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Targacept Inc. (TRGT): TRGT is a development-stage biotech that discovers and develops NNR Therapeutics, a new class of drugs for the treatment of CNS diseases and disorders. Guru funds together added a net $2 million in Q3 to their $2 million prior-quarter position in the company. The top guru fund buyer was Balyasny Asset Management ($3.2 million). Its shares took a severe beating last year, down by almost 80%, as first its first of four RENAISSANCE phase 3 trials of TC-5214 as an adjunct treatment in patients with major depressive disorder failed to meet primary endpoints, and then in mid-December it released results from the second phase 3 RENAISSANCE trials that also did not meet its primary endpoints.
http://seekingalpha.com/article/317372-micro-cap-biotech-stocks-legendary-fund-managers-are-accumulating?source=yahoo
TRGT +3.39% @ 5.79, 170K (chart)
http://stockcharts.com/h-sc/ui?s=trgt
Nice news this AM
TRGT LOD 5.29
TRGT HOD 5.54 - 13% gain
Nice to see some action on this one
Nice to see some action on this one
TRGT HOD 6.00
TRGT new LOD 4.92
Looks like this one is not for the weak hearts !!
Try $5.25.....
between this and EK i am going to need to start meds
Same here. Holding for at least 9 bucks now! lol
Me too, lifter- bought as bounce early Nov, sold most within a day for about 6% profit but holding rest as potential reward is good.
Financials are decent and they've got options.
Speaking of another kind of options, call activity is up!
MG
on a steady move up, bought this as a bounce play but showing signs of steady climbing has me holding this for weeks
7. Targacept, Inc. (TRGT): Engages in the design, discovery, and development of novel Neuronal Nicotinic Receptors (NNR) Therapeutics for the treatment of diseases and disorders of the central nervous system. Market cap of $249.68M. Levered free cash flow/enterprise value at 14.51% (enterprise value at 43.36M and levered free cash flow at 6.29M). This is a risky stock that is significantly more volatile than the overall market (beta = 3.02). The stock has performed poorly over the last month, losing 61.06%.
http://seekingalpha.com/article/312327-10-biotech-stocks-undervalued-by-levered-free-cash-flows?source=yahoo
Targacept article -- >>> Our Top Biotech Stock Idea
>>> Our Top Biotech Stock Idea
By CAPS' Weekly Top Stock Idea
November 18, 2011
http://www.fool.com/investing/high-growth/2011/11/18/our-top-biotech-stock-idea.aspx
This Week's Pitch:
Disclaimer: Yesterday I took a major CAPS kick to the teeth when the company reported that the RENAISSANCE 3 phase III trial of TC-5214 for major depression did not meet its primary endpoint. Not only did I green thumb Targacept, but I identified it in May as a GBMB portfolio buy at 20 after it had declined from peaks near 30 over a few months. Fortunately, my skepticism over the current paradoxical strength in the broad markets caused me to place a virtual moratorium on long investments until the debt crisis in Europe has resolved. Therefore I sustained no real money losses when the share price went into the dumper.
I've long held the view that when you advise buying a stock and you end up being completely wrong, you should sit down and shut up. This is apparently a rare concept in the financial media and on blog sites like Seeking Alpha. However, CAPS is a game and I'm going to continue to play Targacept in the game, and when I rate stocks I always write a pitch. So if you believe, like I do, in the integrity of fading away quietly then read no further.
Targacept conveniently dished the bad news only a week after reporting their third quarter financial results. So we know that the company has 271M in cash, 2M in long term debt, and an uptick in quarterly burn to 9M. Meanwhile, the market cap at the close Tuesday was 254M. Yes, that's 15M below the net liquid asset balance. Now, it's not unusual for weak biotechs to be valued below cash-see Insmed and Adventrx-but there are important differences with respect to Targacept.
First is the sheer quantity of the cash. Insmed has 85M to back a market cap of 80M. Adventrx has 38M to back a market cap of 26M. Targacept has a whopping 271M in cash. Even if they maintain the higher 9M burn they have enough cash for seven and a half years of operations. TC-5214 may have brought a lot of pain today, but let's not forget it brought in 200M from Astra Zeneca [ (NYSE: AZN ) ] in January 2010 and powered an 80M dilutive financing in May 2011.
