Market Oversells Zogenix After Company Exits Pain Business
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Zogenix: A Strong Turnaround For 2015
Maurelius • 13 Comments
Maurelius • 13 Comments
Mon, Jun. 27, 5:35 PM
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)
Oct. 19, 2015, 5:39 PM
Oct. 19, 2015, 4:26 PM
- Zogenix (NASDAQ:ZGNX) reports that the FDA has requested additional information pertaining to its proposed Phase 3 program for ZX008 for Dravet syndrome, specifically information related to normative ranges for echocardiograms performed during the trial and an amended study protocol to include a required follow-up echocardiogram three to six months after patients discontinue treatment with ZX008. The company has responded to the agency's request and expects to initiate the Phase 3 study this quarter.
- Shares are down 14% after hours on light volume.
Jul. 15, 2015, 12:45 PM
May 27, 2015, 9:18 AM
May 21, 2015, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Mar. 11, 2015, 12:47 PM
Mar. 11, 2015, 10:06 AM
- Investors take a dim view of Zogenix's (ZGNX -22.8%) divestment of Zohydro ER for potentially up to $384M. Shares plummet on more than a 2x surge in volume.
- Previously: Zogenix sells Zohydro business to Pernix Therapeutics for up to $384M (March 10)
Mar. 11, 2015, 9:11 AM
Feb. 2, 2015, 1:22 PM
- Turnover in Zogenix (ZGNX +4.4%) is already up four-fold today in response to the regulatory approval of an abuse-deterrent formulation of Zohydro but shares have not been able to hold on to the intraday high of $1.52.
- On a technical basis, a breakout above $1.48 on high volume would be reassuring to bulls.
- Previously: FDA clears abuse-deterrent formulation of Zohydro (Jan. 31)
Feb. 2, 2015, 9:12 AM
Jan. 23, 2015, 11:38 AM
- Thinly-traded nano cap Egalet (EGLT +32.7%) has jumped almost 60% since yesterday in response to its announcement of positive results from a Category 3 human abuse liability (HAL) study of Egalet-001 (abuse deterrent extended release oral morphine). The study showed that the abuse potential of Egalet-101 taken orally was significantly lower than that for manipulated MS Contin (morphine sulfate controlled-release).
- Egalet-001's abuse deterrent characteristics are based on the company's Guardian technology which makes the pill extremely hard, difficult to chew and resists common methods of physical and chemical manipulation. For example, it turns to gel when exposed to water.
- The company will disclose the results from additional abuse-deterrent studies later this year.
- Related tickers: (ZGNX +2.3%)(ACUR -1.6%)(ALKS +0.4%)
Dec. 30, 2014, 3:49 PM
- Micro cap Zogenix (ZGNX +8.1%) gives long-suffering longs a bit of hope today on a 2.5x surge in volume. Shares plummeted 79% from the February 13 high of $5.19 to the December 16 low of $1.08.
- Yesterday, Brean Capital initiated coverage with a Buy rating and $2.50 price target.
- The PDUFA date for its sNDA for an abuse deterrent formulation of Zohydro ER (hydrocodone bitartrate) is January 30.
- Previously: Zogenix submits sNDA for abuse deterrent Zohydro (Oct. 1)
Sep. 18, 2014, 9:06 AM
Aug. 5, 2014, 4:14 PM
- Zogenix (NASDAQ:ZGNX): Q2 EPS of -$0.19 misses by $0.02.
- Revenue of $9.2M (+2.9% Y/Y) beats by $0.28M.
- Shares +1.5%.
Zogenix, Inc. is a pharmaceutical company, which is engaged in commercializing and developing products for the treatment of central nervous system disorders and pain with novel drug delivery platforms. The company's product portfolio includes: Sumavel DosePro, Zohydro and Relday. The Sumavel... More
Industry: Drug Manufacturers - Major
Country: United States