This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

AstraZeneca And Targacept Announce Remaining TC-5214 Phase 3 Efficacy Studies Do Not Meet Primary Endpoint, Regulatory Filing Will Not Be Pursued

AstraZeneca and Targacept, Inc. today 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.

“Since the readout from the first RENAISSANCE Program outcomes, we have been carefully scrutinizing all aspects of our business to prepare for this contingency, and we will announce our plans by the end of April,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “Targacept has built a deep and mechanistically diverse clinical pipeline, and, with multiple NNR Therapeutics in Phase 2 development in areas of large medical need and commercial opportunity and over $225 million in cash, we are well positioned for future success.”

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,038.80 -41.34 -0.23%
S&P 500 2,112.95 -4.74 -0.22%
NASDAQ 5,063.6340 -28.4510 -0.56%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs