ZGNX
Zogenix, Inc.NASDAQ
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  • Mon, Nov. 7, 4:19 PM
    • Zogenix (NASDAQ:ZGNX): Q3 EPS of -$0.69 beats by $0.27.
    • Revenue of $6.6M (-27.6% Y/Y) beats by $3.5M.
    • Press Release
    | Mon, Nov. 7, 4:19 PM
  • Sun, Nov. 6, 5:35 PM
  • Fri, Oct. 7, 11:48 AM
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    • AmerisourceBergen (NYSE:ABC) initiated with Neutral rating by UBS.
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    • Zogenix (NASDAQ:ZGNX) initiated with Outperform rating and $17 (64% upside) price target by Leerink Swann.
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    | Fri, Oct. 7, 11:48 AM | 8 Comments
  • Tue, Aug. 9, 4:24 PM
    • Zogenix (NASDAQ:ZGNX): Q2 EPS of -$0.76 beats by $0.05.
    • Revenue of $2.1M (-71.5% Y/Y) misses by $3.26M.
    • Press Release
    | Tue, Aug. 9, 4:24 PM
  • Mon, Aug. 8, 5:35 PM
  • Mon, Jun. 27, 5:35 PM
    | Mon, Jun. 27, 5:35 PM | 3 Comments
  • Tue, May 10, 4:18 PM
    • Zogenix (NASDAQ:ZGNX): Q1 EPS of -$0.42 beats by $0.20.
    • Revenue of $9.2M (+99.6% Y/Y) beats by $4.3M.
    | Tue, May 10, 4:18 PM
  • Mon, May 9, 5:35 PM
  • Thu, May 5, 10:41 AM
    • New data from nine patients with Dravet syndrome treated with Zogenix's (ZGNX -3.6%) lead product candidate, Fast Track-tagged ZX008 (low-dose fenfluramine), show a significant reduction in the number of seizures per month. The results were presented at the 14th International Child Neurology Congress in Amsterdam.
    • All nine subjects began add-on treatment with ZX008 (5 mg to 20 mg daily) between 2010 and 2016. Median treatment duration was 1.5 years (range: 0.3 - 5.1 years). During the 90-day run-in period prior to initiating treatment with ZX008, the median frequency of major motor seizures ((MMSs)) was 15.0 per month (range: 0.4 - 39.7). Over the observation period, the median frequency of MMSs decreased to 1.5 per month, a reduction of 75% (range: 28 - 100%). Six of the nine patients experienced at least a 70% reduction in MMSs.
    • Mean Quality of Life score was 7.4 out of 10 (0=extremely bad, 10=very good) as measured by a survey of parents and caregivers which reinforced the dramatically improved quality of life, including improved sleep quality, from treatment with ZX008.
    • ZX008 was generally well-tolerated with no clinical or echocardiographic signs of cardiac valve abnormalities, pulmonary hypertension or any other cardiovascular issues. The most common treatment-emergent adverse events were mild-to-moderate drowsiness (n=6/9), diminished appetite (n=4/9); mood changes (n=2/9) and non-convulsive status epilepticus (n=2).
    • Phase 3 study in Dravet patients is currently recruiting patients. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, the change in mean convulsive seizure frequency, is November. The estimated study completion date is April 2017.
    • Dravet syndrome is a rare and catastrophic form of childhood epilepsy.
    • ZX008 is a low-dose formulation of fenfluramine, the "Fen" component of the anti-obesity medication Fen-phen that was withdrawn from the U.S. market in 1997 due to its association with heart valve disease.
    | Thu, May 5, 10:41 AM
  • Mon, Mar. 14, 8:17 AM
    • Small cap GW Pharmaceuticals (NASDAQ:GWPH) is up a whopping 127% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial assessing Orphan Drug- and Fast Track-tagged Epidiolex (cannabidiol) for the treatment of Dravet syndrome, a rare and catastrophic form of childhood epilepsy for which there are no approved treatments. The study met its primary endpoint of a statistically valid reduction in convulsive seizures over the 14-week treatment period compared to placebo.
