ZGNX nächster Turnaroundwert mit großem Potential

TICKER: ZGNX
Kurs: $1.65
Börse: Nasdaq
Mein Kursziel: $ 5.00
52-Week High: $ 6.90
Mkt Cap (Mil) 107.55
Shares Out (Mil) 65.18
Float (Mil) 11.24
Insider buys: http://www.insidercow.com/history/....jsp?company=zgnx&B1=Search!





 

 

 

DD on ZGNX 100 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug doing 40 mill in sales 2011 & projected to do 80 mill in 2012 BUT their big dollar drug has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone ( Over 6 Billion Dollars a Year ) & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout..INSANE Valuation here  

ZGNX hat noch ein GAP bei $2.60 . Diese Marke sehe ich hier als erstes Kursziel.  

http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-IRHome  

From S.E.C. filing of latest 10Q

As of September 30, 2011, we had cash and cash equivalents of $70.8 million. We believe that our cash and cash equivalents as of September 30, 2011, together with future revenue and borrowings available under our $10.0 million revolving credit facility, will be sufficient to fund our operations into the second quarter of 2013.  

Fast unmöglich Aktien vom bid bei $1.80 zu ergattern. Das Ding ist so markteng gehandelt.
Angeblich sind nur noch 4M im Float , da Investoren in den letzten Monaten zugegriffen haben.
Stimmt das , dann wäre fast jede vierte Aktie des Floats short.
Aktuelle Shortzahl beläuft sich auf 951,117 Aktien.  

 

ZGNX news - Zogenix Completes Zohydro(TM) Pre-NDA Meetings With FDA
Zohydro NDA Submission on Track

SAN DIEGO, Dec. 20, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has concluded its pre-New Drug Application (NDA) meetings with the U.S. Food & Drug Administration (FDA) related to its lead investigational product candidate, Zohydro(TM) (hydrocodone bitartrate extended-release capsules). The purpose of the meetings was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Zohydro, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. After a detailed review of the submission timeline, Zogenix plans to submit the NDA for Zohydro early in the second quarter of 2012.

Stephen Farr, PhD, president and chief operating officer of Zogenix, said, "The completion of our pre-NDA meetings with the FDA brings us one more important step closer to potentially gaining approval for Zohydro. We appreciate the informative interactions, timeliness, and clarity provided by the FDA, as well as the full support of Alkermes, our CMC partner, in the pre-NDA meeting process."

Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.

Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to provide consistent 12-hour pain relief, without exposure to acetaminophen, will position the product well in this large market.

About Zohydro

Zohydro is a novel, oral, single entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. When used in high dosages over time, acetaminophen can cause liver toxicity. If approved, Zohydro could be the first single-entity hydrocodone therapy available. Zohydro uses Alkermes' patented Spheriodal Oral Drug Absorption System (SODAS(R)) drug delivery technology which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate release combination products. Capsule strengths utilized in the Phase 3 studies included 10, 20, 30, 40 and 50 mg capsules.

About Chronic Pain

The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. Chronic pain can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the U.S., generating $3.2 billion in sales during the 12 months ended December 2010 (Wolters Kluwer Pharma Solutions, Source Pharmaceutical Audit Suite Retail, January 2010 -- December 2010). All of these hydrocodone products contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver toxicity when used in high dosages over time.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX - News), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL(R) DosePro(R) (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro(TM) (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the management of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second investigational DosePro product candidate, Relday(TM), is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the potential for, and timing of, an NDA submission for Zohydro; the potential for Zohydro to be the first approved oral, single-entity extended-release formulation of hydrocodone; and the size of the opioid pain market and the potential of Zohydro to be well positioned in that market. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the top-line data Zogenix has reported for Zohydro is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial, and may also change in connection with the continued review of such data as part of Zogenix's planned submission and the FDA's review of the NDA for Zohydro; the progress, timing and results of the planned bioequivalence study for Zohydro; the potential that earlier clinical trials may not be predictive of future results; the potential for Zohydro to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Zohydro to delay or prevent regulatory approval or commercialization; the impact of any inability to raise sufficient capital to fund ongoing operations; the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates and the ability to operate its business without infringing the intellectual property rights of others; and other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

SODAS(R) is a trademark of Alkermes plc.

SUMAVEL(R), DosePro(R), ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.




