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UCB Buys Rare Disease Drugmaker Zogenix For Up To $1.9B, Bolstering Its Epilepsy Position
by Angus Liu | Jan 19, 2022 11:16am
Click For Article
UCB hopes to leverage its existing expertise and global reach in epilepsy to accelerate the rollout of Zogenix's blockbuster hopeful Fintepla in rare types of epilepsy. (UCB)
UCB, maker of several epilepsy drugs, is expanding its portfolio in the field with an acquisition.
For up to $1.9 billion, UCB has agreed to buy Zogenix. In what UCB CEO Jean-Christophe Tellier described as a strong “strategic fit,” the deal gives the Belgian pharma Fintepla, a drug with blockbuster potential for treating rare types of epilepsy.
The deal comes as UCB’s own epilepsy drug Vimpat, currently one of the only two products in the company’s offerings with blockbuster sales, is expected to lose U.S. market exclusivity in March. As an FDA-approved therapy, Fintepla can immediately contribute to UCB’s top line once the deal closes, which is expected in the second quarter of 2022.
UCB hopes to leverage its existing expertise and global reach to accelerate the drug's rollout, Charl van Zyl, UCB’s executive vice president of neurology & head of Europe and international markets, said in a statement.
The Belgian pharma already markets four epilepsy treatments: Keppra, Vimpat, Briviact and Nayzilam. Together, those drugs have treated more than 3 million patients worldwide, UCB says. The four meds booked €1.4 billion sales in the first half of 2021, with over half from Vimpat.
Meanwhile, through a 2020 acquisition of Engage Therapeutics for $125 million upfront, UCB gained an inhaled version of alprazolam, which is now in phase 3 testing for acute treatment of epileptic seizure.
As for Fintepla, the drug was approved by the FDA in 2020 to treat seizures associated with Dravet syndrome, a rare type of epilepsy. Zogenix has an application under FDA priority review for seizures caused by Lennox-Gastaut syndrome (LGS), another rare and severe form of epilepsy that begins early in life. The U.S. biotech is also targeting the drug for a genetic epilepsy called CDKL5 deficiency disorder in a phase 3 trial. All told, Zogenix thinks Fintepla could reach $1 billion in peak sales.
Fenfluramine, the active ingredient in Fintepla, was previously offered as part of an anti-obesity regimen known as Fen-Phen. That therapy was later pulled off the market because of the side effects of pulmonary hypertension and heart valve disease. Thanks to that earlier safety signal, Fintepla is now managed through an FDA-designated monitoring program.
The cardiovascular disease problem only manifests when fenfluramine is given at a high dose that’s not used in Fintepla’s clinical programs, Iris Loew-Friedrich, UCB’s chief medical officer, said during a conference call Wednesday. Neither the drug’s clinical trials nor the postmarketing surveillance program has spotted any of the heart problems, she added.
Zogenix’s stock has been under pressure as COVID-19 slows the ramp of Fintepla. The rare disease drug brought in $21.4 million in sales in the third quarter, with 133 new patient starts during the quarter.
UCB is buying Zogenix shares for $26 apiece in cash, which represents a 72% premium to the company’s shares based on a 30-day average. The $1.9 billion deal also includes a $2-per-share payment in the form of a contingent value right that’s conditioned upon EU approval of Fintepla as an orphan medicine for LGS before the end of 2023.
Despite UCB’s existing presence in epilepsy, the company doesn’t expect any antitrust resistance from regulators, van Zyl told investors during Wednesday’s call. The rare epilepsy subtypes that Fintepla is targeting don’t overlap with any UCB drugs, he noted.
TTE
FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
EMERYVILLE, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved FINTEPLA® (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
This drug will be a direct competitor of GWPH's Epidiolex - which had $300 million in sales in its first year.
IG
On April 8, 2019, Zogenix, Inc. (the “Company”), announced that it received a Refusal to File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for FINTEPLA (ZX0008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. Upon its preliminary review, the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review. In the letter, the FDA cited two reasons for the RTF decision: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA. The FDA has not requested or recommended additional clinical efficacy or safety studies.
The Company will seek immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter in order to re-file the NDA.
The Company’s Marketing Authorization Application (“MAA”) for FINTEPLA for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency (“EMA”), and the Company anticipates an approvability decision could be reached by the EMA in the first quarter of 2020.
ZGNX 35.50 16.50 (-31.82%)
Works for me.
