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Zohydro

Type: Product

Name: Zohydro

First reported May 21 2013 - Updated May 21 2013 - 1 reports

FDA Food & Drug Administration

2013 FDA Drug Approval Calendar

BOSTON (TheStreet) -- Gilead Sciences (GILD) and Amarin (AMRN) highlight the updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected for the remainder of 2013.The next era of hepatitis C therapy could begin on Dec. ... [Published Oncology Business Review - May 21 2013]

Entities: FDA Food & Drug Administration, Drugs, Ibrutinib, AVEO Pharmaceuticals Inc, Amarin Corporation Plc

First reported May 10 2013 - Updated May 10 2013 - 1 reports

Amarin Corporation Plc

Biotech Stock Mailbag: Synta, Zogenix, Sarepta, Amarin

BOSTON (TheStreet) -- This week's Biotech Stock Mailbag is open for business. @adamfeuerstein SNTA getting hit hard, do you suspect SNTA to respond with a PR/Statement of some sort?Bit hard to ignore, I would think? Bill H. (@bheafey) May 8, 2013Synta ... [Published TheStreet.com - May 10 2013]

Entities: Ganetespib, Amarin Corporation Plc, Zogenix Inc

First reported May 09 2013 - Updated May 10 2013 - 2 reports

Zogenix's CEO Discusses Q1 2013 Results - Earnings Call Transcript

4:30 PM ETOperatorGood day, ladies and gentlemen and welcome to the Q1 2013 Zogenix Inc Earnings Conference Call. My name is Catherine and I will be your operator for today. At this time, all participants are in listen-only mode, we will conduct a question-and-answer ... [Published Seeking Alpha - May 10 2013]

Entities: Zohydro, Zogenix Inc, Relday, New Drug Application, Vicodin

First reported May 09 2013 - Updated May 09 2013 - 1 reports

Zogenix Earnings: Here’s Why Investors are Selling Shares Now

Zogenix, Inc. ( NASDAQ:ZGNX ) had a loss and missed Wall Street’s expectations, AND came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are down 2.41%.Markets ... [Published Wall St. Cheat Sheet - May 09 2013]

Entities: Zogenix Inc, Zohydro, Stocks, Xignite Financials, Earnings Per Share

First reported May 02 2013 - Updated May 02 2013 - 1 reports

Zogenix Inc

Zogenix Poised For 40% Haircut As Zohydro Decision Approaches

By Jake King and Rajesh Patel, Ph.D.Zogenix (ZGNX) currently awaits an approval decision from the FDA on Zohydro ER (extended release), a hydrocodone bitartrate formulation that differs from existing hydrocodone products because it does not include acetaminophen ... [Published Seeking Alpha - May 02 2013]

Entities: Zohydro, Zogenix Inc, Vicodin, OxyContin

First reported Apr 30 2013 - Updated Apr 30 2013 - 1 reports

Zohydro - Is There Enough Upside For Zogenix?

By Alpha Cardinal : By Jordan Plews, Ph.D.; T. Bacaj, Ph.D.; and Paul Nash, Ph.D. Zogenix is a pharmaceutical company specializing in the commercialization and development of products for the treatment of central nervous system (CNS) disorders and ... [Published Healthcare Sector and Stocks Analysis from Seek ... - Apr 30 2013]

Entities: Zohydro, Zogenix Inc, Doctor of Philosophy, Vicodin, opioid

First reported Apr 18 2013 - Updated Apr 18 2013 - 1 reports

Decision A Boon for Abuse-Resistant Pills

Acura Pharmaceuticals Inc. benefited greatly from a decision by federal regulators to block new painkillers that aren't designed to resist abuse.Acura makes drugs that are designed to be harder to abuse. The company sells a decongestant called Nexafed ... [Published Drug Discovery and Development - Apr 18 2013]

Entities: Drugs, Zohydro, OxyContin, anodyne

First reported Apr 17 2013 - Updated Apr 17 2013 - 1 reports

Acura Pharma rises on FDA OxyContin decision

NEW YORK -- Shares of drug developer Acura Pharmaceuticals Inc. jumped more than 50 percent Wednesday after federal regulators moved to block new painkillers that aren't designed to resist abuse.Acura makes drugs that are designed to be harder to abuse. ... [Published CNBC - Apr 17 2013]

Entities: OxyContin, Acura Pharmaceuticals Inc, FDA Food & Drug Administration, Drugs

First reported Apr 17 2013 - Updated Apr 17 2013 - 1 reports

Leerink Swann Remains Positive on Zogenix (ZGNX)

