jd - yep - major bonus. As for what drove INSM yesterday I am thinking the rise in RUT (Russell 2000 +17.33) helped but the financial (Hercules) announcement earlier might have been better than originally thought. Maybe investors realize what JAD has been saying.....we may see approval/sales in 2015(?). Something is "up" behind the curtain. none of my other BIOs had that kind of momentum yesterday and many were actually RED.
Oh that's right you made 10% yesterday after the $16 call while the rest of us made about 17.58% since Tuesday's $13.65.
Dec 18, 2014 14.56 16.15 14.53 16.05 889,000 16.05
Dec 17, 2014 13.70 14.47 13.62 14.37 885,100 14.37
Dec 16, 2014 13.73 14.17 13.65 13.70 369,400 13.70 (congrats to who called the new lows in the $13.70's)!!
Sorry for the partial but here is some of the pertinent details - GLTA
The opinion adopted by the CHMP at its December 2014 meeting is an intermediary step on Mysimba’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation
The approval to market a medicine in one, several or all European Union Member States.
has been granted, decisions about price and reimbursement will then take place at the level of each Member State considering the potential use of Mysimba in the context of the national health system of that country.
The marketing authorisation applicant for Mysimba is Orexigen Therapeutics Ireland Limited.
CHMP Highlights 12/19/14
Mysimba recommended for approval in weight management in adults
Medicine to be used in addition to reduced-calorie diet and physical activity
The European Medicines Agency (EMA) has recommended granting a marketing authorisation
The approval to market a medicine in one, several or all European Union Member States.
for Mysimba (naltrexone / bupropion) for weight management of overweight or obese adults. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity.
The medicine, which will only be available on prescription, provides a treatment option for adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or a BMI of 27 kg/m2 to
Orexigen Therapeutics Submits Contrave Marketing Authorization Application to European Medicines Agency
SAN DIEGO, Oct. 3, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the company has submitted the Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) utilizing the EMA's Centralized Procedure. Orexigen is seeking approval for Contrave (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification.
Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.
"Obesity is one of Europe's great health care challenges, with the prevalence of obesity tripling in many European countries in the past few decades," said Michael Narachi, CEO of Orexigen. "We believe, if approved, a medicine with Contrave's safety and efficacy profile, including safety information derived from the ongoing cardiovascular outcomes trial, can be an important part of the solution for the management of obesity in Europe."
Orexigen is currently evaluating Contrave in the Light Study, a cardiovascular outcomes trial with more than 8,900 patients randomized to Contrave or placebo. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.
Earlier this year, Orexigen met with the European rapporteurs to discuss the filing strategy of the Contrave MAA, and both were supportive of the company's plan to submit the MAA in advance of the Light Study interim analysis and to have cardiovascular etc.
google biotechnologyevents (OREX)
Orexigen Therapeutics (OREX) had a nice pop late in the day on Wednesday, up 47 cents, or 8%, to $6.38 on nearly 4 million shares. It has been going in fits and starts recently. When you see a pop, pullback and pop, you expect a consolidation, which it got, but it didn't follow-through and consolidated longer than I expected. But then some volume came into it, and the stock exploded in the last three sessions. If it gets through the spike-high at around $6.50, it could reach $7.50-.75 very quickly, my first swing-trade target. Beyond that, $11.50-.$1175, the high from three years ago.
Geez Louise I was "guessing" $16 by 1/15/15 but who saw this coming today? Terry, I accept your apology for questioning my post of Insmed's future PPS. One (actually MANY) of us is/are blushing and the other is FLUSHING (driving the porcelain bus)!!
Stupid? Try 14.65% gain from $13.65 - in your case that was $2 for your 1 share invested IF you sold at $15.65. A decent goal for today so, only .35 to go!!!
Terry, Rather than look back to last April, why not TALK about the last few days (when blushing). I will say thanks for deleting your post on garbage "spewing". Thinking about it, most of your posts should be deleted for that reason!
