Zogenix (ZGNX)

[ppl_first]

RS 8:1 in effect today, then quick fall from $14 back to $6 back to $1.

[SPM555]

$ZGNX's chart is looking promising.

http://chartdiligence.com/zgnx-biotech-play-with-bullish-consolidation/

[TRUISM]

CAN ZOGENIX, INC. (NASDAQ:ZGNX) SURPRISE ANALYSTS THIS QUARTER?
on JUNE 2, 2015
Click For Link





Earnings surprises occur when a company’s actual reported earnings differ from the consensus analyst estimates. A positive or negative earnings surprise can often result in significant stock price movement immediately after the earnings announcement, but can also have a long-term effect as well.

In the most recent quarter, Zogenix, Inc. (NASDAQ:ZGNX) reported an earnings surprise of 38.46% when the firm last announced their results for the period ending on 2015-06-30. The actual earnings per share number of $-0.08 was $0.05 away from the consensus analyst number.

Zogenix, Inc. (NASDAQ:ZGNX) will next issue their quarterly earnings announcement on 2015-08-04. Brokerage firm analysts surveyed by Zacks research are estimating earnings of $0 per share. This is the consensus number calculated from the 5 polled analysts taken into consideration by Zacks. Institutions and investors alike will be closely monitoring estimate revisions of the EPS numbers leading up to the expected results date.

Stock Price Target

Sell-side firms covering the equity are estimating that the stock will reach $2.8 on a short-term basis. This is the mean estimate based on the 5 brokerage analysts surveyed by Zacks. The most bullish analyst sees the stock reaching 3.5 while the most conservative target is set at $2.5.

By simplifying the analyst ratings into a 1 to 5 scale where 1 represents a Strong Buy and 5 a Strong Sell, Zogenix, Inc. has a rating of 1.33 . This is the arithmetic mean of all the analyst estimates taken into consideration by Zacks. When the same analysts were polled three months ago, the rating was at 1.33.

Zogenix, Inc. (Zogenix) is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. The Company’s product Sumavel DosePro offers needle-free subcutaneous administration of sumatriptan for the treatment of migraine and cluster headache in a pre-filled, single-use delivery system.

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. Sumavel DosePro and Zohydro are used for the treatment options available to patients and physicians in the United States. Its second DosePro investigational product candidate, Relday, is a injectable formulation of risperidone for the treatment of schizophrenia. In May, 2012, it submitted a New Drug Application to the Food and Drug Administration (FDA).




Blessings to All

TRUTH

[ppl_first]

Come on 1.83 so I can sell this junk!

[WealthyKing]

ZGNX-looking good after buying in on the 1.40 break

[TRUISM]

Brean Capital Maintains Buy on Zogenix, Inc. (ZGNX) Following New Data on Dravet Syndrome
May 28, 2015 2:21 PM EDT by Jason Cohen, Editor
Click For Link



In a research report released Thursday, Brean Capital analyst Difei Yang maintained a Buy rating on Zogenix, Inc. (NASDAQ:ZGNX) with a price target of $2.50, after new clinical data presented at the European Paediatric Neurology Society meeting this week on Dravet Syndrome. Zogenix shares are currently trading at $1.50 up $0.03 or 2.04 percent.

Yang observed, “This analysis, which includes ten patients from the original study group (as published in 2012) and two new patients who began treatment in 2011, showed that at least 80% of patients achieved a greater than or equal to 75% reduction in the frequency of seizures during the annual follow-up visits. The data further supported the long-term efficacy of low dose fenfluramine as observed in previous studies.”

“In our view, Zogenix is significantly undervalued since ZX008 is a low-risk Phase III asset. Two things we would like to point out: 1). few compounds in Phase III development have the type of longitudinal clinical data as ZX008 has; and 2). on relative valuation, Zogenix clearly lags behind its competitor GW Pharmaceuticals.”, the analyst added.

According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Difei Yang has a total average return of 16.2% and a 69.4% success rate. Yang has a 12.2% average return when recommending ZGNX, and is ranked #381 out of 3610 analysts.






Blessings to All

TRUTH

[TRUISM]

Zogenix Announces New Efficacy Data From A Long-Term Study Of Low-Dose Fenfluramine For Treatment Of Dravet Syndrome
May 27, 2015: 08:30 AM ET
Click For PR




New data presented at European Paediatric Neurology Society Congress in Vienna, Austria includes 10 patients who continued treatment with low-dose fenfluramine for Dravet syndrome following the original study published in 2012, plus 2 new patients who began treatment in 2011
During 5-year follow-up period from 2010-2014:

At least 80% of patients experienced a greater than or equal to 75% reduction in seizure frequency every year

A majority of patients experienced long periods of seizure freedom
The drug was well tolerated and no patient discontinued treatment due to adverse events
SAN DIEGO, May 27, 2015 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing unique therapies for the treatment of central nervous system (CNS) disorders, today announced new data demonstrating sustained efficacy and tolerability for patients treated with low-dose fenfluramine as an adjunctive therapy for Dravet syndrome.

