Key Developments For Targacept, Inc.
Targacept, Inc. (TRGT.O) (Consolidated Issue listed on NASDAQ Global Market)
Targacept, Inc. Announces Data from Highly Successful Phase 2b Trial of TC-5214 as Augmentation Treatment for Major Depressive Disorder
Targacept, Inc. announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide. In the trial, the add-on TC-5214 arm (TC-5214 + citalopram) outperformed the add-on placebo arm (placebo + citalopram) on the primary outcome measure, the Hamilton Rating Scale for Depression-17, or HAM-D, and all of the secondary outcome measures, with high statistical significance. Selective serotonin reuptake inhibitors, or SSRIs, are the most commonly prescribed class of drugs for depression, but many patients do not respond well to SSRIs. The National Institute of Mental Health, or NIMH, has estimated that 14.8 million American adults suffer from MDD. In the NIMH’s large-scale Sequenced Treatment Alternatives to Relieve Depression, or STAR*D, study, approximately 63% of participants did not achieve remission following initial treatment with citalopram alone. In the TC-5214 trial, the magnitude of clinical response (change from double blind baseline after eight weeks) on HAM-D was 6.0 points greater for the add-on TC-5214 arm (13.75 point improvement) than for the add-on placebo arm (7.75 point improvement). This result was highly statistically significant (p < 0.0001) on an intent to treat basis.
Targacept, Inc. Announces Pricing Of Common Stock Offering
Targacept, Inc. announced that the recently announced underwritten public offering of 2,200,000 shares of its common stock has been priced at a price to the public of $21.00 per share. As previously announced, Deutsche Bank Securities will act as sole manager for the offering and Targacept has granted Deutsche Bank Securities an option to purchase an additional 320,000 shares of common stock to cover over-allotments, if any.
Targacept, Inc. Announces Common Stock Offering
Targacept, Inc. announced the pricing of an underwritten public offering of 2,200,000 shares of its common stock. Deutsche Bank Securities will act as sole manager for the offering. Targacept has granted Deutsche Bank Securities an option to purchase an additional 320,000 shares of common stock to cover over-allotments, if any.
Targacept, Inc. Updates FY 2009 Revenue Guidance
Targacept, Inc. updated its fiscal 2009 guidance and expects net operating revenues to be in the range of $22-$23 million. According to Reuters Estimates, analysts are expecting the Company to report revenues of $19 million for the same period.
Targacept, Inc.'TC-5214 Achieves All Primary And Secondary Outcome Measures In Phase 2b Trial As Augmentation Treatment For Major Depressive Disorder
Targacept, Inc. announced positive top-line results from a double blind, placebo controlled, flexible dose Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment for major depressive disorder, or MDD, in subjects who did not respond adequately to first-line treatment with citalopram alone. The result on the primary outcome measure for the trial, mean change between treatment (TC-5214 + citalopram) and placebo (placebo + citalopram) from baseline on the Hamilton Rating Scale for Depression-17, or HAM-D, was highly statistically significant in favor of TC-5214 (p < 0.0001) on an intent to treat basis. The results on all of the trial`s secondary efficacy measures, including assessments of depression, irritability, disability, cognition, severity of illness and global improvement, were also highly statistically significant in favor of TC-5214 on an intent to treat basis. TC-5214 exhibited a favorable tolerability profile in the trial. The most frequent adverse events were headache, dizziness and constipation. There was no clinically significant difference between the dose groups in discontinuations due to adverse events. There was one serious adverse event in the trial considered by the investigators to be related to study drug (citalopram and/or TC-5214), a seizure experienced by a study subject.