The second issue is future prospects. Adventrx has two busted me-too cancer drugs and a cheaply acquired moonshot for sickle cell. Insmed has a phase III antibiotic on FDA clinical hold for a cancer signal in animal studies. Investors could be forgiven for thinking that these companies will simply use up their cash fruitlessly a la Myrexis. Targacept, on the other hand, has four drugs besides TC-5214 in advanced clinical trials. The most promising of these, AZD3480, is already in a phase IIb trial in Alzheimer's being run by Astra Zeneca. Phase II trials of TC-6987 in asthma and diabetes will be completed in H1 2012. And furthermore, it's important to remember that RENAISSANCE 3 was only one of four phase III efficacy trials of TC-5214 in progress. The remaining trials will provide topline data in H1 2012.
I think it would be foolhardy to ascribe much value to TC-5214, and the stock could suffer further if Astra Zeneca declines to pick up an option on AZD1446 for Alzheimer's later this year. But I've looked at this situation closely and everything about it is saying over-reaction. For some reason it reminds me of the pummeling Intermune took after the FDA rejected pirfenidone in May 2010. We know how that story turned out. Anyone could be excused for giving speculative stocks like baby pharmas a wide berth given the current imbalance between the markets and the real global economic situation. But if you're looking for something in the sector that has a good chance of bouncing back regardless of the economic headwinds, Targacept may be for you
<<<
>>> Targacept Announces Initiation of Two Phase 2 Studies of TC-5619
Press Release: Targacept, Inc.
Mon, Dec 5, 2011
http://finance.yahoo.com/news/Targacept-Announces-bw-2645752225.html?x=0
WINSTON-SALEM, N.C.--(BUSINESS WIRE)-- Targacept, Inc. (NASDAQ: TRGT - News), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.
“Our prior clinical findings with TC-5619, particularly the improvements in negative symptomatology in a study in schizophrenia patients and on both investigator-rated and subject-rated scales in the inattentive-predominant dataset in a study in adults with ADHD, have us enthusiastic about its potential in both areas,” said Geoffrey C. Dunbar, M.D., Targacept’s Senior Vice President, Clinical Development and Regulatory Affairs and Chief Medical Officer.
“Currently available treatment options are not well suited for ADHD patients whose challenges are predominantly on the inattentiveness side,” said Paul Newhouse, M.D., Professor of Psychiatry and Director, Center for Cognitive Medicine, Department of Psychiatry at the Vanderbilt Kennedy Center. “There is a compelling need for mechanistically novel, well-tolerated medicines to treat these patients.”
About the Phase 2b Study in Patients with Schizophrenia
The Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted approximately 25% at sites in the United States and approximately 75% at sites in Eastern Europe. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized cognitive test battery, and the University of San Diego Performance-Based Skills Assessment, brief version. The study is designed to enroll approximately 450 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a four-week screening period, followed by a 24-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 50mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose).
About Negative Symptoms and Cognitive Dysfunction in Schizophrenia
Schizophrenia is a chronic, severe and disabling form of psychosis. In addition to positive symptoms such as delusions, hallucinations and disorganized speech, recognized features of the disease include negative symptoms, such as anhedonia, affective flattening, avolition, social withdrawal and alogia, and impairment in cognitive function, such as executive function, attention, vigilance, memory and learning. These negative symptoms and cognitive impairments play a primary role in the inability of many schizophrenic patients to function normally. The market research firm Decision Resources has estimated there were approximately 4.6 million people with schizophrenia in the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan) in 2010 and that about 80% of persons with schizophrenia are cognitively impaired. Estimates as to the prevalence of schizophrenia patients who suffer from negative symptoms vary. There is currently no drug approved in the United States or Europe specifically for either negative symptoms or cognitive dysfunction in schizophrenia.
About the Phase 2 Study in Adults with Inattentive-Predominant ADHD
The Phase 2 study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted solely at sites in the United States. The primary outcome measure is the Inattention subscale of the Conners’ Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV). The study is designed to enroll approximately 80 adults with inattentive-predominant ADHD. The study design includes a four-week screening period, followed by a four-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 25mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose). The study is powered to demonstrate a statistically significant difference between TC-5619 and placebo on the primary outcome measure using a one-sided test and a significance level of 10% (p ? 0.10).
About Inattentive-Predominant ADHD
The principal characteristics of ADHD, a condition that develops during childhood, are inattention, hyperactivity and impulsivity. The Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) segregates ADHD into predominantly inattentive, predominantly hyperactive/impulsive, and combined, a diagnosis that is based on an assessment of the respective numbers of inattention and hyperactivity/impulsivity criteria met by a patient. Decision Resources estimated that more than 60% of pediatric ADHD cases in the world’s seven major pharmaceutical markets in 2010 were inattentive-predominant, with an estimated total ADHD prevalence of approximately 23.5 million adults and 23.8 million children and adolescents.