The data was authored by world-renown experts in the field of Dravet syndrome, Berten Ceulemans, M.D., Ph.D. and Lieven Lagae, M.D., Ph.D., from the Universities of Antwerp and Leuven in Belgium, and was presented at the European Paediatric Neurology Society meeting taking place this week in Vienna, Austria (see study data here). Zogenix intends to initiate Phase 3 clinical studies for ZX008, the Company's investigational proprietary pediatric formulation of low-dose fenfluramine, during the second half of 2015. ZX008 is designated as an orphan drug in both the U.S. and Europe for the treatment of Dravet syndrome.


Clinical Efficacy Data


Patients with Dravet syndrome experience frequent, severe and potentially life-threatening seizures that typically start in the first year of life. These seizures do not respond to standard anti-epileptic medications and current treatment options are very limited.

"The most important element of treating patients with Dravet syndrome is to reduce the frequency of all seizures and to prevent status epilepticus, which is a continuous state of seizure," said Prof. Berten Ceulemans. "As this most recent data analysis demonstrates, in our experience, we have been able to achieve major seizure control for Dravet syndrome patients using a low-dosage form of fenfluramine as adjunctive therapy. It is my hope that these outcomes will be replicated in the Phase 3 program to be undertaken by Zogenix."

"We continue to be encouraged by the results of the ongoing open-label study of the use of low-dose fenfluramine in patients with Dravet syndrome. It is very exciting to observe a reduction of greater than or equal to 75% in seizure frequency for at least 80% of patients over the latest 5-year follow-up period with the use of fenfluramine as an add-on treatment. In addition, there continues to be a majority of Dravet patients who experience sustained periods of seizure-freedom.

We believe these data represent the most robust, long-term data set of any investigational treatment for Dravet syndrome, especially since some of these patients have been treated for well over 20 years," said Stephen Farr, Ph.D., Chief Executive Officer of Zogenix. Farr continued, "Our current focus is to finalize the Phase 3 study protocol, based on recent feedback received from the U.S. Food and Drug Administration, and initiate the studies of ZX008 in the U.S. and Europe."
The results presented are from the latest 5-year follow-up period (2010-2014) in a group of Dravet syndrome patients being treated with low-dose fenfluramine (10 mg to 20 mg per day).

This analysis, which includes ten patients from the original study group (as published in 20121) and two patients who began treatment in 2011, demonstrated that during any given year of the follow-up period, at least 80% of patients achieved a greater than or equal to 75% reduction in the frequency of seizures. In addition, three patients (25%) were seizure-free for all 5 years and five patients (42%) were seizure-free for 2 to 4 years. The use of low-dose fenfluramine in this group of patients was shown to be generally well tolerated, with the most common adverse events being transient loss of appetite and fatigue/somnolence. No clinically meaningful cardiac adverse events were noted. No patient discontinued treatment due to adverse events.

In addition, a recently published translational research study2 to elucidate fenfluramine's mechanism of action in Dravet syndrome demonstrated the ability of fenfluramine to significantly reduce locomotion and eliminate epileptiform EEG activity in a gene knockdown zebrafish model of Dravet syndrome. These data support the clinical results obtained in the Belgium cohort of patients.

Clinical Efficacy Data
Categorical response to low-dose fenfluramine in Dravet syndrome patients:
http://media.globenewswire.com/cache/35369/file/34413.pdf

Clinical Safety Data
Cardiovascular evaluations, including echocardiogram every 3 months during Year 1, every 6 months during Year 2, and annually thereafter, demonstrated: Valvular thickening observed at only 1 examination in 5 patients and not seen at any other examination; observed 4 times in one patient, but was normal at most recent examination.

No cases of pulmonary hypertension were observed

None of these patients exhibited clinical signs or symptoms associated with valvular thickening or restrictive valve disease

Other adverse events included transient loss of appetite, fatigue/somnolence, mild obesity, and behavior problems in a minority of patients.

About ZX008
ZX008 is a low-dose fenfluramine formulated for pediatric use and is currently under evaluation for the reduction of seizures in Dravet syndrome patients. Fenfluramine was originally developed and approved as an anoretic agent for the treatment of obesity. Although fenfluramine was withdrawn from the market in 1997 due to risk in the indicated patient population of serious heart valve defects, preclinical and clinical evidence of the drug's ability to abolish epileptic seizures had previously been described.

In Belgium, under a Royal Decree, the anticonvulsive effects of fenfluramine continued to be evaluated using the limited supply of drug in a clinical trial involving a small group of patients diagnosed with Dravet syndrome. The study is continuing today with fenfluramine sourced by Zogenix, manufactured from a synthetic process consistent with current regulatory standards for drug substances; both clinical and commercial supply manufacturers have now been selected. ZX008 has been granted orphan drug designation by regulatory agencies in the U.S. and Europe, and an application is pending in Japan. Phase 3 clinical studies will be initiated by Zogenix in the second half of 2015 with New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions targeted for the fourth quarter of 2016.

About Dravet Syndrome
Dravet syndrome (also known as Severe Myoclonic Epilepsy of Infancy) is a rare, severe and therapy-resistant form of epilepsy most often caused by an identifiable gene defect that results in abnormal functioning of a sodium channel in the brain. Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life. Other seizures typically arise later, including myoclonus (involuntary muscle spasms) and status epilepticus (prolonged seizures), which often result in severe cognitive and developmental impairment. Episodes of status epilepticus require immediate emergency care and can be fatal.