Blessings to All
TRUTH
Zogenix Shares Soar 19% Premarket After News Of Positive Trial For Severe Epilepsy Treatment -- MarketWatch
7:20 am ET July 12, 2018 (MarketWatch)
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Print
Zogenix Inc. shares (ZGNX) soared about 19% in premarket trade Thursday, after the biotech reported positive results in a late-stage trial of a treatment for the severe form of epilepsy, Dravet syndrome, in children and young adults. The company said the Phase 3 study of its investigational drug ZX008 met its primary endpoint of reducing convulsive seizure frequency, as well as secondary endpoints. "These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe," said Professor Rima Nabbout, M.D., Ph.D., Department of Pediatric Neurology, Reference Center for Rare Epilepsies, Necker Enfants Malades Hospital, and Principal Investigator of the trial, called Study 1504. If approved, the drug has the potential to be transformative, for a disease with few available treatment options, he added. Zogenix shares have gained 16.6% in 2018 through Wednesday, while the S&P 500 has gained 3.8%.
-Ciara Linnane
For more from MarketWatch: http://www.marketwatch.com/newsviewer
(END) Dow Jones Newswires
July 12, 2018 07:20 ET (11:20 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Doesn't look like the market is worried about it. At $40/share, 4.3 million shares is $172 million the company will raise. Dilutes each share by about 20% using the market cap. Could see a drop but I doubt it'll go to $20. It's expected for a development-stage biotech in Phase 3, with more trial results to come in June 2018.
niceee right back to 40++
LOL LOL You have to admit though....
Buyout/Merger news at EOD would be the last thing some people gonna want to hear.
Exactly!!! Buy buy buy, while we sell, sell, sell!
Ha Ha Ha Try this....
Buyout News! In the dark and conditional on ultra-positive Phase 3 results!
I hate when they pull that crap
Share offering after close thats what i smell ..Could drop to mid $20 or lower in the coming days
Float is 15.17M
Squeeze is coming around $37.75
Might have the power to hit $40 this session
Everybody is over at nwbo board waiting for phase 3 readout stock is 18 pennies go figure...
I agree
Long term this may be a great investment
Underline the word may
I had a limit order in at 17 when it was haulted
This is way overvalued IMO at this point in time
No lay up here
Remember this was the diet drug they pulled from the market
Caveat:
I may be more than wrong
That is for sure !
lol they were comparing it to the value of GW because of the similar drug.. So they bought too early
Can't believe folks shelled out $40. in PM.
everyone's looking and thinking whens the best buying opportunity lol
Guess shorts get to make some $ today
12.88 to 40$ id say pretty crazy ;)
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.
Full story: Zogenix cleared to start late-stage studies of lead product candidate in Dravet http://www.seekingalpha.com/news/2982746
Insider Money, December 12
ZGNX has 25 hedge funds with bullish positions and the amount invested in stocks is $158 million.
Relative to other companies with bullish positions (ie., NEOS, PBPB, CMTL), ZGNX might be a better candidate to consider a long position.
Full story: http://www.insidermonkey.com/blog/newbridge-bancorp-nbbc-hedge-funds-are-snapping-up-400098/?singlepage=1
$ZGNX recent news/filings
bullish 16.26
rallying off a base
lots of room to run upwards
moving average breakout
## source: finance.yahoo.com
Fri, 27 Nov 2015 17:18:18 GMT ~ Zogenix, Inc.: Strong price momentum but will it sustain?
read full: http://www.capitalcube.com/blog/index.php/zogenix-inc-strong-price-momentum-but-will-it-sustain/
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Thu, 26 Nov 2015 07:57:01 GMT ~ Is Potbelly Corp (PBPB) Going to Burn These Hedge Funds?
read full: http://www.insidermonkey.com/blog/is-potbelly-corp-pbpb-going-to-burn-these-hedge-funds-389477/
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Wed, 25 Nov 2015 21:18:00 GMT ~ Bears Must Bear With Upward Drift
read full: http://realmoney.thestreet.com/articles/11/25/2015/bears-must-bear-upward-drift?puc=yahoo&cm_ven=YAHOO
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Wed, 25 Nov 2015 15:40:00 GMT ~ Getting That Holiday Trading Feeling
read full: http://realmoney.thestreet.com/articles/11/25/2015/getting-holiday-trading-feeling?puc=yahoo&cm_ven=YAHOO
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Wed, 25 Nov 2015 13:00:00 GMT ~ New Data on Zogenix's ZX008 for Dravet Syndrome to be Presented at 69th Annual American Epilepsy Society Meeting
[GlobeNewswire] - Three Poster Presentations will Highlight Efficacy, Cardiovascular Safety and Mechanism of Action of Low-Dose Fenfluramine in the Treatment of Dravet Syndrome
read full: http://finance.yahoo.com/news/data-zogenixs-zx008-dravet-syndrome-130000243.html
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$ZGNX charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$ZGNX company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/ZGNX/company-info
Ticker: $ZGNX
OTC Market Place: Not Available
CIK code: not found
Company name: Zogenix, Inc.
