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INSM

Started by therman, August 17, 2005, 10:01:02 AM

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terabemo

Good luck to all holding INSM. This week will be interesting.

THe ENDO news should come out Monday afternoon or Tuesday because they can't do it until after the presentation. The big one is at 11:30AM. There will be a buying opportunity early tomorrow....but that's it.

D&Data

INFORMATIONS

2 more upgrades... ;D

FORBES:
http://tinyurl.com/g557g

BIOSPACE:
Insmed Incorporated

4851 Lakebrook Drive
Glen Allen, Virginia 23060 U.S.A.
Phone: 804-565-3000 Fax: 804-565-3500
E-Mail: [email protected]
Mini-Profile

News
Insmed Incorporated News from The BioSpace Beat

Join the BioSpace Directory of BioScience Companies
See What Your Profile Could Look Like!
Upgrade Insmed Incorporatedto a BioSpace standard profile BUY NOW!
Request More Information
http://tinyurl.com/gg3a4

PLEASE NOTICE THE NEW MAILADRESS!!

[email protected]!!!!!!!

Sofar analysts updates; both valid as of 6/26/06

AND don't forget :
A man called  Ivalexy made a good summary :

http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600811390&tid=insm&sid=1600811390&mid=110269

Pfffff, and blablablablablaaaaaaaaaaaaa;

one last thing :

INSM is included in the Russell Microcap index:

http://www.russell.com/US/Indexes/US/membership.asp

Page 9.

D.
;)


setravis

the chart.......
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

terabemo

Stalemate....waiting for the news...the news will be good...:)

Terliso

Setravis, INSM looking good, we need more volume, I think it's coming ;) :D  ;D

la-onda

short update:
INSM: Short Interest UP 53.7% to 2.7M in Jun 2006
Monday , June 26, 2006 16:18 ET

According to new short interest data from NASDAQ, short interest for Insmed Incorporated (NasdaqNM: INSM) INCREASED 53.7% to 2,684,506 shares for the month ended mid-June, 2006.

SYMBOL               MAY            JUNE          CHANGE       %CHANGE   DAYS/COVER
--------   -------------   -------------   -------------  ------------  ----------
INSM           1,747,125       2,684,506        +937,381       +53.65%           4

Based on INSM's 20-day average daily share volume of 798,140, it would require approximately 4 day(s) of buying to cover this short interest.

D&Data

#201
"Very positive and compelling presentation...."


This platform presentation will be given on Tuesday, June 27 at 11:30 a.m., Room 206 of the Boston Convention and Exhibit Center. The title of the talk is:
rhIGF-1/rhIGFBP-3 Treatment of Patients with Severe Insulin Resistance Syndromes: Preliminary Data, Fiona Regan, Marc de Kerdanet, Mehul Dattani, Andreas Sommer, Kenneth M Attie, David B Dunger. (ENDO Abstract OR40-2)
Insmed also will be presenting additional data demonstrating the safety and efficacy of IPLEX on patients with severe IGF-I deficiency. In addition, two posters will highlight the attributes of IPLEX's pharmacokinetic profile. Studies to be presented include:

Once Daily rhIGF-1/rhIGFBP-3 Treatment Improves Growth in Children with Severe Primary IGF-I Deficiency: Results of a Multicenter Clinical Trial (ENDO Abstract OR40-1, Tuesday, June 27, 11:15 a.m., room 206, Boston Convention and Exhibit Center)
Subcutaneous Administration of rhIGF-1/rhIGFBP-3 in Healthy Adult Volunteers Does Not Result in Supraphysiological Concentrations of Free IGF-I (ENDO Abstract P1-192, Saturday June 24, 11 a.m., poster session, Boston Convention and Exhibit Center)
Pharmacokinetics of Single Dose Subcutaneous Administration of rhIGF-1/rhIGFBP-3 in Healthy Adult Volunteers (ENDO Abstract P1-191, Saturday, June 24, 11 a.m., poster session, Boston Convention and Exhibit Center)
"We are extremely pleased to be presenting data at two poster and two podium presentations. We believe that IPLEX is a breakthrough drug that is showing very promising results in patients with severe insulin resistance. The preliminary data that will be presented at ENDO 2006 show that IPLEX may be beneficial for treating these patients, who are generally unresponsive to conventional therapies," remarked Kenneth M. Attie, M.D., Vice President, Medical Affairs, Insmed. "Additional data being presented supports the rationale for developing a unique dual protein therapeutic to closely mimic normal human physiology."