Individuals with Dravet syndrome face a higher incidence of SUDEP (sudden unexplained death in epilepsy) and have associated conditions, which also require proper treatment and management. Children with Dravet syndrome do not outgrow this condition and it affects every aspect of their daily lives.

About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.
For more information, visit www.zogenix.com.



Blessings to Al

TRUTH

[skydog526]

Where is everyone?

Crickets

[TRUISM]

Turnaround Tuesday: Struggling Drug Maker Zogenix Sells Unit, Refocuses
BY ALLISON COLLINS May 5, 2015
Click For Link


UPDATED -- The sale, which comes with up to $283.5M in additional payments, allows the company to focus on developing a schizophrenia medication

UPDATED -- Struggling drugmaker Zoegenix Inc. (Nasdaq: ZGNX) has sold its Zohydro ER business, which makes painkillers, to Pernix Therapeutics Holdings Inc. (Nasdaq: PTX) for $80 million.


Zohydro ER is an extended-release, opioid-derived medication for pain management. As Mergers & Acquisitiosn previously reported, Zogenix won a lawsuit in 2014 to sell the medication in Massachusetts after former Gov. Deval Patrick issued an executive order prohibiting its sale, saying that it could lead to drug-abuse problems. Opioid-based painkillers have been widely linked the resurgence of heroin in the U.S.

The sale of Zohydro also comes with the possibility for Zogenix to receive up to $283.5 million in additional cash payments based in milestones, including $12.5 million if the U.S. Food & Drug Administration approves an abuse-deterrent, extended-release hydrocodone tablet that is in development right now. The FDA already approved Zohydro.

San Diego-based Zogenix is also shedding 100 employees through the deal, which will transfer over to Pernix. The company also plans to cut 16 more jobs because of the sale, it says, and will end up with about 60 employees.

Pernix is making the acquisition through subsidiary Ferrimill Ltd. The new owner says it will actively work to develop the abuse-deterrent medication. Leerink Partners LLC was Zogenix's financial adviser, and Latham & Watkins LLP provided legal advice for the transaction, which closed April 24.

The divestiture allows Zogenix to significantly reduce its operating expenses. The company is planning to use proceeds from the sale to fund development of Relday, a schizophrenia drug.

"With the upfront proceeds from this transaction, and without assuming future milestone payments related to Zohydro ER, the Company plans to use the capital to fund the current Relday clinical program to the end of Phase 2 meeting with the [FDA]," says Catherine O'Connor, Zogenix's senior director of corporate communications.

As part of the sale, lenders Oxford Finance LLC and Silicon Valley Bank amended Zogenix's loan to add a covenant that requires the business to maintain a liquidity ratio of 1.25 to 1, according to a filing with the U.S. Securities and Exchange Commission.

Zogenix has incurred recurring losses from operations and negative cash flows, which caused its accountant, Ernst & Young, to raise substantial doubt about the company's ability to continue as a going concern, or without the threat of liquidation, according to a SEC filing. The company has functioned primarily through equity and debt financings, and has raised $417.5 million from stock sales.



Blessings to All

TRUTH

[TRUISM]

Pernix Launches Zohydro® ER with BeadTek™
Published: May 4, 2015 8:00 a.m. ET
Click For Link To PR

New Formulation Maintains 12-Hour Efficacy to Treat Patients Suffering from Chronic Pain



MORRISTOWN, N.J., May 04, 2015 (BUSINESS WIRE) -- Pernix Therapeutics Holdings, Inc. PTX, +4.55% a specialty pharmaceutical company, today announced that the new formulation of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™ is now available in U.S. pharmacies.

On January 30, 2015, the U.S. Food and Drug Administration (FDA) approved this updated formulation that features BeadTek, a technology encompassing an indistinguishable mix of inactive beads, active immediate-release hydrocodone beads and active extended-release hydrocodone beads.

Zohydro ER with BeadTek delivers an extended release of hydrocodone that provides 12-hour dose duration. When taken as directed, the inactive beads contained in Zohydro ER with BeadTek remain inert. The inactive beads dissolve independently of the active hydrocodone beads and are designed not to change the 12-hour release properties of the medication when taken as directed. However, when crushed and dissolved in liquids or solvents, the inactive beads are designed to immediately form a viscous gel.

"Zohydro ER with BeadTek represents an advancement for clinicians and their patients living with, chronic pain, demonstrating effective relief over the 12-hour dose duration,” said Srinivas Nalamachu, MD, president and medical director, International Clinical Research Institute, Overland Park, Kansas and lead author of a clinical study evaluating the long-acting pain relief of Zohydro ER. "Research demonstrated significant rates in pain reduction with no pattern of end-of-dose failure, as well as significantly improved disability scores in patients taking Zohydro ER with BeadTek.”

Zohydro ER with BeadTek is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Zohydro ER does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. Zohydro ER with BeadTek will be available in strengths 10 mg, 15mg, 20mg, 30mg, 40 mg and 50 mg.

“Zohydro ER is an ideal strategic fit for Pernix, having tremendous synergy with our existing CNS franchise. It also represents a major step forward in our strategy to expand our commercial reach, and we expect it to create significant value for our shareholders,” said Douglas Drysdale, Chairman, President and Chief Executive Officer of Pernix Therapeutics.

