Jefferies analyst David Steinberg reiterated a Buy rating and $15 price target on Nektar Therapeutics (NASDAQ: NKTR) following investor meetings with Nektar management.
Steinberg comments, "We increasingly believe NKTR shares offer a favorable risk/reward profile. Two important programs (BAX855, Movantik) will have critical clinical/regulatory catalysts in the next 2 months, with the latter seemingly de-risked post a recent Adcom. Fovista now looks like an underappreciated opportunity while 181 (potential $1B+ peak) may yet have life despite being written off. Few companies have a rich catalyst calendar like NKTR."
After spending time with management, Summer Street says it is incrementally positive on Flamel Technologies due to multiple potential catalysts in the second half of 2014. The firm expects Flamel's neostigmine for reversing muscle blocks, Bloxiverz, will near 100% market share by Q4 as unapproved neostigmines exit the market. It reiterates a Buy rating on the stock with a $25 price target.
Appears we've got a bleeder on our hands----can they survive until tomorrow---you know! Always tomorrow when the pot of gold is going to be found for those investing their money in this POS operation.
Ran out of space:
the committee only mentioned Movantik by name when referencing the individual companies. With this said--the company is going to make their recommendation as collective decision, however, IMO the FDA came away today with an understanding that AZN is the only company with the controlled 52 week study data.
General mood of those listening to the presentation--the audience gave the most attention to AZN presentation and if one had to select which of any companies got positive comments from the committee--it was AZN
I'm off to see the Orioles and Red Sox and drink some beer and hope that my observations come true.
Today's Adcom meeting just ended and these are my observations:
1) One must remember this meeting was an advisory meeting to determine what and if there should be additional data collected for drugs in this category. So keep in mind it's not this committee's role to determine if or should the drugs be approved
2) The first presentor was Dr. Gavril Pasternack, Memorial Sloan-Kettering Cancer Center. Dr. Pasternack gave an excellent overview for the need of new options for addressing OIC.
3) Jennifer Liscouski-Cubist was the first drug company presentor. She did an okay job defending Alvimopan. Their Director Regulatory Nonclinical did a very stilted and monotone presentation. Lee Techner, Clinical Research made a good presentation.
At this point the MotorMouth of Texas began his nitpicking agenda--one Dr. Milton Packer, University of Texas Southwestern Medical Center. If he said it once he said it a dozen times--"No Data to Look At" He really questoned the companies on lack of long term data to answer his questions.
3) Salix was next--Dr. William Forbes, Exec. VP Forbes did a good presentation but keep in mind he is trying to get the FDA to remove the CRL hold on collecting more data. At the end of the day---Salix team did a good job.
4) Dr. William Mezzanotte lead the AZN presentation and was assisted by Dr. Mark Sostek and Dr. William White. These guys came prepared. Not only did they have a part of their presentation dedicated to CV safety, but they also outlined a 'plan' for how they proposed collecting long term data AFTER the drug approval--and this is critical and they did a great job explaining their post-approval observational study with electronic health records and other viable sources of collecting data over 5 years.
Trying to be unbiased--AZN team delivered the goods. If the MotorMouth at the end was talking about them collecting their data post-approval. And another observation to the best of my recollection--of all the comment made by the committe
I was confused early this morning when I was attempting to get the FDA Adcom documents and mentioned that I could find the info about the AZN/NKTR submission. I've now noted that the brand name they will use for the drug is Movantik.
After wading through all the info for this meeting there is a detailed written report from AZN where they answer the issues raised by the FDA----a quick read appears to reflect a well defined response by AZN.
The agenda for this week's meeting is now up on the FDA site, however, there is no slot for discussing Naloxegol. AZN has a slot for Movantik--have they changed the name of the drug? There is a slot for Cubist and Salix---------what's up?
In reviewing my NKTR notes I was reminded that Allegan has indicated that the MAPP drug--Lovadex--is due for a decision from the FDA before the end of June. So we have two binary events pending within the next three weeks. If given the choice--come on AZN/NKTR!!!!!!!
With Adcom meeting now less than a week away the involved companies should be aware of the tone for the discussion as directed by the FDA. The public gets this information on Monday, however, if you look at PGNX today it has already traded a huge volume and already running 200,000 above the normal trading day volume. Stock is down 7%---so someone must know or thinks that the Adcom isn't going to be a cake walk for PGNX/SLXP. At least NKTR has stopped their fall, but volume today is anemic based on normal volume, however, the stock is trending higher----gives some comfort, but would prefer more volume to confirm that the news known by some is good news for Adcom.