Shares of Zogenix, Inc. (Nasdaq: ZGNX) opened lower on Wednesday following news late on Tuesday that the FDA would disallow marketing of generics old formulation Oxycontin due to safety concerns.Commenting on news, analyst Michael Schmidt of Leerink Swann ... [Published Street Insider - Apr 17 2013]

Entities: Zogenix Inc, Leerink Swann & Co Inc, Michael Schmidt, Zohydro

First reported Apr 04 2013 - Updated Apr 04 2013 - 1 reports

Why Zohydro May Or May Not Be Approved

ByAbraham David: With a big FDA decision expected to surprise investors in Zogenix ( ZGNX ) any day now, it is important to take into consideration all arguments for and against this company. When the decision is announced there will be no going back, ... [Published Healthcare Sector and Stocks Analysis from Seek ... - Apr 04 2013]

Entities: Zohydro, Zogenix Inc, Drugs, Business Strategy, Environment

First reported Mar 15 2013 - Updated Mar 15 2013 - 1 reports

Zogenix Earnings: Here’s Why the Stock is Rising Now

Zogenix, Inc. ( NASDAQ:ZGNX ) had a loss and beat Wall Street’s expectations, BUT came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are up 4.53%. Markets ... [Published Wall St. Cheat Sheet - Mar 15 2013]

Entities: Zogenix Inc, Zohydro, Mallinckrodt Inc, Vicodin, Paracetamol

First reported Dec 14 2012 - Updated Dec 15 2012 - 2 reports

Is Zogenix A Buy After FDA Panel Says 'No' To Zohydro?

ByC.R. Jackson: Zogenix Inc. , ( ZGNX ) is the first pharmaceutical company to face a U.S. Food and Drug Administration (FDA) panel seeking approval for pure hydrocodone , a painkilling drug that can be 10 times stronger than Vicodin . Hydrocodone ... [Published Healthcare Sector and Stocks Analysis from Seek ... - Dec 14 2012]

Entities: Zogenix Inc, Vicodin, Zohydro

Quotes

Roger Hawley, chief executive officer of Zogenix, stated, "We recently had an update call with the FDA regarding the status of the Zohydro ER new drug application NDA). On the call, the FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, we have concluded the FDA are working on several broader opioid-related issues that need to be addressed prior to an action on our NDA. We were not informed of any deficiencies in the application, which suggests that the remaining steps in the review process are finalizing the Zohydro ER REMS, to be consistent with the updated class-wide REMS, and labeling discussions. We are disappointed with the ongoing delay, and remain prepared to launch the product three to four months after potential approval."

Zogenix Reports First Quarter 2013 Financial Results [Published Stockwatch - May 09 2013]

...now confirmed the product candidate's viability across the anticipated commercial dosing range," said Stephen Farr, Ph D , president of Zogenix. "We are well positioned to begin a multi-dose clinical trial to provide steady-state pharmacokinetic and safety data, once a partner is secured, prior to initiating Phase 3 development studies."

Zogenix Reports Positive Top-Line Results From Extended Reld. . . [Published Equities.com - May 02 2013]

"We believe ZGNX shares are already pricing in the worst case scenario. Thus, we believe FDA approval would be a significant positive surprise, and even a CRL calling for modification to the proposed REMS program would also be a positive for ZGNX shares, in our view" said Schmidt

Leerink Swann Remains Positive on Zogenix (ZGNX) [Published Street Insider - Apr 17 2013]

John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, commented, "In the three years since its launch, we have produced more than 2 million commercial units of our first commercial DosePro product, SUMAVEL® DosePro®. The introduction of a needle-free delivery option has reinvigorated growth of injectable sumatriptan, including from patients that were previously not interested due to needle-phobia and/or the complexity of delivery. We are pleased to provide an enhanced needle-free option for these patients and look forward to continue working with Battelle to introduce the benefits of the DosePro system to potential partners in the biopharmaceutical and government sectors."

Zogenix and Battelle Extend DosePro Co-Marketing Partnership [Published Stockwatch - Mar 27 2013]