“Adding Zohydro ER with BeadTek strengthens our specialty product portfolio and brings the proven clinical benefits of Zohydro ER to patients suffering with chronic pain in need of around-the-clock opioid therapy.”

As part of the acquisition, announced on March 10, 2015, Pernix has retained key members of Zogenix’s commercial team, who will oversee the sales and marketing of Zohydro ER with BeadTek, most notably the approximately 100-person sales team. The new Pernix Pain Management sales team will immediately promote both Zohydro ER with BeadTek and Silenor®.

Approximately two-thirds of patients experiencing chronic pain report having poor or unrefreshing sleep. Silenor, the only non-scheduled, non-addictive prescription medication for insomnia, prov
ides a valuable option for patients already taking a scheduled medication for pain relief.



Blessings to All

TRUTH

[ppl_first]

WTF just happened? Why was this chugging along all nice & pretty at $1.65 and now it is stair-stepping diagonally down? WHY?

[ryan44]

SAN DIEGO , April 24, 2015 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that it has closed the sale of its Zohydro® ER (hydrocodone bitartrate) business to a wholly-owned subsidiary of Pernix Therapeutics Holdings, Inc. (Nasdaq:PTX) for $80 million in cash, approximately 1.68 million shares of Pernix common stock, plus regulatory and sales milestones of up to $283.5 million .

[Bullsonmonday]

good bounce back today, should close higher tomorrow assuming the market isn't wacky

[TRUISM]

Closing Bell Reports:Zogenix, Inc. (ZGNX)-Excerpt
by Matt Collette - Apr 20, 2015 6:04 pm EDT
Click For Link



Zogenix, Inc. (ZGNX) finished up today at $1.62 with a volume of 1,254,626 shares, changing by 2.53% ( 0.620% change from open) with a profit margin of 21.50%. The return on investment for Zogenix, Inc. (ZGNX) is currently-27.30% and Zogenix, Inc. (ZGNX)’s weekly performance is 6.04%. Zogenix, Inc. (ZGNX)’s monthly performance stands at 16.18% with current market cap of 242.29million and insider ownership of 0.90% in the Healthcare sector of the Drug Manufacturers – Major industry.








TRUTH

[TRUISM]

Sub $2 Biotech Stocks On The Move-Zogenix Excerpt
Bret Jensen,Apr. 16, 2015 3:29 PM ET
Click For seekingalpha.com Link



Zogenix (NASDAQ:ZGNX). This small biopharma was primarily focused on developing therapies that address specific clinical needs for people living with CNS (Central Nervous System) and pain-related conditions that need innovative treatment alternatives to help them return to normal daily functioning.

The company's main product was Zohydro. This is a compound for chronic severe pain sufferers who have issues with other extended-release opioid medications such as OxyContin and hydrocodone (Vicodin).

This population is believed to be some 2.5 million just in the United States. After getting an extended abuse resistant version of Zohyrdro approved by the FDA earlier this year, the company made a momentous decision for the company.

Zogenix decided to sell the rights to Zohydro to Pernix Therapeutics Holdings (NASDAQ:PTX) recently. As part of the deal, Zogenix will transfer Zohydro sales team to Pernix. That will slash its employee count to 60 from 200 and reduce operational costs substantially. The company will receive $100 million in upfront payments for selling Zohyrdo to Pernix.

It could also earn more than $250 million more in milestone payments if Zohyrdo hits certain regulatory and sales goals. To put in perspective, the company has a current market capitalization of approximately $250 million.

Zogenix still has a few "shots on goal". The company has a proprietary once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia in phase II trials. Finally, it recently purchased a compound that could potentially be a treatment for Dravet syndrome that will soon start Phase III trials.

Zogenix had some $50 million in net cash on the books before the sale of Zohydro to Pernix. The stock currently sells for $1.60 a share after dipping to $1.20 a share on the overreaction of the sale. The five analysts that cover the stock have price targets ranging from $2.25 to $3.50 a share on ZGNX.





TRUTH

[BAD HEMPER]

Looks healthy today

[paladin551]

Analysts at Zacks have given a short term rating of hold on Zogenix Inc (NASDAQ:ZGNX) with a rank of 3. The company has received an average rating of 1.4 from 5 brokerage firms. 4 analysts have rated the company as a strong buy. The company has been rated as hold from 1 Wall Street Analysts.

Company has received coverage from different analysts. Empire Asset Management initiates coverage on Zogenix, Inc. (NASDAQ:ZGNX). Empire Asset Management has a Buy rating on the counter. As per the latest report, the brokerage house announces the price target to $5 per share.

Zogenix, Inc. (NASDAQ:ZGNX) recorded a 10.17% change in the short interest in the past month. The 3-month %change in short interest stands at 11.95%. The monthly shorted shares now measure at 0.1838 times the total shares outstanding. The companys short ratio is at 5.13. The average volume for the past 20 trading days is 5,223,443 shares. Volume for the last 20 trading sessions stands at 3.41% of the outstanding shares.

