The FACT that Checks' NTM post received 3 thumbs down (which I guess means he is a liar or these 3 idiots don't want to hear anything GOOD) really points to the resident moron (and his clones). The next time someone posts here that TERRY is a savvy investor and knows/predicts what will happen here AFTER the fact, I am joining the jad parade of attacking. Checks - thank you for posting these updates and besides being invested in Insmed, it is great to hear of the successes of Arikayce. Terry, if you have NOTHING good to post then post nothing at all!!!
Also, Orexigen met with PJ on Tuesday (Leerink the past 2 days hmmm)
Orexigen remains a top mid-cap pick for 2015 at Piper Jaffray
Piper Jaffray reiterates Orexigen as a top mid-cap pick for 2015 after hosting meetings with management. Piper believes obesity drugs are getting traction and that Orexigen's recent approval in Europe will likely to support a partnering push. The firm thinks a non-U.S. partnering deal could be announced this year. It reiterates an Overweight rating on Orexigen with a $26 price target.
Blank, Obviously the deck is impressive and has more details and numbers than ever, broken down. We now include Canada and New Zealand in the PHIII ROW NTM trial (80 sites by end of June). But, this April presentation looks more like a "sales" job then an update for a conference (any scheduled?). If I was a "buyer" interested in cornering the NTM ROW market and now see the potential billions of revenue in the next 5 years, why would I wait until some other company grabs Insmed? No Analyst upgrades or initiations? Something is amiss here.
I believe that Orexigen was in "contact" with Forbes after the first few articles. The main CLAIM was the "falsified" data inference. Everyone here (I mean everyone) would agree that if the data was "made up" then all of us would see Orexigen as the wrong entity. However, many of us (myself included) believe the data was in fact true (no matter how "premature 25% can be considered) and that 25% covered almost 2500 patients, any statistician could equate the data to being "interesting" at least. Yes, we need more data (soon to come) but there was NEVER an issue with the data being factual until this past week. ALL of us were surprised. This is a HUGE story and could be a"breakthrough" as one SA poster wrote. We will know more tomorrow.
Just a tidbit(ARNA Trolls take heed):
Looking at market share, the dynamics of the Contrave launch are showing through. Contrave is continuing to take share away from its rivals. This past week both Belviq and Qsymia from Vivus (NASDAQ:VVUS) went lower in market share of these new obesity drugs, while Contrave saw market share growth. This is particularly true when looking at new scripts. Contrave is even beginning to demonstrate a rapid growth trajectory in refills. This week Belviq carried 39.45% of the scripts (down from 39.56%), Qsymia had 30.58% (down from 31.84%), and Contrave had 29.97% (up from 28.60%). Several charts below show the dynamics of the market and illustrate the challenges Belviq is seeing. The bottom line here is that Contrave is seeing the types of trajectory that Arena needs to be seeing. Excuses will not deliver the needed shift. Something dramatic needs to happen sooner rather than later." etc.
Will Lewus is the former President, CFO and Co-Founder of Aegerion Pharma ? Terry who is Will Lewus? I see you are back to "clipping" anyone's posts (excuse me, drivel) that may have some validity to it.
Agree, Especially relates to the actions/reactions on this board:
"So, what is the bottom line?
The bottom line is that investors in Orexigen need to follow this story closely. In my opinion, the risk of Contrave being pulled from the market is very minimal. Such an action would be similar to throwing the baby out with the bath water. If fines are involved, they will likely be something that the company can absorb. If indeed the heart data is true, it could be a big win for the company. It may take a whole new study and a few years to get the data published, but if the concept is understood, then patients may already be seeing a benefit. Orexigen is not trying to market a heart medicine at this stage. The company is trying to market an anti-obesity medication that does not increase cardiovascular risk.
Sector investors need to step back and look at whether their choice of a company to invest in is jading the compassion that should exist within all of us. I have seen many times where investors state that one or another of these drugs poses no cardiovascular risk based on the studies to-date, when none of these cardiovascular studies is complete. It is ironic seeing the rhetoric of discounting the results of one drug, while touting results of another. Step back and use a little common sense. If Contrave does indeed have cardiovascular benefits, the compassionate side of anyone should celebrate it. Stay Tuned!
Highlights of the fourth quarter of 2014 and recent weeks include:
• Received validation of the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ARIKAYCE following the approval of the Pediatric Investigation Plan (PIP) by the EMA’s Pediatric Committee;
• Advanced progress of the Company’s phase 3 global trial (the “212” trial) for patients with treatment resistant nontuberculous mycobacteria (NTM) lung infections including the activation of multiple clinical trial sites;
• Appointed Myrtle Potter to its Board of Directors;
• Appointed Dr. Olaf Bartsch as Vice President - Europe, General Manager - Germany and Dr. Francois Cornu as Vice President - Europe, General Manager - France to commence the build-out of operations in Europe. Both Drs. Bartsch and Cornu will report to Will Lewis, President and Chief Executive Officer;
• Launched a comprehensive NTM disease state awareness website www.ntmfakten.de for the education of healthcare providers in Germany;
• Entered into a partnership with the European Respiratory Society (ERS) that established an inaugural award in NTM research entitled, ERS Research Award: Innovation in Non-Tuberculous Mycobacteria Science and Medicine, which is designed to advance the science and understanding of NTM lung disease; and
• Company to host an Analyst and Investor Day in New York City on Tuesday, March 24.