About Targacept
Targacept is developing a diverse pipeline of innovative NNR Therapeutics(TM) for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, a unique class of proteins that regulate vital biological functions that are impaired in various disease states. Targacept’s lead program, TC-5214, is being co-developed with AstraZeneca and is in Phase 3 clinical trials as an adjunct treatment for major depressive disorder. Targacept leverages its scientific leadership and proprietary drug discovery platform Pentad(TM) to generate novel small molecule product candidates to fuel its pipeline and attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.
<<<
TRGT +2.81% @ 7.69 (HOD), 226K (news & chart)
http://stockcharts.com/h-sc/ui?s=TRGT
Targacept Announces Initiation of Two Phase 2 Studies of TC-5619
BY Business Wire 8:00 AM ET 12/05/2011
WINSTON-SALEM, N.C.--(BUSINESS WIRE)-- Targacept, Inc. (TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of two clinical studies of TC-5619, a Phase 2b study evaluating the product candidate as a treatment for negative symptoms and cognitive dysfunction in schizophrenia and a Phase 2 study evaluating the product candidate in adults as a treatment for attention deficit/hyperactivity disorder (ADHD), inattentive-predominant. TC-5619 is a highly selective modulator of the alpha7 neuronal nicotinic receptor.
“Our prior clinical findings with TC-5619, particularly the improvements in negative symptomatology in a study in schizophrenia patients and on both investigator-rated and subject-rated scales in the inattentive-predominant dataset in a study in adults with ADHD, have us enthusiastic about its potential in both areas,” said Geoffrey C. Dunbar, M.D., Targacept’s Senior Vice President, Clinical Development and Regulatory Affairs and Chief Medical Officer.
“Currently available treatment options are not well suited for ADHD patients whose challenges are predominantly on the inattentiveness side,” said Paul Newhouse, M.D., Professor of Psychiatry and Director, Center for Cognitive Medicine, Department of Psychiatry at the Vanderbilt Kennedy Center. “There is a compelling need for mechanistically novel, well-tolerated medicines to treat these patients.”
About the Phase 2b Study in Patients with Schizophrenia
The Phase 2b study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted approximately 25% at sites in the United States and approximately 75% at sites in Eastern Europe. The primary outcome measure is the Scale for the Assessment of Negative Symptoms (SANS). Key secondary outcome measures include the CogState Schizophrenia Battery (composite score), a computerized cognitive test battery, and the University of San Diego Performance-Based Skills Assessment, brief version. The study is designed to enroll approximately 450 patients with stable schizophrenia who are taking a fixed dose of an atypical antipsychotic. The study includes a four-week screening period, followed by a 24-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 50mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose).
About Negative Symptoms and Cognitive Dysfunction in Schizophrenia
Schizophrenia is a chronic, severe and disabling form of psychosis. In addition to positive symptoms such as delusions, hallucinations and disorganized speech, recognized features of the disease include negative symptoms, such as anhedonia, affective flattening, avolition, social withdrawal and alogia, and impairment in cognitive function, such as executive function, attention, vigilance, memory and learning. These negative symptoms and cognitive impairments play a primary role in the inability of many schizophrenic patients to function normally. The market research firm Decision Resources has estimated there were approximately 4.6 million people with schizophrenia in the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan) in 2010 and that about 80% of persons with schizophrenia are cognitively impaired. Estimates as to the prevalence of schizophrenia patients who suffer from negative symptoms vary. There is currently no drug approved in the United States or Europe specifically for either negative symptoms or cognitive dysfunction in schizophrenia.
About the Phase 2 Study in Adults with Inattentive-Predominant ADHD
The Phase 2 study is a double blind, placebo controlled, randomized, parallel group trial planned to be conducted solely at sites in the United States. The primary outcome measure is the Inattention subscale of the Conners’ Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV). The study is designed to enroll approximately 80 adults with inattentive-predominant ADHD. The study design includes a four-week screening period, followed by a four-week treatment period during which patients receive either one of two doses of TC-5619 (5mg or 25mg) or placebo daily, randomized in a ratio of 2:1:1 (placebo, low dose, high dose). The study is powered to demonstrate a statistically significant difference between TC-5619 and placebo on the primary outcome measure using a one-sided test and a significance level of 10% (p ? 0.10).