[BAD HEMPER]

MOVE COMING HERE. Nice and steady

[ClayTrader]

* * $ZGNX Video Chart 04-13-15 * *

Link to Video - click here to watch the technical chart video

[TRUISM]

Morning Buzz:Zogenix, Inc. (ZGNX)
by Jim Berger - Apr 13, 2015 10:13 am EDT
Click For Zogenix Excerpt



Zogenix, Inc. (ZGNX) of the Healthcare is up 3.36% this morning at $1.54 and 456694 shares. The return on investment for Zogenix, Inc. (ZGNX) is currently -27.30% and weekly performance of 1.360%. Zogenix, Inc. (ZGNX)’S monthly performance stands at 22.130% with an analyst rating of 1.4









TRUTH

[TRUISM]

My thoughts exactly.




TRUTH

[2014shelby]

Let's hope it's 4

[TRUISM]

Brokerage Firm Price Target on Zogenix, Inc.
Brian Robert April 10, 2015
Click For Link



Zogenix, Inc. (NASDAQ:ZGNX) shares are expected to touch $2.75 in the short term. This short term price target has been shared by 5 analysts. However, the standard deviation of short term price estimate has been valued at 0.5. The target price could hit $4 on the higher end and $2 on the lower end.

Company has received coverage from different analysts. Equity analysts at the Brokerage firm William Blair downgrades its rating on Zogenix, Inc. (NASDAQ:ZGNX). The rating major has initiated the coverage with an market perform rating on the shares. Earlier, the shares were rated a Outperform by the brokerage firm.

Zogenix, Inc. (NASDAQ:ZGNX), A sharp increase of 1,633,388 shares or 6.2% was observed in the short interest of Zogenix, Inc. The interest on March 13,2015 came in at 28,195,078 shares and as per the average daily trading of 8,079,082 shares, the days to cover are 3. The increased interest is 21.1% of the floated shares. The data of February 27,2015 put the interest at 26,561,690 shares.





TRUTH

[paladin551]

Sometimes I find myself looking for the 'LIKE' button, a la Facebook.........

[2014shelby]

Thanks for the info

[TRUISM]

FDA Issues Final Guidance On Abuse-Deterrent Opioids
By Nicole Gray | April 2, 2015
Click For Link






Dive Brief:

* New guidance from the FDA focuses heavily on which studies best demonstrate whether an opioid can be considered abuse deterrent—however, the agency emphasizes that abuse-proof opioids don't exist. There are four categories of study.

* The FDA convened a public meeting on October 30-31, 2014 to discuss the development, assessment and regulation of abuse-deterrent formulations of opioid medications.

* The FDA concedes that the science of abuse-deterrent technology is still evolving.

Dive Insight:

According to the World Health Organization, approximately two million Americans are addicted to opiates, while the the Institute of Medicine estimates that 100 million Americans suffer from chronic pain.

Some of these patients have chronic pain that can only be alleviated with the sort of daily, around-the-clock, long-term opioid treatment that is ripe for abuse. The unfortunate reality is that prescription opioid abuse kills more Americans each year than cocaine and heroin combined.

Pain-management experts advocate for sufficient pain-control measures, but the challenge of opiate addiction and the ability of addicts to crush and snort Rx medications has led to a climate in which patients often have a hard time accessing medicine.

That's where abuse-deterrence comes in. Within the last several months, Biopharma Dive has covered the approval of abuse-deterrent opioids, such as Targiniq ER (naloxone/oxycodone) from Purdue Pharma and Zohydro ER (hydrocodone bitrartate) from Zogenix.

All of these were approved under the old draft guidance.

Going forward new approvals will be reviewed taking the finalized guidance into consideration.






TRUTH

[nsomniyak]

It does not mean anything - simply that they believe they have "trade secrets" that should not be made public in those documents.

[TRUISM]

Obtaining Confidential Treatment for Information Furnished to the SEC
Click For Link

-Excerpt-

company might request confidential treatment only for the name of the other contracting party (if not already publicly known or previously disclosed), the term of the agreement, the exact technology covered and the pricing information (e.g., the royalty rate and any other fees).

TRUTH

[ppl_first]

What does a CTO normally mean for a stock like this, ie is it good news or about to go to zip?

[TRUISM]

Zogenix Files Confidential Treatment Order Today


DEFINITION OF 'CONFIDENTIAL TREATMENT ORDER - CTO'
Click For Investopedia Link


An order that provides confidential treatment for certain documents and information, that a company would otherwise have to file. A confidential treatment order (CTO) is issued by the Securities and Exchange Commission (SEC) and may only be in effect for a certain period of time, rather than indefinitely.


INVESTOPEDIA EXPLAINS 'CONFIDENTIAL TREATMENT ORDER - CTO'


Companies would typically seek a CTO in order to keep information that would otherwise put it at a disadvantage, a secret. For example, a company may apply for such an order to keep information regarding a pricing arrangement made with a partner, secret, since competitors finding out this information may go after the partner with a more competitive price.





TRUTH

[TRUISM]

Short Interest in Zogenix Increases By 6.1% (ZGNX)
Posted on March 30, 2015 by John Miller in Investing, Options Articles
Click For Link





Shares of Zogenix (NASDAQ:ZGNX) were the recipient of a significant growth in short interest during the month of March. As of March 13th, there was short interest totalling 28,195,078 shares, a growth of 6.1% from the February 27th total of 26,561,690 shares, Analyst Ratings Network.com reports. Based on an average daily trading volume, of 8,079,082 shares, the days-to-cover ratio is presently 3.5 days. Approximately 21.1% of the shares of the company are short sold.

