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Just watching on "60 Minutes" about Fluvoximine Maleate pills used on people who got Covid. Those who took this pills recovered without going to the hospital. Interesting considering the pills was for Obsessive Compulsive Disorder.
BREAKING NEWS: $JAZZ Jazz Pharmaceuticals Announces Positive Top-line Results from Phase 3 Study of Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Adult Patients with Idiopathic Hypersomnia
Jazz Pharmaceuticals Announces Positive Top-line Results from Phase 3 Study of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Adult Patients with Idiopathic Hypersomnia Clinically meaningful and highly statistically significant results for pr...
News: $JAZZ Jazz Pharmaceuticals Data to Showcase Ongoing Sleep Medicine Research at SLEEP 2019
DUBLIN , May 9, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that 14 abstracts sponsored by Jazz Pharmaceuticals and one abstract from an investigator-sponsored trial will be presented at the 33 rd Annual Meeting of the Associated Professional Sleep S...
Support level hit today...let's see if it holds....wouldn't mind seeing it driven a little lower, too smooth means boring & unplayable for any worthy profit....
*DJ Jazz Pharmaceuticals: Phase 1 Clinical Data Generated To Date Supports Completing The Phase 1 Evaluation Of Jzp-386 At The Originally Planned Highest Dose
Last update: 09/12/2014 8:31:26 am
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
December 09, 2014 08:31 ET (13:31 GMT)
Copyright (c) 2014 Dow Jones & Company, Inc.
Jazz Pharma, Concert Pharma Report JZP-386 Program Update
Last update: 09/12/2014 8:30:50 am Jazz Pharmaceuticals plc (NASDAQ: JAZZ) and Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue. The existing Phase 1 clinical data was generated in a first-in-human trial evaluating the safety, pharmacokinetics, and pharmacodynamics of JZP-386; enrollment was completed in the third quarter. A second Phase 1 trial evaluating JZP-386 at the originally planned highest dose is expected to be initiated in the first quarter of 2015, with data expected in the second quarter of 2015.
JZP-386 is a deuterium-containing analog of sodium oxybate. The Phase 1 program is comparing JZP-386 to sodium oxybate versus placebo in healthy volunteers. The companies expect that the results from the upcoming Phase 1 trial will inform the next steps in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem, a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, a serious neurological disorder that affects approximately 1 in 2000 people in the United States.
Jazz Pharmaceuticals and Concert Pharmaceuticals Provide JZP-386 Program Update
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue. The existing Phase 1 clinical data was generated in a first-in-human trial evaluating the safety, pharmacokinetics, and pharmacodynamics of JZP-386; enrollment was completed in the third quarter. A second Phase 1 trial evaluating JZP-386 at the originally planned highest dose is expected to be initiated in the first quarter of 2015, with data expected in the second quarter of 2015.
JZP-386 is a deuterium-containing analog of sodium oxybate. The Phase 1 program is comparing JZP-386 to sodium oxybate versus placebo in healthy volunteers. The companies expect that the results from the upcoming Phase 1 trial will inform the next steps in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem(R), a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, a serious neurological disorder that affects approximately 1 in 2000 people in the United States.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing differentiated products that address unmet medical needs. The company has a diverse portfolio of products and/or product candidates in the areas of sleep, hematology/oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem(R) (sodium oxybate) oral solution, Erwinaze(R) (asparaginase Erwinia chrysanthemi), Prialt(R) (ziconotide) intrathecal infusion, Versacloz(R) (clozapine) oral suspension, FazaClo(R) (clozapine, USP) HD and FazaClo LD. Jazz Pharmaceuticals also has a number of products marketed outside the United States, including Erwinase(R) and Defitelio(R) (defibrotide). For more information, please visit www.jazzpharmaceuticals.com.
About Concert Pharmaceuticals
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform(R) (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The Company is developing a broad pipeline targeting CNS disorders, renal disease, inflammation and cancer. For more information, please visit www.concertpharma.com.
