSSELS, Belgium and ATLANTA, March 7, 2022 /PRNewswire/ -- UCB (Euronext: UCB) today announced the successful completion of the previously announced transaction to acquire Zogenix (NASDAQ:ZGNX) for US$ 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