Incorporated In:
Business Description:
$ZGNX share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: 19,170,468 a/o Jul 01, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$ZGNX extra dd links
Company name: Zogenix, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=ZGNX+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=ZGNX+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=ZGNX+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/news - http://finance.yahoo.com/q/h?s=ZGNX+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/ZGNX/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=ZGNX+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/ZGNX
DTCC (dtcc.com): http://search2.dtcc.com/?q=Zogenix%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Zogenix%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Zogenix%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/ZGNX
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=ZGNX&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=ZGNX
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=ZGNX+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=ZGNX+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=ZGNX
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=ZGNX
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=ZGNX+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/ZGNX/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=ZGNX+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/ZGNX.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=ZGNX
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/ZGNX
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/ZGNX
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/ZGNX:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=ZGNX
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=ZGNX
$ZGNX DD Notes ~ http://www.ddnotesmaker.com/ZGNX
Insiders buying these low prices of $13
$ZGNX recent news/filings
bullish
ascending triangle breakout
long term inverted head and shoulders
on balance volume and accumulation/distribution lines bullish
## source: finance.yahoo.com
Wed, 26 Aug 2015 17:28:48 GMT ~ Zogenix, Inc. Earnings Q2, 2015
read full: http://www.capitalcube.com/blog/index.php/zogenix-inc-earnings-q2-2015/
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Fri, 21 Aug 2015 17:04:14 GMT ~ ZOGENIX, INC. Financials
read full: http://finance.yahoo.com/q/is?s=zgnx
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Tue, 18 Aug 2015 20:05:09 GMT ~ ZOGENIX, INC. Files SEC form 8-K/A, Financial Statements and Exhibits
read full: http://biz.yahoo.com/e/150818/zgnx8-k_a.html
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Thu, 13 Aug 2015 00:12:20 GMT ~ 10-Q for Zogenix, Inc.
read full: http://www.companyspotlight.com/routers/headline/24333/10004/6557421?cp_code=YAH1&1439424740
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Tue, 11 Aug 2015 18:26:38 GMT ~ 4 More Biotechs Leerink Is Looking At Post-Earnings
read full: http://finance.yahoo.com/news/4-more-biotechs-leerink-looking-182638971.html
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$ZGNX charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$ZGNX company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/ZGNX/company-info
Ticker: $ZGNX
OTC Market Place: Not Available
CIK code: not found
Company name: Zogenix, Inc.
Incorporated In:
Business Description:
$ZGNX share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: 19,170,468 a/o Jul 01, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$ZGNX extra dd links
Company name: Zogenix, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=ZGNX+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=ZGNX+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=ZGNX+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/news - http://finance.yahoo.com/q/h?s=ZGNX+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/ZGNX/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=ZGNX+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/ZGNX
DTCC (dtcc.com): http://search2.dtcc.com/?q=Zogenix%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Zogenix%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Zogenix%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/ZGNX
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=ZGNX&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=ZGNX
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=ZGNX+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=ZGNX+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=ZGNX
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=ZGNX
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=ZGNX+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/ZGNX/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=ZGNX+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/ZGNX.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=ZGNX
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/ZGNX/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/ZGNX/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/ZGNX
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/ZGNX
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/ZGNX:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=ZGNX
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=ZGNX
$ZGNX DD Notes ~ http://www.ddnotesmaker.com/ZGNX
ZGNXs competition:
Elite Pharma( ELTP ) had successful results from a pilot bioequivalence study for ELI-201, a TWICE-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. $$$ THREE $$$ different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.
Next year Elite will have the ONLY Immediate Release Abuse Labeled Oxycodone ELI-200
What a disappointment (daily). $12 target value IMO.
They wasted no time....
What's in the dark....
Eventually manifests itself in the light....
Blessings to All
TRUTH
They work like a pink sheet stock. Reverse split, then dilute and sell more shares. Not good for the common investor.
RS made my portfolio small, any increase in share price is minimal now. This was doing just fine before the split. Only difference is now I'm left with 62 shares instead of 500. Same price swings, really. Reverse splits blow chunks.
This DCF is only accounting for ZX-008, not any Zohydro payments nor (more importantly) Relday, which has p2 results coming soon. $28 may ultimately still prove conservative...all Brean really did was increase operating margin to that in line with other orphan drug producing companies and increase likelihood of approval from 70% -> 80%.