About Xyrem
Xyrem(R) (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of EDS in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem Success Program(R). Xyrem was first approved in the United States in 2002. Safety and effectiveness in pediatric patients have not been established.
IMPORTANT SAFETY INFORMATION ------------------------------------------------------------------------------ XYREM is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in XYREM-treated patients. Almost all of the patients who received XYREM during clinical trials in narcolepsy were receiving CNS stimulants. XYREM is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, XYREM is available only through a restricted distribution program called the XYREM Success Program(R), using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88(R) (1-866-997-3688).
Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Use caution when considering the concurrent use of Xyrem with other CNS depressants. Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. Xyrem is a Schedule III controlled substance. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Monitor patients for emergent or increased depression and suicidality and for impaired motor/cognitive function. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Consider the amount of daily sodium intake in each dose of Xyrem in patients sensitive to salt intake.
Jazz Pharmaceuticals plc "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to future events in the Phase 1 clinical program for JZP-386, the timing of the second Phase 1 clinical trial, the therapeutic potential of JZP-386 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the timing and conduct of clinical trials and the therapeutic value of JZP-386; the uncertainty of regulatory approval; and those risks with respect to research and development and clinical trials detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, and future filings and reports by Jazz Pharmaceuticals. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
Concert Pharmaceuticals Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the future clinical development of JZP-386, the potential effectiveness of JZP-386, our plans and timelines for the clinical development of JZP-386 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the " Risk Factors" section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.
Jazz Pharmaceuticals and the Jazz Pharmaceuticals logo are registered trademarks of Jazz Pharmaceuticals plc or its subsidiaries.
Jazz Pharmaceuticals plc (NASDAQ:JAZZ) and Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue. The existing Phase 1 clinical data was generated in a first-in-human trial evaluating the safety, pharmacokinetics, and pharmacodynamics of JZP-386; enrollment was completed in the third quarter. A second Phase 1 trial evaluating JZP-386 at the originally planned highest dose is expected to be initiated in the first quarter of 2015, with data expected in the second quarter of 2015.
JZP-386 is a deuterium-containing analog of sodium oxybate. The Phase 1 program is comparing JZP-386 to sodium oxybate versus placebo in healthy volunteers. The companies expect that the results from the upcoming Phase 1 trial will inform the next steps in the development program for JZP-386.
Sodium oxybate is the active ingredient in Xyrem(R), a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, a serious neurological disorder that affects approximately 1 in 2000 people in the United States.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing differentiated products that address unmet medical needs. The company has a diverse portfolio of products and/or product candidates in the areas of sleep, hematology/oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem(R) (sodium oxybate) oral solution, Erwinaze(R) (asparaginase Erwinia chrysanthemi), Prialt(R) (ziconotide) intrathecal infusion, Versacloz(R) (clozapine) oral suspension, FazaClo(R) (clozapine, USP) HD and FazaClo LD. Jazz Pharmaceuticals also has a number of products marketed outside the United States, including Erwinase(R) and Defitelio(R) (defibrotide). For more information, please visit www.jazzpharmaceuticals.com.
About Concert Pharmaceuticals
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform(R) (deuterated chemical entity platform) to create novel small molecule drugs. This approach starts with approved drugs, advanced clinical candidates or previously studied compounds that have the potential to be improved with deuterium substitution to enhance clinical safety, tolerability and efficacy. The Company is developing a broad pipeline targeting CNS disorders, renal disease, inflammation and cancer. For more information, please visit www.concertpharma.com.
About Xyrem
Xyrem(R) (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of EDS in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem Success Program(R). Xyrem was first approved in the United States in 2002. Safety and effectiveness in pediatric patients have not been established.
IMPORTANT SAFETY INFORMATION ------------------------------------------------------------------------------ XYREM is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in XYREM-treated patients. Almost all of the patients who received XYREM during clinical trials in narcolepsy were receiving CNS stimulants. XYREM is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. Because of the risks of CNS depression, abuse, and misuse, XYREM is available only through a restricted distribution program called the XYREM Success Program(R), using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88(R) (1-866-997-3688).
Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency. Use caution when considering the concurrent use of Xyrem with other CNS depressants. Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. Xyrem is a Schedule III controlled substance. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Monitor patients for emergent or increased depression and suicidality and for impaired motor/cognitive function. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Consider the amount of daily sodium intake in each dose of Xyrem in patients sensitive to salt intake.
Jazz Pharmaceuticals plc "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to future events in the Phase 1 clinical program for JZP-386, the timing of the second Phase 1 clinical trial, the therapeutic potential of JZP-386 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the timing and conduct of clinical trials and the therapeutic value of JZP-386; the uncertainty of regulatory approval; and those risks with respect to research and development and clinical trials detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, and future filings and reports by Jazz Pharmaceuticals. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
Concert Pharmaceuticals Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about the future clinical development of JZP-386, the potential effectiveness of JZP-386, our plans and timelines for the clinical development of JZP-386 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals and other factors discussed in the " Risk Factors" section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.
Jazz Pharmaceuticals and the Jazz Pharmaceuticals logo are registered trademarks of Jazz Pharmaceuticals plc or its subsidiaries.
lolzzz, I really did use it a lot too....great system.... Yes, JAZZ has been very good to me....Been in and out since it was on the $1 menu back in '09 when I signed up on IHUB. Kept reloading on dips when I would trip out...
Wish I would have put 20k into it instead of 5k but it was a longshot back then...shouldof, couldof, wouldof....lolzzzzzz
Have a great weekend Skitradr...
Marked ya....I had GE too back then...Got it when OBama got in office...Illinois connection there...knew that would pay off ok...lol....
That's funny.......just found one of you're old post from way back in feb 2011....... Talking about the cup and saucer......wow....looks like you have had an incredible ride...
Buy point at $165+....nice..... dammmm, I haven't done a line look at for a while....have found some nice gainers off the old cup and saucer....nice reminder too....lol...
I agree.....picked up some sept 20th $ 165.00 calls @ $ 3.11 this morning.......news should hit this weekend about possible buy out .....hoping for nice gap up Monday .....
AMBS is a Sham... Look at the BS leadership, the dilution, etc. Completely different type of biotech. One is real, the other is not... Been in and out of jazz for years and wish I had just stayed...
LOLZZZZZZ....Not sure who is still around....I loaded up as a lotto play in '09 as you could buy all you wanted for under a dolla ... I let the load ride up to the drop off after mid $170's as it hit a stop trigger I had set. Truly just a friggin' monsta lotto as nothing stopped it....Any short action was quickly taken out. The smart ones just stayed away after the initial burning of their postions....lol...
First low resistance was low $120's so I put a portion of the BankLoad back in on the second dip in May and will ride this as I am playing just technicals on this now since I have no time for DD on it but haven't heard anything negatives. Could be hitting it's top....A forward split would be a nice reward for the longs though and that would get it moving again I would bet, .... RSI still has a ton of head room after the cool off and MFI looks like more is flowing into this beast....Could see $200 before it hits the high water mark again....
Ya never retire from da game
Found it while I was playing GNTA (Genta) as that was channeling nicely for over a year...nice ATM there back then...lol....
I have 2 little ones so I let my IHub script run out last year and am just trying to get back into swing here again....A sell trigger going off on Jazz will do that to one...
Just checked out the board after I ran across this old post of mine....I have to be premium again to do searches, even on my own posts....lol...
Just curious. I am from another board (almost embarrassed to mention due to the clowns that post nonsense constantly, ie AMBS) as was wondering if there were any here who had rode this thing all the way up? Are those people still posting, or have they long since retired and have distanced themselves from the market? Just curious who would be left posting here on this board after such a huge run.