Contact:
INVESTORS:Zack Kubow | The Ruth Group646.536.7020 | zkubow@theruthgroup.comMEDIA:Victoria Aguiar | The Ruth Group646.536.7013 | vaguiar@theruthgroup.com  

Zogenix, Astellas To End Co-Promotion Agreement For Sumavel Drug

Pharmaceutical company Zogenix Inc. (ZGNX) said it agreed to end its co-promotion of the Sumavel DosePro needle-free delivery system with Astellas Pharma U.S. Inc., a U.S. subsidiary of Astellas Pharma Inc. (4503.TO), on March 31 next year.

Sumavel DosePro is Zogenix's first commercial product and was launched with Astellas in January of last year to treat migraines and cluster headaches. Zogenix develops drugs for the treatment of nervous system disorders and pain.

Beginning in the second quarter of 2012, Zogenix will assume full responsibility for the commercialization of Sumavel, focusing on headache specialists, neurologists and primary care physicians who treat a lot of migraine patients.

Zogenix Chief Executive Roger Hawley said ending the co-promotion will lower its expenses, since Zogenix will no longer pay a service fee to Astellas beginning in the second quarter of 2012. He said the company is exploring the potential of modestly expanding its sales force and considering other Sumavel promotion partners.

Neither company will incur a penalty payment for terminating the agreement, which was originally slated to expire in June 2013. The companies plan to agree on a detailed customer transition plan by February next year, with the goal of uninterrupted access and service to physicians receiving the drug from Astellas.

Last month, Zogenix said its third-quarter loss edged lower on higher sales of Sumavel.

Shares closed Tuesday at $1.60 and were inactive premarket. The stock is down 72% year to date.

-By Ben Fox Rubin, Dow Jones Newswires; 212-416-3108; ben.rubin@dowjones.com;  

ZGNX on ABC " 'Zo-Hydro' Contains Pure Hydrocodone"
http://abcnews.go.com/WNT/video/zohydro-pure-hydrocodone-15270600.  

Top Biotech Pick For 2012: Zogenix ( ZGNX )
http://seekingalpha.com/article/...-top-biotech-pick-for-2012-zogenix  

$ZGNX $3.00 new high of day - Moneymaker Pick Price: $ 1.65  

Kannst du mir erklären, woher dieser Aktienabsturz ab Ende Juli 2012 kommt?

Die Quartals-Zahlen waren doch nicht so schlecht.  

Zogenix (NASDAQ: ZGNX) is now covered by analysts at William Blair. The analysts set an “outperform” rating and a $6.00 price target on the stock.  

Du meintest sicher Ende Juli 2011 .
ZGNX hat eine Kapitalerhöhung durchgeführt , das war der Grund.  

Bodenbildung zwischen $2.50 und $2.60 wird gerade gebildet.
Ideale Chance für Neueinstiege imo  

Ich rechne aktuell damit, dass ZGNX noch einmal die MA50er Tageslinie testen wird.  

Ich kann mir nicht vorstellen, dass das Unternehmen auf dem aktuellen Niveau bei $2.50 Aktien in den Markt werfen wird.
Das Filing wurde in weiser Voraussicht erstellt , um bei weitaus höheren Kursen Kapital zu generieren.

We may from time to time offer to sell any combination of debt securities, preferred stock, common stock, debt warrants and equity warrants described in this prospectus, either individually or in units, in one or more offerings. The aggregate initial offering price of all securities sold under this prospectus will not exceed $75,000,000.

This prospectus provides a general description of the securities we may offer. Each time we sell securities, we will provide specific terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or change information contained in this prospectus. You should read this prospectus and the applicable prospectus supplement carefully before you invest in any securities. This prospectus may not be used to consummate a sale of securities unless accompanied by the applicable prospectus supplement.

We will sell these securities directly to our stockholders or to purchasers or through agents on our behalf or through underwriters or dealers as designated from time to time. If any agents or underwriters are involved in the sale of any of these securities, the applicable prospectus supplement will provide the names of the agents or underwriters and any applicable fees, commissions or discounts.

Our common stock is traded on the Nasdaq Global Market under the symbol “ZGNX.” On February 2, 2012, the closing price of our common stock was $2.74.

http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8375245  

gehandelt! Viel Volumen war hier noch nie wirklich drin in Frankfurt etc.

Denke, dass das Potential wird irgendwann erkannt werden! Spätestens, wenn der FDA Termin näher kommt =)

 

Glaub ich trink erstmal nen Kaffee =)

 

 

http://www.nasdaq.com/symbol/zgnx/real-time