About Inattentive-Predominant ADHD
The principal characteristics of ADHD, a condition that develops during childhood, are inattention, hyperactivity and impulsivity. The Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) segregates ADHD into predominantly inattentive, predominantly hyperactive/impulsive, and combined, a diagnosis that is based on an assessment of the respective numbers of inattention and hyperactivity/impulsivity criteria met by a patient. Decision Resources estimated that more than 60% of pediatric ADHD cases in the world’s seven major pharmaceutical markets in 2010 were inattentive-predominant, with an estimated total ADHD prevalence of approximately 23.5 million adults and 23.8 million children and adolescents.
About Targacept (TRGT)
Targacept (TRGT) is developing a diverse pipeline of innovative NNR Therapeutics(TM) for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, a unique class of proteins that regulate vital biological functions that are impaired in various disease states. Targacept’s lead program, TC-5214, is being co-developed with AstraZeneca and is in Phase 3 clinical trials as an adjunct treatment for major depressive disorder. Targacept (TRGT) leverages its scientific leadership and proprietary drug discovery platform Pentad(TM) to generate novel small molecule product candidates to fuel its pipeline and attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.
to avg down or loose $300 or
wow I missed big on this turd
Targecept dropped $11.50 to $7.50
Key AZ/Targacept depression drug flunks first Phase III test
November 8, 2011 — 6:49am ET | By John Carroll
AstraZeneca | Targacept | TC-5214
* AZ drops its option on Targacept schizophrenia program
* Targacept scores blockbuster $1.2B deal with AZ
* Targacept schizophrenia drug meets Phase II goal
* Targacept ADHD candidate shows disappointing results in Ph2 trial
* Targacept gets $200M payment from AstraZeneca
The high-profile depression drug TC-5214 has failed the first in a string of Phase III studies, dealing AstraZeneca's struggling R&D operation another stinging setback and walloping Targacept with a meltdown in its share value this morning.
Two years ago AstraZeneca ($AZN) paid Targacept $200 million upfront and promised another billion dollars in milestones to in-license the drug from the biotech, an R.J. Reynolds spinout which had used the science of nicotine to develop a product that would tamp down over-stimulated nicotine receptors in the brain, which are believed to play a role in depression. Tackling a new pathway to treating the disease was always risky, as is anything new in the depression field, but the market opportunity for an add-on treatment would be enormous.
Investors were in an unforgiving mood this morning, though. Targacept ($TRGT) shares plunged 50% in pre-market trading and even AstraZeneca's shares felt the impact of the trial failure.
AstraZeneca had been so impressed by the drug's potential it committed a budget for five late-stage trials. Renaissance 3 was the first to deliver data and its failure leaves the entire program under a dark cloud. In a short release, AstraZeneca simply noted that "the study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale after eight weeks of treatment with TC-5214 as compared to placebo."
AstraZeneca is committed to seeing out the next three Phase III studies, which will read out in the first half of next year. The pharma company had been expected to file for an approval in the second half of 2012.
- here's the press release
- read the Reuters story
Related Articles:
Key AZ/Targacept depression drug flunks first Phase III test
Add-on depression meds a bright spot in eroding market
AZ drops its option on Targacept schizophrenia program
Read more: Key AZ/Targacept depression drug flunks first Phase III test - FierceBiotech http://www.fiercebiotech.com/story/key-aztargacept-depression-drug-flunks-first-phase-iii-test/2011-11-08#ixzz1d9Nvb35Y
Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech
ehhh lots of posturing at the 8.19 -8.22 area hope it moves
Nice!
no bounce you damn dirty APE !
in tgrt 600 @8.2
on watch for bounce here 8.22
Still around surf? You going to play this one through?
3. Targacept, Inc. (TRGT): Engages in the design, discovery, and development of novel Neuronal Nicotinic Receptors (NNR) Therapeutics for the treatment of diseases and disorders of the central nervous system. Market cap of $529.41M. The stock has lost 26.61% over the past quarter. Net institutional shares purchased over the current quarter at 4.4M, which is 15.29% of the company's 28.77M share float. This is a risky stock that is significantly more volatile than the overall market (beta = 3.19). The stock has lost 28.36% over the last year.
http://seekingalpha.com/article/295693-8-underperforming-biotech-stocks-being-bought-by-the-smart-money?source=yahoo
27-Jul-11 MKM Partners Initiated Buy
Targacept(TRGT_)
The event: Phase III study of TC-5214 as add-on therapy for patients with major depressive disorder.