A number of research firms have recently commented on ZGNX. Analysts at William Blair downgraded shares of Zogenix from an “outperform” rating to a “market perform” rating in a research note on Wednesday, March 11th. Separately, analysts at Brean Capital reiterated a “buy” rating on shares of Zogenix in a research note on Tuesday, January 20th. One investment analyst has rated the stock with a hold rating and four have assigned a buy rating to the company. The company currently has a consensus rating of “Buy” and a consensus target price of $3.00.

Zogenix (NASDAQ:ZGNX) opened at 1.34 on Monday. Zogenix has a one year low of $1.07 and a one year high of $3.10. The stock’s 50-day moving average is $1. and its 200-day moving average is $1.. The company has a market cap of $205.51 million and a price-to-earnings ratio of 22.33.

Zogenix (NASDAQ:ZGNX) last posted its quarterly earnings results on Tuesday, March 10th. The company reported ($0.13) earnings per share for the quarter, missing the analysts’ consensus estimate of ($0.11) by $0.02. The company had revenue of $14.90 million for the quarter. During the same quarter last year, the company posted ($0.13) earnings per share. Zogenix’s revenue was up 50.5% compared to the same quarter last year. Analysts expect that Zogenix will post $-0.37 EPS for the current fiscal year.






TRUTH

[dave86]

Brokerages Give Average Rating of “Strong Buy” to Zogenix (NASDAQ:ZGNX)
March 29th, 2015 - 0 comments - Filed Under - by Jennifer Langley

Shares of Zogenix (NASDAQ:ZGNX) have been given a consensus broker rating score of 1.40 (Strong Buy) from the five brokers that cover the stock, Zacks Investment Research reports. One research analyst has rated the stock with a hold recommendation and four have given a strong buy recommendation to the company. Zogenix’s rating score has declined by 40% in the last 90 days as a result of a number of analysts’ ratings changes.

Brokerages have set a 1-year consensus target price of $2.75 for the company and are expecting that the company will post ($0.14) EPS for the current quarter, according to Zacks. Zacks has also assigned Zogenix an industry rank of 92 out of 265 based on the ratings given to related companies.

Zogenix (NASDAQ:ZGNX) opened at 1.34 on Thursday. Zogenix has a one year low of $1.07 and a one year high of $3.10. The stock has a 50-day moving average of $1. and a 200-day moving average of $1.. The company has a market cap of $205.51 million and a P/E ratio of 22.33.

Zogenix (NASDAQ:ZGNX) last announced its earnings results on Tuesday, March 10th. The company reported ($0.13) EPS for the quarter, missing the Thomson Reuters consensus estimate of ($0.11) by $0.02. The company had revenue of $14.90 million for the quarter. During the same quarter in the prior year, the company posted ($0.13) earnings per share. The company’s quarterly revenue was up 50.5% on a year-over-year basis. On average, analysts predict that Zogenix will post $-0.37 earnings per share for the current fiscal year.

A number of analysts have recently weighed in on ZGNX shares. Analysts at William Blair downgraded shares of Zogenix from an “outperform” rating to a “market perform” rating in a research note on Wednesday, March 11th. Separately, analysts at Brean Capital reiterated a “buy” rating on shares of Zogenix in a research note on Tuesday, January 20th.

Zogenix, Inc (NASDAQ:ZGNX) 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.

[dave86]

You just have to play the jumps in and out like when it ran to 1.80. This should see 1.50-1.60 again next month after the announce the close of sale for the 100 mil.

[WallStreetopgun]

This stock price has been stuck here for a year plus with never ending empty promises = dead money!

[dave86]

9000 hits the ask then right after we get 100 lot sales so someone is trying to manipulate this.

[RDPHoldings]

Zogenix Announces First Patient Dosed in Relday Multi-Dose Clinical Study

http://money.cnn.com/news/newsfeeds/articles/globenewswire/10126427.htm

Results Anticipated in Third Quarter 2015, Positioning Zogenix for Potential World-Wide Partnering Opportunities for Relday
March 26, 2015: 09:00 AM ET