Zake/Jad, I saw this as a positive since it is being done now and with little "fanfare". 77K shares won't really hurt and I would rather have the "insurance" if/when needed. The PPS was $14.13 but that is a non-issue.
On December 15, 2014, Insmed Incorporated (the "Company") and its domestic subsidiaries (together with the Company, "Borrowers") and Hercules Technology Growth Capital ("Hercules") and several of its affiliates entered into a third amendment (the "Third Amendment") to the Loan and Security Agreement (the "Loan Agreement"). In connection with the Third Amendment, Borrowers paid a commitment fee of $25,000, and at the closing, Borrowers paid a facility fee of $125,000. Under the Third Amendment, the amount of borrowings was increased by $5 million to a total of $25 million and the interest-only period was extended through December 31, 2015. In addition, in the event the Company receives $90 million in cash proceeds from the completion of certain types of equity financings, subordinated debt financings, and/or up-front cash payments from corporate transactions prior to December 31, 2015, the Borrowers will have the option to extend the maturity date of the loan to January 1, 2018. If the Borrowers elect to exercise such option, they must pay Hercules a $250,000 fee.
In connection with the Third Amendment, on December 15, 2014, the Company entered into a Stock Purchase Agreement with Hercules pursuant to which the Company issued 70,771 shares of its common stock, par value $0.01 per share ("Common Stock") (which represents less than 1% of the outstanding Common Stock as of the date hereof), at a price of $14.13 per share (the closing price of the Company's Common Stock as reported by the NASDAQ Stock Market on December 12, 2014), for an aggregate purchase price of approximately One Million Dollars ($1,000,000). The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended (the "Act") and may not be offered or sold in the United States in the absence of an effective registration statement or exemption from the registration requirements under the Act. etc.
"Any one watching drug stocks like Orexigen Therapeutics (OREX) these days knows that European Union reviews are a big deal. In fact, over the next 16 days, the stock could pick up further buy interest, as the European Medicine Agency gets set to announce its recommendation for potential approval of Contrave for weight loss.
Helping a bit, Wells Fargo reiterated an outperform rating on the stock, with a target price range of $9.50 to $10.50, as we near the European Committee for Medicinal Products for Human Use (CHMP) outcome.
Better yet, the company just posted better than expected earnings. Q3 2014 earnings of $11.3 million – or nine cents a share – beat estimates calling for a loss of 13 cents. It even blew away revenue estimates of $8.93 million with $30.98 million posted revenue.
September 2014 approval has been a boon for the stock, too. In an effort to combat obesity the FDA finally approved the drug after its June 2014 postponement. More than a third (34.9% or 78.6 million) of U.S. adults are obese, notes the Centers for Disease Control and Prevention.
That means 349 people out of every 1,000 is overweight or obese.
If the current trend continues, 43% of U.S. adults could be obese, according to the American Public Health Association and Partnership for Prevention, adding $344 billion in costs to the health care system. On top of that, 12.7 million children aged two to 19 are considered obese. That’s a problem. And if weight loss drugs can help, more power to them.
If all goes according to plan, the OREX drug could see $634 million in sales by 2020, notes Wells Fargo. OREX is even hoping Contrave can be used as a diabetes treatment, which could raise OREX sales potential to $1.2 billion by 2020. Couple that with approval potential in Europe and the $743 million stock could be off to the races!!!
Not that it matters but i thought WF changed the PT to $9.50 - $10.50 in November. Remember, we have an approved drug (Contrave) already in the US (by the FDA (or even the FTA)) and that alone makes OREX attractive. EMA approval is even better and who knows where this lands (north of $10 most likely).
gt - Terry posted that my post was "GARBAGE" and all I was doing was pumping and running or something like that. He even insinuated (again) that I am Kevin, BWD and some others all into one. THEN he deletes his post after I responded (not too nicely) to his lies and whatever. More important here, I believe Insmed will get back to $16 within the next 4 weeks (being optimistic). The market recovered a little today and we moved north quite a bit. PS. Probably got upset because Bugsey and I "BLUSH" because we are so savvy in investing (LOL) - I promise you - I am NOT all that accurate!!!