The timelines: Top-line results from one or more of the four phase III studies expected in the fourth quarter.
The stakes: Targacept partner AstraZeneca(AZN_) is conducting a large phase III study program for TC-5214 in major depressive disorder. TC-5214 is a potential blockbuster depression drug if the phase III studies are successful.
http://www.thestreet.com/story/11180428/1/more-hot-biotech-trades-for-second-half-2011.html
I'm stunned that there's no buzz on TRGT particularly in light of the fact that last week there were some nice insider purchases.
Where is everyone?
Targacept TRGT Needham Buy » Strong Buy $32 » $32
Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1La2sPUjZ
7:56AM Targacept announced that AstraZeneca (AZN) will not exercise its option to license Targacept's product candidate TC-5619 (TRGT) 24.18 : Co announced that AstraZeneca (AZN) will not exercise its option to license Targacept's product candidate TC-5619. As a result, Targacept retains full rights to the compound, a highly selective alpha7 neuronal nicotinic receptor modulator.
8:55AM Targacept presents statistically significant results for TC-5619 on measures of cognitive dysfunction in schizophrenia and negative symptoms of schizophrenia (TRGT) 26.18 : Co announces the presentation of data from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia at the International Congress on Schizophrenia Research in Colorado Springs, Colorado. Results presented at ICOSR showed statistically significant superiority of TC-5619 over placebo on secondary efficacy outcome measures assessing improvement on cognitive dysfunction in schizophrenia and negative symptoms of schizophrenia. Co announces that TC-5619 met protocol-defined success criteria on the study's primary efficacy outcome measure, the Groton Maze Learning Task of the CogState Schizophrenia Battery, and other top-line results in January 2011.
8:56AM Targacept announces TC-5619 did not meet the primary efficacy outcome measure (TRGT) 25.03 : Co announces top-line results from a Phase 2 proof of concept trial of TC-5619 as a treatment for adults with attention deficit/hyperactivity disorder. In the trial, conducted in non-smokers, TC-5619 did not meet the primary efficacy outcome measure, change from baseline on the Conners' Adult ADHD Rating Scale-Investigator Rated Total ADHD Symptoms score after four, eight and 12 weeks of dosing. Targacept announced positive top-line results from a separate Phase 2 trial of TC-5619 in cognitive dysfunction in schizophrenia in January. Targacept announced positive top-line results from a separate Phase 2 trial of TC-5619 in cognitive dysfunction in schizophrenia (CDS) in January. TC-5619, a highly selective alpha7 neuronal nicotinic receptor modulator, is subject to license by Targacept's strategic collaborator AstraZeneca (AZN), with a decision expected in the second quarter of 2011
Targacept schizophrenia drug meets phase II goal
http://www.businessweek.com/ap/financialnews/D9KRHAJ80.htm
This might explain the recent strength.
There's something seriously happening here... the SP is trending up on no news. Someone knows something.
Is approval on the horizon?
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http://finance.yahoo.com/q/ks?s=TRGT
Targacept, Inc., a biopharmaceutical company, engages in the design, discovery, and development of drugs for the treatment of multiple diseases and disorders of the central nervous system. As of December 31, 2006, the company had four clinical-stage product candidates and three preclinical product candidates in its product portfolio. Its product candidates are in development as treatments for target indications in three therapeutic areas: cognitive impairment, depression and anxiety, and pain. The company principally offers Inversine, which is approved for marketing for the management of moderately severe to severe essential hypertension, a high blood pressure disorder. Its product candidates include TC-1734, a Phase II clinical trial completed product for the treatment of Alzheimer's disease, cognitive deficits in schizophrenia, and other conditions characterized by cognitive impairment, such as attention deficit hyperactivity disorder, age associated memory impairment, and mild cognitive impairment. Targacept's product candidates also include TC-2696 for acute post-operative pain; mecamylamine hydrochloride, the active ingredient in Inversine; and TC-5214, one of the enantiomers of mecamylamine hydrochloride; TC-2216, a phase I product for depression and anxiety disorders; and TC-5619 for various conditions, such as schizophrenia, cognitive impairment, and inflammation. The company has a collaborative research and license agreement with AstraZeneca AB for development and commercialization of TC-1734 to treat Alzheimer's disease, cognitive deficits in schizophrenia, and other cognitive disorders. Targacept was founded in 1997 and is based in Winston-Salem, North Carolina.
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