Wed, May 27, 11:34 AM
- New data from a five-year follow up period in a group of 12 Dravet syndrome patients being treated with low-dose fenfluramine, 10 mg - 20 mg per day, show that during any given year at least 80% (n=10/12) of the patients experienced at least a 75% reduction in the frequency of seizures, while three patients were seizure-free for all five years and five were seizure-free for two to four years. The results were presented at the European Paediatric Neurology Society meeting in Vienna, Austria.
- Fenfluramine (ZX008) is being developed by Zogenix (ZGNX +3.6%) which secured the rights to the product candidate via its October 2014 acquisition of Brabant Pharma. It intends to initiate a Phase 3 study in Dravet later this year.
- Dravet syndrome is a rare and severe form of childhood epilepsy.
Wed, May 27, 9:18 AM
Thu, May 21, 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%)
Tue, May 12, 10:09 AM
- Zogenix (ZGNX -1.4%) Q1 results: Revenues: $4.6M (-37.8%); R&D Expense: $5.2M (+108.0%); SG&A: $6.3M (-49.6%); Operating Loss: ($9.8M) (+13.3%); Net Loss: ($10.2M) (-104.0%); Loss Per Share: ($0.15) (+25.0%); Quick Assets: $21.3M (-49.3%).
- Q2 2015 Guidance: R&D Expenses: $25M - 28M; G&A Expenses: $21M - 23M.
Mon, May 11, 4:19 PM
Mon, Apr. 27, 4:16 PM
Wed, Mar. 11, 12:47 PM
Wed, Mar. 11, 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)
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Wed, Mar. 11, 9:11 AM
Wed, Mar. 11, 7:55 AM
- Zogenix (ZGNX -2.3%) Q4 results: Revenues: $14.9M (+50.5%); COGS: $9.4M (+32.4%); R&D Expense: $6M (+76.5%); SG&A: $17.7M (+31.1%); Operating Loss: ($27.1M) (-86.9%); Net Loss: ($20.5M) (+42.4%); Loss Per Share: ($0.14) (+50.0%).
- FY2014 results: Revenues: $40.5M (+22.7%); COGS: $15.8M (-25.5%); R&D Expense: $18.9M (+47.7%); SG&A: $88.9M (+77.8%); Operating Loss: ($20M) (+62.4%); Net Income: $8.6M (+110.6%); EPS: $0.06 (+91.9%); Quick Assets: $42.2M (-41.4%).
- No guidance given.
Tue, Mar. 10, 4:20 PM
- Zogenix (NASDAQ:ZGNX) enters into an agreement to sell its Zohydro ER business to Pernix Therapeutics (NASDAQ:PTX) for an upfront fee of $100M plus regulatory and sales milestones of up to $283.5M. The transaction includes the Zogenix sales organization and other select employees.
- The deal enables Zogenix to focus its development efforts on its late-stage CNS pipeline including the Orphan Drug-designated ZX008 for the treatment of Dravet syndrome and Relday, a long-acting injectable formulation of risperidone for the maintenance treatment of schizophrenia.
- Zogenix will host a conference call this afternoon at 4:30 pm ET to discuss the deal.
Tue, Mar. 10, 4:07 PM
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Mon, Mar. 9, 5:35 PM
Wed, Feb. 25, 9:42 AM
- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(EGLT)(OTCQB:ELTP)(PFE -0.7%)(ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
ZGNX vs. ETF Alternatives
Zogenix Inc is a pharmaceutical company engaged in commercializing & developing therapies that address clinical needs for people living with pain-related and CNS disorders that needs treatment alternatives to help return to normal daily functioning.
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