    • The 120-subject study compared 20 mg/kg/day of Epidiolex (n=61) to placebo (n=59). On average, patients were receiving 3 anti-epileptic drugs (AEDs), having tried and failed an average of four other AEDs. Median baseline convulsive seizure frequency was 13/month. Patients receiving Epidiolex experienced a 39% reduction in monthly convulsive seizures versus 13% for placebo (p=0.01). The superiority of Epidiolex was observed in the first month of treatment and was sustained throughout the 14 weeks.
    • Epidiolex was generally well-tolerated in the trial. The most common adverse events (>10%) were somnolence (drowsiness), diarrhea, decreased appetite, fatigue, pyrexia (elevated body temperature), vomiting, lethargy, upper respiratory tract infection and convulsion. 84% of the AEs were mild or moderate. Ten patients Epidiolex patients experienced a serious adverse event compared to three for placebo. Eight Epidiolex patients discontinued treatment due to AEs versus one for placebo. The data will be presented at future medical meetings and will be submitted for publication.
    • The company plans to hold a pre-NDA meeting with the FDA as soon as feasible to discuss its regulatory submission, expected by mid-year.
    • A second pivotal study in Dravet in ongoing as well as two Phase 3s in Lennox-Gastaut syndrome, another form of severe childhood epilepsy.
    • Dravet-related tickers: (NASDAQ:ZGNX)(NASDAQ:INSY)
    | Mon, Mar. 14, 8:17 AM | 8 Comments
  • Fri, Mar. 11, 7:17 AM
    • Zogenix (ZGNX) Q4 results: Revenues: $6.1M (-38.4%); R&D Expense: $8.6M (+160.6%); SG&A: $6.8M (+17.2%); Operating Loss: ($14.1M) (-83.1%); Net Loss: ($11.9M) (-24.0%); Loss Per Share: ($0.36) (+67.0%).
    • FY2015 results: Revenues: $27.2M (-5.9%); R&D Expense: $27.9M (+134.5%); SG&A: $26.3M (-24.0%); Operating Loss: ($47.7M) (-215.2%); Net Loss: ($41.7M) (-167.8%); Quick Assets: $155.3M (+268.0%).
    • 2016 Guidance: R&D Expenses: $54M - 59M; SG&A Expenses: $25M - 27M.
    | Fri, Mar. 11, 7:17 AM
  • Thu, Mar. 10, 4:12 PM
    • Zogenix (NASDAQ:ZGNX): Q4 EPS of -$0.36 beats by $0.33.
    • Revenue of $6.1M (-38.4% Y/Y) misses by $0.29M.
    | Thu, Mar. 10, 4:12 PM
  • Wed, Mar. 9, 5:35 PM
  • Tue, Jan. 19, 8:58 AM
    | Tue, Jan. 19, 8:58 AM
  • Dec. 14, 2015, 4:30 PM
    • The FDA clears Zogenix's (NASDAQ:ZGNX) Investigational New Drug (IND) application for lead product candidate ZX008. The approval allows the company to initiate its Phase 3 program for the adjunctive treatment of seizures in children with Dravet syndrome, a rare and catastrophic form of intractable epilepsy that begins in infancy.
    • The company intends to conduct two randomized, double-blind, placebo-controlled studies that will assess two doses of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum dose of 30 mg/day) versus placebo. Each will enroll 105 subjects with 35 patients in each arm. One will be conducted primarily in the U.S. and Canada and the other in Europe.
    • The primary endpoint will be the change in frequency of convulsive seizures compared to placebo. Secondary endpoints include 40% and 50% responder analyses and convulsive seizure-free interval.
    • The company intends to initiate the U.S.-based study this month. Top-line results should be available in 2016.
    • ZX008 is a low-dose fenfluramine. It was the "Fen" component of the anti-obesity medication Fen-phen that was withdrawn from the U.S. market in 1997 due to its association with heart valve disease.
    | Dec. 14, 2015, 4:30 PM | 1 Comment
  • Nov. 9, 2015, 4:10 PM
    • Zogenix (NASDAQ:ZGNX): Q3 EPS of -$0.65 beats by $0.09.
    • Revenue of $9.1M (+85.7% Y/Y) beats by $3.2M.
    | Nov. 9, 2015, 4:10 PM