R/S is working like a charm, attracting more investors and tuning up for a huge run here
Zogenix (ZGNX) PT Raised to $28 at Brean Capital; ZX008 Finally Being Appreciated
July 15, 2015 8:11 AM EDT
Click For Link
Brean Capital analyst Difei Yang reiterated a Buy rating and boosted his price target on Zogenix, Inc. (NASDAQ: ZGNX) to $28.00 (from $20.00), saying investors are finally beginning to appreciate ZX008.
Yang commented, "Zogenix shares have shown strength during the days leading up to yesterday's KOL investor breakfast day. We believe ZX008 has finally begun to be appreciated by investors. As we have have said before, we believe ZX008 for Dravet syndrome is potentially a more efficacious drug than the competing compound from GW Pharma.
Based on the detailed discussion from yesterday's KOL investor meeting, we revisited the assumptions used in the calculations for our TP and made two positive revisions. This leads us to increase our TP from $20 to $28."
Shares of Zogenix, Inc. closed at $17.69 yesterday.
Blessings to All
TRUTH
Zogenix Delays Epilepsy Drug Trials By Three Months
2 Hours Ago (Reporting by Anjali Rao Koppala in Bengaluru; Editing by Savio D'Souza and Simon Jennings)
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July 14 (Reuters) - Drug developer Zogenix Inc said on Tuesday that it would push back late-stage trials of its treatment for a rare form of epilepsy by about three months to enroll more patients.
The company said it now planned to begin late-stage trials of the drug, ZX008, in the fourth quarter, and would seek to enroll 105 patients in the studies, up from 40 to 60 earlier, acting on guidance from the U.S. Food and Drug Administration.
The drug is aimed at treating children with Dravet syndrome, a rare form of epilepsy that begins in infancy. Patients suffer from potentially fatal, long-lasting, fever-related seizures that do not respond to standard medication.
Investors held to the stock after the company's decision to expand and delay the study.
Zogenix's shares, which have gained 44 percent so far this year, were up 4 percent in morning trading after touching a year-high of $16.60 earlier.
Stifel Nicolaus analyst Annabel Samimy said the slip in timing was not "dramatically different," and that she expected the company's investigational new drug (IND) application to be approved within 30-60 days.
Zogenix acquired ZX008 when it bought U.K.-based private company Brabant Pharma in October 2014. The treatment currently has orphan drug status in the United States and Europe.
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Analyst Rating Update on Zogenix, Inc.
Phil Early July 10, 2015
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Research firm Zacks has rated Zogenix Inc (NASDAQ:ZGNX) and has ranked it at 3, indicating that for the short term the shares are a hold. 6 Wall Street analysts have given the company an average rating of 1.33. The shares has received a hold rating based on the suggestion from 1 analysts in latest recommendations. Strong buy was given by 5 Wall Street Analysts.
Company has received price target recommendation from many analysts. Piper Jaffray initiates coverage on Zogenix, Inc. (NASDAQ:ZGNX). In the latest research report, Piper Jaffray announces the target price to $2.5 per share on the shares. According to the latest information available, the shares are now rated Overweight by the analysts at the agency. The rating by the firm was issued on April 22, 2015.
Zogenix, Inc. (NASDAQ:ZGNX): According to 5 Analysts, The short term target price has been estimated at $ 22.4.The target price could deviate by a maximum of $3.58 from the forecast price. In the near term, the target price could hit a high of $28 and a low of $ 20.
Zogenix, Inc. (NASDAQ:ZGNX) : On Thursday heightened volatility was witnessed in Zogenix, Inc. (NASDAQ:ZGNX) which led to swings in the share price. The shares opened for trading at $13.16 and hit $13.36 on the upside , eventually ending the session at $13.22, with a gain of 1.85% or 0.24 points. The heightened volatility saw the trading volume jump to 725,397 shares. The 52-week high of the share price is $15.68 and the company has a market cap of $253 million. The 52-week low of the share price is at $8.56 .
Zogenix, Inc. has dropped 5.3% in the last five trading days, however, the shares have posted positive gains of 1.38% in the last 4 weeks. Zogenix, Inc. is up 11.66% in the last 3-month period. Year-to-Date the stock performance stands at 20.62%.
Zogenix, Inc. (Zogenix) is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Its lead product candidate, Zohydro (hydrocodone bitartrate, formerly ZX002) is a 12-hour extended-release formulation of hydrocodone without acetaminophen for the treatment of chronic pain requiring opioid therapy.
It completed Phase 3 development of Zohydro in 2011. Its second DosePro investigational product candidate, Relday, is a injectable formulation of risperidone for the treatment of schizophrenia. In April 2014, Endo International PLC acquired worldwide rights to Sumavel DosePro (sumatriptan injection) for subcutaneous use, a needle-free delivery system for sumatriptan, from Zogenix, Inc.
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