“We remain focused on our primary goal of advancing the 212 trial, our global phase 3 study in NTM patients who failed prior standard-of-care treatment. We activated multiple sites and we continue to expect preliminary top-line clinical results in mid-2016,” said Mr. Lewis. “We are pleased with our progress in Europe on several fronts. The validation of our MAA filing with the EMA starts the formal review process for ARIKAYCE, the hiring of Drs. Bartsch and Cornu to lead our operations and the partnership with ERS show our commitment to bringing ARIKAYCE to patients with NTM etc.
•Contrave's total scripts pass Qsymia.
•Contrave is gaining on Belviq.
•With European approval, Orexigen can be aggressive.
Sales of the anti-obesity medication Contrave from Orexigen (NASDAQ:OREX) saw a week-over-week improvement of 3.83% this week, with sales just above 11,400, according to industry tracker IMS Health. Once again, Contrave was the winner in total scripts (TRx) and new scripts (NRx). Contrave, as the lowest priced anti-obesity option among the new pills, has enjoyed a very good launch trajectory and each week continues to chip away at the market share of competitors.
Contrave is enjoying good trajectories on all three fronts of the script picture. Total scripts establish overall market share, new scripts deliver front-end growth, and refills demonstrate how "sticky" the product is with consumers. Contrave reached the 11,000 script level in just 23 weeks. Competitor Belviq just attained that level at the end of last August after 63 weeks on the market. The same sales level has been a plateau of sorts for competitor Vivus (NASDAQ:VVUS). This week, for the first time, Contrave sold more overall scripts than Qsymia.
New scripts is where Contrave seems to have its bread and butter. Contrave passed Qsymia in new scripts a few weeks ago, and is now closing in on Belviq. This is happening without a direct to consumer advertising campaign, which is impressive. If or when marketing partner Takeda launches a campaign, it is possible that sales will shift into another gear. etc.
Orexigen did get European approval this week and that remains the current focus that drives the equity. Orexigen maintains all rights in Europe and is seeking a partner. An announcement of a partnership deal with its associated cash is the next catalyst. This buys time to continue to drive sales volume and extension revenue. By the time revenue becomes more of a focus, Orexigen may well be on its way to launches in Europe. Stay Tuned!
In case we were not sure (Strong Buy and Conviction Buy would be self-explanatory):
Ratings System Definitions:
Buy: Stock is expected to outperform against the market over next 12 months.
Hold: Stock is expected to perform in line with the market over next 12 months.
Sell: Stock has more downside risk than upside potential at current prices. Expect shares to underperform the market from current prices.
Outperform: Stock is expected to outperform within its industry over next 12 months.
Market Perform/Neutral: Stock should perform roughly in line with current market. Neither encourages purchase or sale of these securities at current prices.
Underperform: Stock's total return is expected to underperform the industry average over next 12 months.
Overweight: Stock is expected to perform better than the broad market over next 12 months.
Equalweight: Stock is expected to perform in line with broad market over next 12 months.
Underweight: Stock is expected to perform worse than broad market over next 12 months.
Well if in FACT there could be 3 suitors (and Shire makes 4), WL's stance of going alone is excellent posturing. IF that is occurring, the BO offer will exceed $3B (now we are about $1B Mkt Cap). Right now Insmed is on the verge of owning the NTM market but let's not rule out other possible benefits (CF etc.). I do not think the BOD (added experienced members in the last year) of Insmed will entertain anything less than $3B ($60/shr) so, maybe nothing happens for awhile. In the meantime, PJ (Schimmer) reiterated $51 PT and Janney started with $33/shr a month ago. If Cowen (Baral) upgrades to $35/shr, then the $20's should remain unless Nasdaq/BIOS take another dump. The main thing is we are WAY better off than a year ago.
The trend about 2 weeks ago was setting 52 wk highs almost daily. The overall market looks GREEN today so far. Insmed should soon trade again over the $22 range.
Markets turning "slightly red (futures) and it is a Friday. However, Insmed has maintained its $20+ PPS through all the recent turmoil and volatility. It would be quite nice to close the week above $20. Let's see if volume picks back up today.
Also, they have NO influence over the SEC and the SEC has requirements that MUST be met. OREX followed those requirements. The FDA says OREX didn't need to file the patent - hmmmm?
"The early study results did show overwhelming positive results, and this results were not tainted in any way as per the FDA's own assessment in September. Even the new data set, that has more than a year of additional study time on thousands of patients could not be very tainted, because the early results did not become widely known until this week. If the results had been known widely, the stock price would already be much higher and certainly wouldn't have been near 3 dollars a few months ago. Given the efficacy and safety shown in the early results, the new data, available today, should tell the FDA enough to stop the study one way or another. Therefore, this whole episode of the FDA and members of the DMC making comments to journalists seems to be nothing more than sour grapes, and they have used their anger to try and harm public investors and the financial condition of the company. Don't know what type of confidentiality and gag clauses the DMC members sign, but this is surely going to cause a mess for the FDA."