D.

ps: for me...news after hours....

Kublakhan

QuoteInsmed Presents Positive IPLEX(TM) Data At ENDO 2006
Tuesday June 27, 11:30 am ET

BOSTON--(BUSINESS WIRE)--June 27, 2006--Insmed, Inc. (NASDAQ: INSM - News):

Results from 3 IPLEX studies demonstrate:

    * IPLEX increases growth and improves blood sugar control in patients with severe insulin-resistance syndromes, such as Leprechaunism and Type A syndrome (1)
    * IPLEX improves growth rate in children with severe primary IGF-I deficiency(2)
    * IPLEX safely increases IGF-I levels in healthy adults without causing abnormal increases in free IGF-I levels.(3)

Insmed, Inc. (NASDAQ: INSM - News) today announced new study results that show that IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) is effective in increasing growth and improving glycemic control in patients with severe insulin-resistance syndromes, specifically Leprechaunism and Type A syndrome. In another clinical trial, once-daily treatment with IPLEX significantly improved height velocity in children with severe primary insulin growth factor-I (IGF-I) deficiencies. A third study of the pharmacokinetics of IPLEX in normal adults showed positive results, with simultaneous increases in IGF-I and IGFBP-3 and without undue increases in "free" IGF-I. Findings of all three studies were presented this week at the annual meeting of the Endocrine Society, ENDO 2006.

In a study showing the impact of IPLEX treatment on infants diagnosed with Leprechaunism (or Donohue syndrome) (Abstract OR40-2), preliminary results indicate IPLEX improved growth and glycemic (glucose) control, as well as potentially prolonged the life of at least one patient. Leprechaunism, the rarest and most severe insulin resistance syndrome, is diagnosed in infancy and in some patients can result in death in the first year of life. In this study, two patients with Leprechaunism were treated with IPLEX. Results showed an improved height standard deviation score in both patients (one from -3.3 pre-treatment to -2.4 with treatment and the second from -2.8 pre-treatment to -1.8 with treatment). Additionally the first patient achieved a reduction in HbA1c (7.6 percent pre-treatment to 6.7 percent with treatment), as well as a decrease in mean daily glucose levels (9.4 mmol/L pre-treatment to 6.6 mmol/L with treatment), indicating IPLEX produced a significant physiological benefit in this patient. This patient has been on therapy for three years and both patients currently remain on IPLEX treatment.

In the severe insulin resistance study, three adolescents with Type A syndrome, a disease in which the patient exhibits poor glycemic control despite conventional therapies, were evaluated on IPLEX treatment. Each patient entered the trial with elevated glucose levels and inadequate response to treatment with traditional therapeutic agents. Results showed that these patients, when treated with IPLEX, demonstrated approximately a 20% average decrease in HbA1c and daily glucose levels. Patients receiving IPLEX experienced decreased glucose excursions, reduced insulin usage, and noticed less prominent acanthosis nigricans (dark, velvety skin patches), which are commonly associated with severe insulin resistance. In further evidence of drug-dependent changes, all of these improvements worsened in each patient once IPLEX treatment was terminated.

"The preliminary results of this study suggest that IPLEX can be more effective than conventional diabetes therapies in patients with severe insulin resistance syndromes," said Kenneth M. Attie, M.D., Vice President, Medical Affairs, Insmed. "We look forward to the completion of these studies with IPLEX and continuing to evaluate its utility in diabetes-related disorders, particularly in those with extreme insulin resistance."

Safety and Efficacy in Children with Severe Primary IGF-I Deficiency

A second study (Abstract OR 40-1) presented at ENDO demonstrates IPLEX's safety and efficacy in children with severe primary IGF-I deficiency. A prospective, multicenter clinical trial of IPLEX administered once daily showed that treatment resulted in statistically significant, dose-dependent increases in height velocity (growth rate) with a favorable safety profile. Average height velocity in one of the treatment groups, treated with a dose of up to 2 mg/kg/day, increased from 2.0 cm/year pre-treatment to 8.3 cm/year during the first year of treatment. Children with genetic and acquired forms of growth hormone (GH) insensitivity appeared to respond equally well to treatment in this study.

