Novo Nordisk and Acorda Therapeutics took some hits today….

• First, Acorda received a refuse to file from the FDA stating that there were format issues with its Fampridine NDA application. During the morning conference call, CEO Ron Cohen fielded, and dodged, questions from analysts regarding the content of the FDA letter and potential setbacks. Cohen noted that while the FDA did not require additional clinical trials or data from Acorda, there was some pharmacokinetic data dating back to the Elan days that was of concern. Acorda must now re-file its NDA and though Cohen didn’t exactly say yes when asked by an analyst during the call, the drug’s PDUFA will obviously be pushed back from its original November 30, 2009 date. Cohen repeatedly stated that they had not read the letter in detail because it was just received yesterday and that the company wanted to meet with the FDA to discuss the issues before giving any additional guidance. The stock tanked a little bit and was down $4.61 (18.51%) to $20.29 at the time of this post. [Yahoo!Finance]

• Next, Novo hit a snag when the FDA said its diabetes drug liraglutide works, but that it had some concerns regarding cardiac safety. There was also some concerns regarding thyroid tumors (<—–BAD!!!). Also, it’s a big month for new diabetes drugs: Amylin, with partners with Eli Lilly and Alkermes, said its once-weekly injection of exenatide LAR was more effective than Merck’s Januvia and Takeda’s Actos in a 491-person study. Amylin was up $1.84 (16.3%) to $13.16. Novo Nordisk fell $2.02 (4%) to $48.28. [Yahoo!Finance]

Image from daleyblog

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