Key Developments: Zogenix Inc (ZGNX.W)
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18 Jun 2013
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$1.48
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Latest Key Developments (Source: Significant Developments)
Zogenix Inc Reports Positive Top-Line Results From Extended Relday Phase 1 Clinical Trial
Zogenix Inc announced positive top-line results from its extended Phase 1 clinical trial of Relday, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. If approved, Relday has the potential to be the first subcutaneous antipsychotic product that allows for once-monthly dosing. Efforts are underway to secure a strategic development and commercialization partner for Relday. Full Article
Zogenix Inc and Battelle Extend DosePro Co-Marketing Partnership
Zogenix Inc and Battelle, the world's largest independent research and development organization, today announced they have extended their co-marketing partnership for the DosePro needle-free drug delivery system through March 29, 2014. The partnership is focused on advancing out-licensing opportunities for DosePro, with a focus on co-marketing the technology to potential biopharmaceutical and government clients. Full Article
DURECT Corp Licensee Zogenix Inc Announces Positive Results from Relday Phase 1 Clinical Trial
DURECT Corp announced that its licensee, Zogenix Inc, reported positive single-dose pharmacokinetic (PK) results from the Phase 1 clinical trial of Relday, an investigational candidate of a , once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 30 patients with chronic, stable schizophrenia or schizoaffective disorder. Per Zogenix, based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable evaluation of dose proportionality across the full dose range that would be anticipated to be used in clinical practice. Zogenix expects to complete the extension of the Phase 1 clinical trial during the second quarter of 2013. Full Article
Zogenix Inc Sees FY 2012 Revenue Guidance At Low End Of Prior Range
Zogenix Inc announced that for fiscal 2012, it expects total revenue to be approximately $45.5 million, at the low end of the previous guidance range. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $47 million for fiscal 2012. Full Article
Zogenix, Inc. Reaffirms FY 2012 Revenue Guidance
Zogenix, Inc. reaffirmed its fiscal 2012 revenue guidance of $45.5-$48.5 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $47.6 million for fiscal 2012. Full Article
Zogenix, Inc. Prices Public Offering of Common Stock and Warrants to Purchase Common Stock
Zogenix, Inc. announced that it has priced an underwritten public offering of 32,500,000 units. Each unit consists of one share of common stock and a warrant to purchase 0.45 of a share of common stock, at a price to the public of $2.00 per unit. Net proceeds, after underwriting discounts and commissions and estimated offering costs, will be approximately $60.7 million. Zogenix intends to use the net proceeds from the offering to repay all amounts outstanding under its amended and restated loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, to fund the pre-approval and pre-commercialization activities of Zohydro ER, for the ongoing commercialization of Sumavel DosePro and for working capital and other general corporate purposes. Zogenix has granted the underwriters a 30-day option to purchase up to 4,875,000 additional units to cover over-allotments, if any. The offering is expected to close on or about July 27, 2012, subject to satisfaction of customary closing conditions. Each warrant will have an exercise price of $2.50 per share, will be exercisable one year after the date of issuance and will expire five years from the date of issuance. Stifel Nicolaus Weisel and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. Leerink Swann LLC is acting as lead co-manager for the offering. Oppenheimer & Co. Inc. and William Blair & Company, L.L.C. are acting as co-managers for the offering. Full Article
Zogenix, Inc. Announces Proposed Public Offering Of Common Stock And Warrants To Purchase Common Stock
Zogenix, Inc. announced that it intends to offer units in an underwritten public offering, with each unit consisting of one share of Zogenix's common stock and a warrant to purchase a certain number of shares of Zogenix's common stock. All of the units are being offered by Zogenix. Zogenix intends to use the net proceeds from the offering to repay all amounts outstanding under its amended and restated loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, to fund the pre-approval and pre-commercialization activities of Zohydro ER, for the ongoing commercialization of Sumavel DosePro and for working capital and other general corporate purposes. Stifel Nicolaus Weisel and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
Zogenix, Inc. Announces U.S. Food And Drug Administration Acceptance For Review Of Zohydro ER New Drug Application For Treatment Of Chronic Pain
Zogenix, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Zohydro ER (hydrocodone bitartrate extended-release capsules), Zogenix's lead investigational product candidate for the treatment of moderate to severe chronic pain. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an NDA is 10 months from NDA submission, and the FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA. The NDA submission is based on data from more than 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801) and an open-label Phase 3 safety study (Study 802) of Zohydro ER. Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro ER resulted in significantly (p=0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints in this study (the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication) were also met. Additional study endpoints were supportive of the efficacy of Zohydro ER compared to placebo. The commonly reported adverse events (≥2%) in placebo-controlled pivotal Phase 3 efficacy Study 801 in opioid-experienced patients were consistent with those typically seen with chronic opioid therapy and were constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting and pruritus. Full Article
Mallinckrodt LLC, The Pharmaceuticals Business Of Covidien PLC, And Zogenix Inc. Announce Exclusive Co-Promotion Arrangement On SUMAVEL DosePro
Mallinckrodt LLC, the Pharmaceuticals business of Covidien plc announced that it has entered into a co-promotion agreement with Zogenix Inc., for SUMAVEL DosePro (sumatriptan injection), a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches. Under terms of the agreement, Mallinckrodt’s U.S. sales force will sell SUMAVEL DosePro to its customer base of prescribers. Zogenix will continue to record all product revenues and Mallinckrodt will be compensated based on a percentage of net sales from prescriptions generated by Mallinckrodt. The agreement runs through June 30, 2014, and can be extended. Full Article
Zogenix, Inc. Reaffirmed FY 2012 Revenue Guidance
Zogenix, Inc. reaffirmed its fiscal 2012 revenue guidance of $45.5-$48.5 million. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $47.1 million for fiscal 2012. Full Article
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