IPLEX was generally well tolerated in these patients. Adverse events included injection site reactions (including erythema, lipohypertropy, and hair growth), hypoglycemia (generally rated as mild and asymptomatic), headache, and tonsillar/adenoid hypertrophy.

IPLEX Pharmacokinetics in Normal Adults Presented

Results from a pharmacokinetic study of IPLEX, presented during 2 poster presentations, demonstrate that IPLEX has unique, positive properties. The first poster (P1-191) presented the pharmacokinetic results of single-dose administration of the drug to 28 healthy adult volunteers. The investigators concluded that due to the gradual absorption and elimination of IPLEX in the bloodstream, sustained increases in levels of IGF-I and IGFBP-3 are achieved lasting more than 24 hours. These data indicate that the drug can be administered once-daily or, in certain patient populations, possibly less frequently, such as every other day. IPLEX was well tolerated during the study.

A second poster from this study (P1-192) examined the levels of free IGF-I in healthy adult volunteers after administration of IPLEX. Under normal circumstances, less than 2 percent of IGF-I circulates as the free biologically active form because of a complex physiology that keeps it bound to other proteins, principally IGFBP-3 and ALS. The IPLEX complex was designed to limit the amount of free IGF-I associated with replacement therapy, thus maintaining a physiological balance of IGF-I with IGFBP-3. Results of this study conclude the mean percent of free IGF-I did not exceed 1 percent at any time during the 72-hour sampling period, thus avoiding supra-physiologic levels of free IGF-I.

"IPLEX was designed to provide IGF-I in a stable complex with its natural binding protein, and thus mimic what occurs naturally in human circulation," said Attie. "In the pharmacokinetic study presented at ENDO, we demonstrated that the drug limits the excursions of free IGF-I levels by providing a gradual absorption of the apparently intact complex. The pharmacokinetics of this drug make it an ideal treatment for children with severe primary IGFD and, in the future, other patient populations that might benefit from once daily IGF-I replacement."

About IPLEX

IPLEX is approved in the United States as the only once daily treatment for children with short stature associated with severe primary IGF-I deficiency (Primary IGFD). IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF-I replacement therapy that also replaces deficient IGFBP-3 in these patients. The drug, which was launched in the second quarter of 2006, is also being investigated for various other indications with unmet medical needs, including severe insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS). For more information about IPLEX please go to www.go-IPLEX.com.

la-onda

 ::)

D&Data

so what to understand with that ?!
on good news...they fall !!


sell order active

la-onda

fake breakout  ??? ???
feedback is appreciated
O.

Insmed dips after weeklong rally
Tuesday , June 27, 2006 15:14 ET

By Staff Reporter

BOSTON, Jun 28, 2006 (XFN-ASIA via COMTEX) -- Shares of Insmed Inc. dipped Tuesday following a weeklong climb after the biotech drug maker released results from clinical trials testing its Iplex growth factor treatment.

Insmed fell 12 cents, or 7 percent, to $1.67 in afternoon trading on the Nasdaq at above average volume. Before the release of data, shares had risen 23 percent from last Tuesday's close of $1.46. Shares have traded between 86 cents and $3.35 over the past 52 weeks.

In one study, the company said Iplex improved height deviation scores and blood sugar levels of two patients with Donohue syndrome, the most severe form of insulin resistance that can result in death. Also known as "Leprechaunism," the rare condition is often diagnosed in infancy and results in short stature and elfin-like features.

Using Iplex for another insulin resistance disease called Type A syndrome, three adolescents were shown to have their blood sugar levels reduced by an average 20 percent. Insulin is the hormone that allows the body to regulate blood sugar.

Another study showed that growth spurts in children increased by an average of about 3.3 inches from about 0.8 inches per year in the first year of treatment in children with severe insulin growth factor-I deficiencies.

