Read Larry Connors' blog – Short Term Trading Strategies
The stock plummeted about 81%, plunging $1.11 to 25 cents a share by 11:10 am Eastern Time. Shares of the East Windsor, New Jersey-based company broke through support and hit a new low.
After the closing bell on Tuesday, NexMed revealed its decision not to file a New Drug Application with the FDA for the company's onychomycosis drug NM100060. The decision was taken on the basis of the first interpretable results of the phase III clinical studies on NM100060, which is a topical application of terbinafine formulated with NexACT.
NexMed noted that two of the NM100060 studies were designed to evaluate its efficacy, safety and tolerability in patients with mild to moderate toenail onychomycosis or nail fungus. Results from these randomized, double blind and placebo-controlled studies did not indicate any significant adverse event.
All the clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060 were assumed by Novartis AG (NVS | Quote | Chart | News | PowerRating) in 2005, under an exclusive, worldwide agreement with NexMed.
NexMed Chief Executive Officer Vivian Liu said, "While this is disappointing, European comparator study is still ongoing, and those results are expected mid 2009."
Earlier in August, NexMed announced that previously unpublished clinical data on Femprox, the company's topical treatment for female sexual arousal disorder, was published in the August 2008 issue of The Journal of Sexual Medicine.
The article, entitled "Efficacy and Safety of Alprostadil Cream for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Placebo-Controlled Study in Chinese Population," describes the results of NexMed's 400 patient take-home study completed in China in 2005.
In late July, NexMed said that the U.S. Food and Drug Administration, or FDA, rejected its New Drug Application for the experimental topical treatment for erectile dysfunction.
The company said the major regulatory issue raised by the FDA was related to a study performed on mice to test whether an experimental product is carcinogenic or not. The company completed the study in 2002.
Commenting on the FDA's response, Liu said, "While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency."
For comments and feedback: contact editorial@rttnews.com Copyright(c) 2008 RealTimeTraders.com, Inc. All Rights Reserved
More News:
Market Updates |
Stock Alerts |
All Trading News |
Stock Index
About TradingMarkets | Contact | Advertise | Careers | Link to Us | Site Map | Help | Terms & Conditions | Privacy Policy | Return Policy | Testimonials | Feedback
The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.
It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.
HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.
The Connors Group, Inc.
15260 Ventura Blvd., Ste. 2200
Sherman Oaks, CA 91403
© Copyright 2009 The Connors Group, Inc.