Jazz Pharmaceuticals plc is a dynamic specialty biopharmaceutical company that identifies, develops and commercializes innovative products to address unmet medical needs in focused therapeutic areas, always keeping in mind our mission to improve patients' lives. Living our core values of integrity, passion, collaboration, innovation and the pursuit of excellence is the key to our success.
MISSION & VALUES
MISSION
Our mission is to improve patients' lives by identifying, developing and commercializing important specialty pharmaceutical products to address unmet patient needs. We address serious diseases, always with the goal of improving patient care. Keeping patients at the forefront of our mind inspires us to bring innovative and valuable resources to all aspects of our business for the ultimate benefit of the patients in need.
CORE VALUES
Our core values define our corporate practices and demonstrate our commitment to improving patients' lives.
INTEGRITY
We value honesty and compliance with all of the laws, rules, regulations and corporate policies that apply to our business, and we expect the same total commitment from our employees, consultants, business partners and service providers. We view our uncompromising commitment to honesty and compliance as a core value - one that we look for in all of our employees.
COLLABORATION
Like the talented musicians who inspired our company name, we believe that the whole is much greater than the sum of its parts. Jazz musicians are known for working together to create new and exciting riffs or new variations on familiar themes. Similarly, the hallmark of our collaborative spirit is our ability to work together in creative teams to accomplish not only research and development goals, but also commercial and corporate objectives. Our value of and respect for one another support our collaboration on projects to help patients, patient advocates and our community.
PASSION
Our passion is our unwavering commitment to improving patient care. The intensity we devote to our efforts and our focus on the efficient development of products to address unmet patient needs are clear evidence of our passion.
INNOVATION
Innovation is essential to help patients and health care providers address unmet medical needs. Striving to provide new benefits for unmet patient needs requires us to look for novel solutions, particularly where others have been discouraged by the difficulty of the problem or the small size of the patient population.
PURSUIT OF EXCELLENCE
In all that we do - our passion and collaboration, our integrity and our caring for patients - we demonstrate our pursuit of excellence. We will always strive to take it to the next level.
WHAT'S IN A NAME?
The name "Jazz Pharmaceuticals" was inspired by the talented jazz musicians who come together - each a musical specialist with an individual style - to make music in concert that is greater than the sum of its parts. Jazz musicians are known for working together to create new and exciting riffs or new variations on familiar themes. Jazz music showcases the coexistence of improvisation and structure.
At Jazz Pharmaceuticals, we believe that each member of our team makes integral contributions working toward a common goal to improve patients' lives. The hallmark of our collaborative spirit is our ability to work together in creative teams to accomplish not only research and development goals, but also commercial and corporate objectives.
PRODUCTS
At Jazz Pharmaceuticals, our mission is to improve patients' lives by identifying, developing and commercializing products including: XYREM, ERWINAZE, PRIALT, FAZACLO LD and HD and LUVOX CR. The product information on XYREM, ERWINAZE, PRIALT, FAZACLO LD and HD and LUVOX CR is intended only for residents of the United States. Click on the logos below to view complete prescribing information, including boxed warnings.
In addition to these products marketed in the U.S., EUSA Pharma, an international division of Jazz Pharmaceuticals, markets products outside of the U.S. in more than 80 countries. For more information please visit: www.EUSAPharma.com.
To report an adverse event or a product complaint, or to request information about our products, please click here.
Jazz Pharmaceuticals has an unwavering commitment to improving care for patients with serious medical conditions through innovative treatments. We are working to expand our current portfolio of commercial products through targeted investments in post-discovery research and development. We are working closely with healthcare professionals and patient advocates to identify significant treatment gaps where Jazz Pharmaceuticals' approach to patient care may be able to help solve problems in a unique way that will make a substantive difference for patients.
Our long-term vision includes building a development pipeline that could offer potential new treatment options for patients. Our current research and development efforts include programs to improve the current products in our oncology and psychiatry franchises, as well as other development opportunities that support our mission to improve patient's lives.
AI
Fourth Floor, Connaught House,