As I mentioned in my post this first event happened and PR issued on April 2nd, 2014. This information is available on RGDO website or here on Yahoo under news section.
Good luck with your investments--RGDO is a long term hold.
There is no plan for releasing any data in the near future. Per the just released annual report RGDO clearly outlines the protocol that will be taken with the REGULATE_PCI trial.
The plan calls for three (3) interim analyses, but NO release of trial data. The first of these three interim analyses has already occurred with the recent allowance by the DSMB to allow N-STEMI subjects to be allowed into the trial. This interim look was based on 1,000 patients.
The second interim analyses will be a general safety assessment by the DSMB after 25% of the subjects have enrolled. This is expected to occur during the THIRD quarter with results of the DSMB analysis and deliberation coming 6-8 weeks later. At that time, the DSMB will recommend the continuation or discontinuation of REGULATE-PCI based on its evaluation of the safety results of those being dosed with REG1.
The final interim analysis will be performed after 50% of the subjects have been enrolled, which is expected by the end of 2014. At that time, the DSMB will assess the general safety of REG1 and will perform an analysis of efficacy. IF the DSMB determines that REG1 is not safe or that it is futile to continue the trial because of a lack of efficacy, the trial will be TERMINATED. Bad news, folks!
On the other hand, if the DSMB determines REG1 is safe and its efficacy is OVERWHELMINGLY superior to bivalirudin, a positive outcome will be declared and the trial will be considered completed. This latter determination is what we want—Good news, Folks!
There is no use in speculating that data is going to be released soon—any data at this time would be premature. We want the 50% review by the DSMB and with it coming at the end of 2014. The actual expected completion of the REGULATE_PCI trial is not until the fourth quarter of 2015.
Why is it that you never have a clue but continue to post your gibberish. Relistor (methylaltrexone bromide) is approved by the FDA. As for Entereq having no CV issues--then why in the hell do they have the following warning and restrictions on the drug that HAS BEEN approved by the FDA: WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY
Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials.
Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program.
But Klaus, you are also off base! The Cubist drug, Entereg has been approved by the FDA for about 7 years, but for another indication--not OIC. The warning labels attached to this drug is extensive and relate to the issue of CV events. The drug can only be dosed for a maximum of 15 doses.
You are correct about the status of Cubist efforts to expand the indications for the drug, and in reality its the current issue that faces Relistor (Salix/Progenics) that has caused the FDA to form this review committee on June 11-12. NKTR is a different dosing method than Relistor, however, the mode of action is why the FDA is questions the expansion of Relistor and any similar drugs...NEKTAR. The good news is that NKTR and AZN have long term data that shows no imbalance in CV events--what we have to hope for is that the FDA recognizes this fact.
June 11-12, 2014: Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
Center Date Time Location
CDER June 11, 2014
June 12, 2014 8:00 a.m. to 5:00 p.m.
8:00 a.m. to 1:00 p.m. FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committee will discuss the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists and the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Read how many times the new Honcho mentioned the words in his first at bat for this POS! Then for the first time the lemming get the hint as for what direction or path they are on--bankruptcy or liquidation. And don't you love the part of the announcement where their 'partner' has first dibs on their equipment as settlement of their outstanding exposure to a product that UNXL hasn't and can't produce. Why is always tomorrow--tomorrow that the good times start for the investors.
Ford Motor was 'capable' of manufacturing Edsel automobiles, so what difference if UNXL tells the lemming that they can produce a worthless piece of junk that nobody has or will buy? Edsels and UNXL---a product for the ages and antique shops where they store junk.
Yesterday you whined that the CEO didn’t provide you enough information in the Q report. Today you complain about the stock flying higher and too many new investors are buying the stock, thus, once again you bring your inane banality to the discussion where your demonstrable inability to bring anything of merit to the discussion is only exceeded by your willingness to point out that you don’t know that the Otis Elevator manufactures product that couldn’t even connect your utter stupid and insipid ignorance to FantasyLand.
STAMFORD, Conn., April 30, 2014 /PRNewswire/ -- Purdue Pharma L.P. announced that it has filed a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet (HYD). This investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection). The formulation has not exhibited alcohol-induced dose dumping in laboratory studies. Data from clinical trials assessing the safety, efficacy, and abuse liability of this investigational medication are also being presented today at the 33rd Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Fla.
Sentiment: Strong Buy