SAN DIEGO, March 26, 2015 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that dosing has begun in patients enrolled in its Relday™ multi-dose Phase 1b clinical study. Relday is a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated for the treatment of schizophrenia.
Relday has been designed to provide potentially significant improvements over current long-acting injection treatment options for patients suffering from schizophrenia. In a Phase 1 single-dose clinical study in schizophrenic patients, Relday demonstrated the ability to achieve therapeutic plasma levels of risperidone on the first day of dosing, followed by a controlled release profile over the remaining four-week period. This pharmacokinetic profile of Relday may eliminate the requirement for long-acting risperidone injections to be supplemented with daily oral therapy for several weeks during therapy initiation or when patients are not fully compliant with an injection regimen over the course of long-term therapy. In addition, dose-proportionality for Relday has been established across all doses, as well as the duration of treatment being consistent with once-monthly dosing. Unlike all currently marketed long-acting injectable treatment options which are administered via intramuscular injection, Relday is administered subcutaneously. Moreover, unlike some leading injectable products in the category, Relday does not require reconstitution prior to use.
Fifty-six subjects with schizophrenia or schizoaffective disorder are planned to be enrolled in this open label, multi-dose, safety and pharmacokinetic (PK) study. Subjects will be administered Relday or Risperdal® Consta® (risperidone), an approved long-acting intramuscular injectable with the same active ingredient as Relday. Patients being administered Risperdal Consta will also receive daily oral risperidone supplementation during a three-week initiation period, and will be dosed every two weeks, as required by its prescribing label. Subjects will be followed for up to 20 weeks in order to confirm and compare the time to reach drug concentrations within the therapeutic range and to compare steady state pharmacokinetics for Relday and Risperdal Consta. The Company anticipates that results from the Relday multi-dose study will be available in the third quarter of 2015.
The Company also plans to initiate efforts to secure an ex-U.S. strategic development and commercialization partner for Relday during this development stage and is targeting an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by early 2016. If completed, these milestones would position the Company to begin a Phase 3 clinical study for Relday in 2016.
Brad Galer, M.D., chief medical officer of Zogenix, stated, "We are pleased to move the Relday development program forward into this next clinical study. We expect the data to continue to demonstrate that Relday's novel formulation has a differentiated product profile amongst currently marketed long-acting injections for the treatment of schizophrenia that should enhance the treatment for this patient population."
In July 2011, Zogenix licensed from DURECT (Nasdaq:DRRX) exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.
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: delivery and dosing benefits of Relday and the potential to demonstrate that Relday has a differentiated product profile amongst currently marketed long-acting injections; timing for the availability of results from the Phase 1b clinical trial, an end-of-Phase 2 meeting with the FDA, and the initiation of a Phase 3 clinical trial for Relday; and the initiation of efforts to secure potential partners for rest-of-world development and commercialization of Relday. 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 risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as Relday, including potential delays in enrollment and completion of clinical trials; competition from other pharmaceutical or biotechnology companies; inadequate therapeutic efficacy or unexpected adverse side effects relating to Relday that could prevent its development or commercialization; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; the terms of any development or commercialization partnership for Relday may not be favorable, and the partner may not perform as expected; the market potential for anti-psychotics, and Zogenix's ability to compete within that market; Zogenix's ability to obtain, and the validity and duration of, patent protection and other intellectual property rights for Relday; and other risks described in Zogenix's prior press releases as well as in public periodic 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 press 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.
Relday™ is a trademark of Zogenix, Inc.
SABER® is a registered trademark of DURECT Corporation.
Risperdal® Consta® is a registered trademark of Janssen Pharmaceuticals, Inc.
CONTACT: Investors
Zack Kubow, The Ruth Group
646.536.7020, [e-mail]
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[2014shelby]

Thanks for the info; hopefully ZGNX can rebound

[RDPHoldings]

Hedge Funds - News

http://www.insidermonkey.com/blog/broadfin-buffs-up-on-zogenix-inc-zgnx-and-derma-sciences-inc-dsci-340666/

[paladin551]

[url][/url][tag]http://seekingalpha.com/article/3007296-market-oversells-zogenix-after-company-exits-pain-business[/tag]



Market Oversells Zogenix After Company Exits Pain Business
Mar. 17, 2015 12:30 PM ET | 2 comments | About: Zogenix, Inc.
Summary

Shares tanked 27% after Q4 report and Zohydro sale/personnel transfer, to bring the market cap to below $200M.
However, after the transaction, Zogenix is now flush with >$100M cash and is stable til the end of 2016. And with Zogenix, another M&A is never out of the picture.
The remaining pipeline consist of two advanced-stage potential blockbusters, which are definitely worth more than the balance of the market cap.

Zogenix (NASDAQ:ZGNX) is a small specialty pharmaceutical company developing therapies that address central nervous system (NYSE:CNS) conditions. It has a market cap of $199.37 million and on March 10, reported financial results for the fourth quarter ended December 31, 2014. On the same day, Zogenix announced the sale of its Zohydro ER (extended-release hydrocodone) business, including the transfer of the Zogenix pain sales team, to Pernix Therapeutics (NASDAQ:PTX) for $100 million plus milestones up to $283.5 million. The transaction transformed Zogenix to a cash-laden company with a late-stage CNS pipeline. Zogenix can also decide to go shopping, like it did when it acquired Brabant Pharma in October to obtain their Brabafen (now ZX008).
Remaining lead candidates compare favorably to other big sellers.

ZX008 (low-dose fenfluramine) and Relday (once-monthly subcutaneous risperidone) are Phase 3-ready product candidates. Fenfluramine (Pondimin) was half of the notorious "fen-phen," a widely used off-label combination with phentermine for long-term management of obesity in the 1990s. Pondimin and the related drug Redux (dexfenfluramine) were both withdrawn from the market in 1997 after causing heart valve disease in an unacceptably high number of patients. Over 30% of patients developed valvulopathy on a daily Pondimin dose of at least 20 mg/day. Pondimin had been on the market for more than 20 years before the problem became widely known.