More Content

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2013 FDA Drug Approval Calendar [Published Oncology Business Review - May 21 2013]
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Biotech Stock Mailbag: Synta, Zogenix, Sarepta,... [Published TheStreet.com - May 10 2013]
Zogenix's CEO Discusses Q1 2013 Results - Earni... [Published Seeking Alpha - May 10 2013]
Zogenix Earnings: Here’s Why Investors are Sell... [Published Wall St. Cheat Sheet - May 09 2013]
Zogenix Earnings: Here’s Why Investors are Sell... [Published Wall St. Cheat Sheet - May 09 2013]
Zogenix Reports First Quarter 2013 Financial Re... [Published Stockwatch - May 09 2013]
Manufacturers Under Pressure to Manage Painkillers [Published Pharmaceutical Executive - May 06 2013]
Zogenix Poised For 40% Haircut As Zohydro Decis... [Published Seeking Alpha - May 02 2013]
Zogenix Reports Positive Top-Line Results From ... [Published Equities.com - May 02 2013]
Zogenix Reports Positive Top-Line Results From ... [Published Street Insider - May 02 2013]
Zohydro - Is There Enough Upside For Zogenix? [Published Healthcare Sector and Stocks Analysis from Seek ... - Apr 30 2013]
Decision A Boon for Abuse-Resistant Pills [Published Drug Discovery and Development - Apr 18 2013]
Acura Pharma rises on FDA OxyContin decision [Published CNBC - Apr 17 2013]
Leerink Swann Remains Positive on Zogenix (ZGNX) [Published Street Insider - Apr 17 2013]
Why Zohydro May Or May Not Be Approved [Published Healthcare Sector and Stocks Analysis from Seek ... - Apr 04 2013]
Zogenix and Battelle Extend DosePro Co-Marketin... [Published Stockwatch - Mar 27 2013]
Zogenix Earnings: Here’s Why the Stock is Risin... [Published Wall St. Cheat Sheet - Mar 15 2013]
4 Healthcare Stock Stories to Keep Investors Well [Published Wall St. Cheat Sheet - Feb 27 2013]
US EQUITIES OPENING HEADLINES INCLUDING: Exxon ... [Published Proactiveinvestors United Kingdom RSS feed - Feb 27 2013]
Zogenix Provides Update on Zohydro(TM) ER Regul... [Published GlobeNewswire: Acquisitions News - Feb 27 2013]
Infinata’s BioPharm Insight Releases its Cataly... [Published PRWeb - Feb 26 2013]
Is Zogenix A Buy After FDA Panel Says 'No' To Z... [Published Healthcare Sector and Stocks Analysis from Seek ... - Dec 14 2012]
FDA Advisory Meeting Leaves Zogenix Stock In Ta... [Published Healthcare Sector and Stocks Analysis from Seek ... - Dec 14 2012]
Apple Analyst Sees $800 Ahead and 2 Stock Insig... [Published Wall St. Cheat Sheet - Dec 10 2012]
Zogenix Provides Update on FDA Advisory Committ... [Published GlobeNewswire: Advertising News - Dec 07 2012]
Important Catalysts For 3 Biotech Companies [Published Healthcare Sector and Stocks Analysis from Seek ... - Dec 07 2012]
FDA Panel to Review Opioid [Published MedPageToday.com - medical news plus CME for ph ... - Dec 06 2012]
Jet Life Penny Stocks Newsletter Announces Aler... [Published PRWeb - Oct 04 2012]

Blogs

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Zogenix Earnings: Here’s Why Investors are Sell... [Published Wall St. Cheat Sheet - May 09 2013] Zogenix, Inc. ( NASDAQ:ZGNX ) had a loss and missed Wall Street’s expectations, AND came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are down 2.41%.Markets ...
Zogenix Earnings: Here’s Why Investors are Sell... [Published Wall St. Cheat Sheet - May 09 2013] Zogenix, Inc. ( NASDAQ:ZGNX ) had a loss and missed Wall Street’s expectations, AND came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are down 2.41%. ...
Zogenix Earnings: Here’s Why the Stock is Risin... [Published Wall St. Cheat Sheet - Mar 15 2013] Zogenix, Inc. ( NASDAQ:ZGNX ) had a loss and beat Wall Street’s expectations, BUT came up short on beating the revenue expectation. The revenue miss is a negative sign to shareholders seeking high growth out of the company. Shares are up 4.53%. Markets ...
4 Healthcare Stock Stories to Keep Investors Well [Published Wall St. Cheat Sheet - Feb 27 2013] Accretive Health ( NYSE:AH ) Current price $9.40 The firm said Tuesday it will delay posting its financial results for the fourth quarter and full year 2012, along with its previously announced investor conference call set for February 27th, because ...
Apple Analyst Sees $800 Ahead and 2 Stock Insig... [Published Wall St. Cheat Sheet - Dec 10 2012] Apple Inc. ( NASDAQ:AAPL ): Jefferies expects Apple Inc.’s growth to slow down and margin leverage to be negative in fiscal year 2014. The firm lowered their price target for shares from $900 to $800, but believe that Apple will post solid first and ...

Press Releases

sort by: Date \| Relevance
Zogenix Provides Update on Zohydro(TM) ER Regul... [Published GlobeNewswire: Acquisitions News - Feb 27 2013]
Zogenix Provides Update on FDA Advisory Committ... [Published GlobeNewswire: Advertising News - Dec 07 2012]