A safety study following 28 adults showed that insulin growth factor levels were increased for 24-hour periods after taking Iplex, and that the drug was well tolerated.

terabemo

The most frustrating stock in America will have its day in the sun. Very soon IMO.....I am long on this one.....50%++ is earmarked for 3-year hold. Nice retirement account IMO

terabemo

I-Watch suggests that most of the buying after the ENDO conference has been institutional. I like that... :)

terabemo

INSM $1.6

INSM's July rally factor will be 2Q 2006 earnings. I expect earnings to exceed analysts' expectations. Analysts expected 2 weeks of iPlex revenues but the company launched iPlex 4 weeks ahead of schedule. Most of the buys on Friday were at the ask with a 10K share buy the last second of trading ...and 3 cents above the ask.

http://stockcharts.com/gallery/?insm


RDCM: $2.24

RDCM has 80c/share cash no debt and strong guidance for earnings to be reported during the 3rd week of July. If the company meets guidance we could see $4+ after earnings. Interestingly, one of the last trades on Friday was for 32000 shares at the ask $2.24. I believe that RDCM will start moving up on today.

http://stockcharts.com/gallery/?rdcm


EVOL: $1.26

EVOL is superundervalued. If earnings are even slightly encouraging, EVOL will fly past $2 in NY second.

http://stockcharts.com/gallery/?evol


DO YOUR DD

terabemo

1 and 2 below will be catalysts for INSM's July rally:

1) Earnings for 2Q will likely exceed analysts' expectation by a wide margin due to the early iPlex commercial launch. During 2Q 2006, iPlex will be in the market for 6 weeks instead of the 2 weeks that analysts' had expected.

2) INSM will formally apply with the EMEA in a few weeks for iPLex approval in Europe. INSM has not ruled out a partnership with a large pharma Co. to market iPlex in Europe..

3) INSM has $60M in cash. These funds are sufficient to fund operations until mid-2007 excluding any iPlex revenues.

4) On June 13, a federal court dismissed a complaint filed by rival Tercica Inc. (Nasdaq: TRCA) claiming that INSM made false and misleading promotional statements related to its Iplex treatment for severe short stature in children.


***** CLINICAL DEVELOPMENT of INSM'S HUGE DRUG PIPELINE.

On May 15, 2006, a company representative addressing institutional investors clearly said that there will be many clinical trial results published within the next 6 months.


* NOONAN's syndrome trials. This is to expand iPlex patient base from 6,000 to over 30,000.

* Miotonic Muscular Disthrophy (MMD) clinical trials using iPlex are well under way.

Myotonic dystrophy affects an estimated 40,000 individuals in the United States.

* BP3 cancer trials....Ongoing (see ASCO news above)

BP3 has demonstrated preclinical efficacy in numerous cancer indications, including breast, prostate, liver, ovarian, and colon cancers.

* INSM-18 AT THE FOREFRONT OF NEW CANCER DRUGS....EVEN AHEAD OF PFIZER IN THIS AREA

On March 7, 2006, the Business Intelligence firm La Merie S.L. reported that antibodies are at the forefront of novel cancer therapeutics targeting the insulin-like growth factor-1 receptor (IGF-1R).

The report states that INSM along with giant Pfizer are among the leaders in this promising oncology research area. INSM-18 is a dual inhibitor of IGF-1R and Her2/neu and is the only clinical stage IGF-1R small molecule antagonist (phase I/II in prostate cancer).

http://www.pr.com/press-release/7579

ENDO 2006....On Tuesday, June 27, 2006, at this year's ENDO conference, INSM presented study results showing that Iplex is effective in increasing growth and improving glycemic control in patients with severe insulin-resistance syndromes, specifically Leprechaunism and Type A syndrome.

In another clinical trial, Iplex significantly improved height velocity in children with severe primary insulin growth factor-I deficiencies, the company said. Finally, a third study of the pharmacokinetics of Iplex in normal adults also showed positive results.

Iplex is already approved in the United States as a once-daily treatment for children with short stature associated with severe primary IGF-I deficiency.


http://biz.yahoo.com/bw/060622/20060622005174.html?.v=1


NOTE:

iPlex is a proprietary INSM drug product for the delivery of recombinant insulin-like growth factor 1 (IGF-1). It is administered as a preformed complex with a recombinant form of its natural binding protein, insulin-like growth factor binding protein 3 (rhIGFBP-3) or BP3.

BP3 helps regulate the distribution of IGF-1 and prevents IGF-1 excess. Uncontrolled IGF-1 has been linked to conditions as serious as accelerated cancer tumor cell growth.

DO YOUR DD