ZX008 has orphan drug designation in the U.S. and Europe for the treatment of Dravet syndrome. It is estimated that 1 in 20,000-40,000 children have this genetic disorder of the brain. The potential to reduce the frequency of serious seizures (childhood mortality >15%) and the accompanying complications (infections, developmental disability) may heavily outweigh the cardiac risks of fenfluramine use.

Small fenfluramine dosages in the range of 0.12-0.90 mg/kg/day were effective in children 1-16 years of age. Anecdotally, researches told of kids who developed the feared heart valve thickening, but whose parents refused to stop treatment. Seventy percent of the children remained seizure-free for more than a year. If even half of this efficacy is confirmed by the Phase 3, it would still be superior to any treatment regimen reported in literature. While it is premature to speculate on pricing, the orphan drug status suggests that ZX008 is a future blockbuster when compared to, say, products from BioMarin (NASDAQ:BMRN) that are netting $200-300 million annually from much rarer diseases. Zogenix's remaining personnel should easily be able to cover the few Dravet syndrome experts per territory.

[micromillionaire]

Reading you latest post today.... Where did you receive that info?

[Bob Stocks]

Relday, it's a once a month injection antipsychotic...many people bought ZGNX just for this drug...data in Q3...Suppose to be a billion dollar drug

[nsomniyak]

So, Bob, what exactly is left here after selling off Zohydro?

[TRUISM]

No argument there.




TRUTH

[Bob Stocks]

Look at ALKS...that one skyrocketed after their positive results of their antipsychotic drug. Relay is comparable

[TRUISM]

Based on the Phase 1 clinical trial results:

Based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the current study to include a 100 mg dose of the same formulation

Click For Zogenix PR


You may be onto something.




TRUTH

[Bob Stocks]

Anticipation of results should send it to over $2.00

[TRUISM]

Time to buy imo...Zohydro gone

I couldn't agree with you more....

It appears that we've seen the bottom.

Relday results in Q3....

With encouraging results,look for this stock to have legs.

If approved, Relday will be the first subcutaneous, needle-free antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic profile, significant reduction in injection volume and a simplified dosing regimen due to DURECT's SABER controlled-release formulation technology in combination with Zogenix's DosePro needle-free subcutaneous drug delivery system.

Roger L. Hawley, chief executive officer of Zogenix, said, "We are encouraged by Relday's potential of improving patient compliance due to the safety and convenience provided by DosePro's needle-free delivery system combined with a long-acting formulation of an established antipsychotic. Our market research indicates that psychiatrists prefer a subcutaneous, needle-free, once-monthly treatment option over products that are currently available."

Click For Previous Zogenix News






TRUTH

[Bob Stocks]

Time to buy imo...Relday results in Q3....Zohydro gone, no big deal

[TRUISM]

What happen here?

THIS:

Zogenix To Sell Painkiller Business To Pernix Therapeutics*
BY NATALIE GROVER--Tue Mar 10, 2015 8:20pm EDT
Click For reuters.com PR


(Reuters) - Zogenix Inc (ZGNX.O) said on Tuesday it would sell its Zohydro business to Pernix Therapeutics Holdings Inc (PTX.O) in a deal that could be worth nearly $400 million, to cut costs and focus on two other drugs in its pipeline.

The deal was not expected, but it is not surprising, Oppenheimer & Co's Akiva Felt said in an interview, as Zogenix was feeling the heat of marketing its sole, controversial, drug on the market, and the company never really recovered from the negative press that accompanied the launch of the drug.

"They had to spend a lot of money selling a drug that was growing slowly under their launch; they couldn't afford to do that indefinitely."

Zohydro belongs to the opioid class of drugs, which includes not just powerful prescription painkillers, but also heroin. Since its launch in March 2014, more than 57,000 prescriptions have been written.

The active ingredient of the extended-release painkiller, hydrocodone, is the most commonly prescribed opioid in the United States. Zohydro had drawn widespread criticism as the United States grapples with a surge in opioid abuse.

The deal gives Pernix three extended release hydrocodone products, including an abuse-deterrent version and licenses to multiple patents designed to protect the franchise through 2030.

Zogenix, in turn, will receive a $100 million upfront payment and as much as $283.5 million in milestone payments, it said on Tuesday.

Zogenix Chief Executive Roger Hawley, in a conference call with analysts, said he did not want to reach the point of being forced to raise money, going forward, having dealt with a financial overhang long enough.

"One of the key reasons we made this difficult choice with Zohydro was to be in control of our own destiny"

Zogenix's stock was down about 10 percent in extended trade.

As part of the deal, expected to close in April, Zogenix will also transfer its sales team and other select employees to Pernix, reducing its employee count to 60 from 200.

The deal gives Zogenix capital to develop its remaining assets: brabafen, to treat Dravet syndrome, and relday, to fight schizophrenia. Zohydro will complement Pernix's existing central nervous system product line, while adding extra hands to its sales force.

Leerink Partners LLC acted as financial adviser and Latham & Watkins LLP acted as legal adviser to Zogenix. Jefferies LLC acted as financial adviser to Pernix, whose legal advisers were Lowenstein Sandler LLP and Goodwin Procter LLP.

At the end of January, the U.S. Food and Drug Administration approved an abuse-deterrent version of Zohydro.

TRUTH

[Shotor]

Welcome to the world of corruption, pump n dump, illusion, .... This stock will be delisted soon