Key Developments: Targacept Inc (TRGT.OQ)
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Latest Key Developments (Source: Significant Developments)
Targacept Inc Announces Amendment To Its Collaboration With AstraZeneca
Targacept Inc announced that its collaboration with AstraZeneca has been restructured. Under the new terms:Targacept now has the right to pursue development and commercialization of any alpha7 NNR modulator in any therapeutic area, including cognitive disorders and schizophrenia, without obligation to AstraZeneca. Previously, AstraZeneca held an option to license any such compound that was developed by Targacept for a cognitive disorder or schizophrenia. Targacept has several alpha7 NNR modulators in its portfolio; AstraZeneca now has the right to develop and commercialize the alpha4beta2 NNR modulators that it has licensed from Targacept under the collaboration, including AZD1446, in any therapeutic area. Previously, AstraZeneca`s rights with regard to these compounds were limited to cognitive disorders and schizophrenia; AstraZeneca will return to Targacept all rights to the alpha4beta2 modulator TC-1734 (also known as AZD3480), which is currently in a Phase 2b clinical trial in mild to moderate Alzheimer`s disease. Full Article
Targacept Inc Issues FY 2013 Revenue Guidance Below Analysts' Estimates
Targacept Inc announced that for fiscal 2013, it expects operating revenues to be approximately $2.4 million. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $3.0 million for fiscal 2013. Full Article
Targacept Inc Appoints Stephen A. Hill As President And Chief Executive Officer
Targacept Inc announced that Stephen A. Hill has been appointed as President and Chief Executive Officer (CEO). Dr. Hill is expected to start with Targacept on December 1, 2012 and will also join Targacept`s Board of Directors. Full Article
Targacept Inc Raises FY 2012 Revenue Guidance
Targacept Inc announced that for fiscal 2012, it expects operating revenues to be approximately $58 million. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $59 million for fiscal 2012. Full Article
Targacept Inc Announces Plans To Develop TC-5214 In Overactive Bladder
Targacept Inc announced that it plans to pursue development of TC-5214 as a treatment for overactive bladder (OAB). Based on TC-5214’s unique pharmacokinetic profile, an analysis of data from a completed clinical program and findings from additional preclinical studies, the Company plans to initiate a Phase 2b study of TC-5214 in the first half of 2013. Completed clinical studies in approximately 2,400 subjects have resulted in a well-established safety and tolerability profile for TC-5214. Targacept’s analysis of data from that program, as well as additional preclinical studies, have revealed physiological findings believed to be consistent with marketed treatments for overactive bladder. In addition, prior studies have shown that over 90% of TC-5214 is eliminated unchanged through the bladder, supporting use of a low dose and creating the potential to minimize unwanted systemic effects. TC-5214 is a nicotinic channel modulator that has been found to act potently at nicotinic receptors located in the bladder. Agents that block the action of these receptors have been shown in animal models to decrease bladder wall contraction frequency and impact nerve signaling from the bladder. Similar effects in clinical trials in OAB would be expected to contribute to symptomatic improvement Full Article
Targacept Inc Reaffirms FY 2012 Revenue Guidance-Conference Call
Targacept Inc announced that net operating revenues of $50 million to $60 million is still the current guidance for fiscal 2012. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $58 million for fiscal 2012. Full Article
J. Donald deBethizy To Step Down As President And Chief Executive Officer Of Targacept, Inc.
Targacept, Inc. announced management changes that include the formation of an Office of the Chairman led by Mark Skaletsky, Chairman of Targacept's Board of Directors. The Office of the Chairman will assume the responsibilities of J. Donald deBethizy, who is stepping down as President and Chief Executive Officer and has resigned from Targacept's Board of Directors. Dr. deBethizy will assist in the transition, serving as special advisor to Mr. Skaletsky. A search for a new Chief Executive Officer will begin immediately. Full Article
Targacept, Inc. Reaffirms FY 2012 Net Operating Revenues Guidance
Targacept, Inc. announced that it continues to expect net operating revenues for fiscal 2012 to be in the range of $50 million to $60 million. This financial guidance includes both cash and non-cash revenue and expense items. Full Article
Targacept, Inc. Announces Top-Line Results From Two Exploratory Phase 2 Studies Of TC-6987
Targacept, Inc. announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes. In the asthma study, oral TC-6987 met protocol-defined success criteria (one-sided p < 0.1) on both co-primary outcome measures, change from baseline in forced expiratory volume for adjunct TC-6987 compared to adjunct placebo measured at two time points on day 28 (51ml and 58ml). In the type 2 diabetes study, the primary outcome measure, change in fasting plasma glucose, was not met, and Targacept will not pursue further development of TC-6987 as a treatment for diabetes. TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor (NNR) discovered by Targacept scientists using Pentad, the Company’s drug discovery platform. TC-6987 was generally well tolerated in both studies reported. There were no clinically meaningful changes in cardiovascular parameters in either study, an important finding that differentiates TC-6987 from many other alpha7 modulators. There were no treatment-emergent adverse events that led to discontinuation in the TC-6987 dose group in the asthma study and no clinically difference in the number of treatment-emergent adverse events that led to discontinuation between the TC-6987 and placebo dose groups in the type 2 diabetes study. Full Article
AstraZeneca PLC And Targacept, Inc. Announce Remaining TC-5214 Phase 3 Efficacy Studies Do Not Meet Primary Endpoint, Regulatory Filing Will Not Be Pursued
AstraZeneca PLC and Targacept, Inc. announced top-line results from the remaining Phase 3 studies investigating efficacy, tolerability and safety of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who did not respond adequately to initial antidepressant treatment. RENAISSANCE 4 and RENAISSANCE 5, both efficacy and tolerability studies, did not meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) total score after eight weeks of adjunct treatment with TC-5214 as compared to placebo. In both RENAISSANCE 4 and RENAISSANCE 5, as well as in the previously completed RENAISSANCE 2 and RENAISSANCE 3 studies, every dose group (TC-5214 and placebo) showed at least a 40 percent improvement in MADRS total score after eight weeks of adjunct treatment. TC-5214 was overall well tolerated in RENAISSANCE 4 and RENAISSANCE 5 with an adverse event profile generally consistent with prior clinical trials. In RENAISSANCE 7, a long-term study designed primarily to evaluate the safety of TC-5214, together with an antidepressant treatment, for one year, TC-5214 was overall well tolerated, with an adverse event profile generally consistent with prior clinical trials. These studies conclude the RENAISSANCE Program for TC-5214. Based on the totality of the results, AstraZeneca and Targacept will not pursue a regulatory filing for TC-5214 as an adjunct treatment for patients with MDD. Full Article

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