Amylin (AMLN) Skyrockets on EU Recommendation of Bydureon

After an EU regulatory panel recommended Amylin's (NASDAQ:AMLN) diabetes drug Bydureon to be approved, shares of the company soared by about 13 percent.

This follows a disappointing refusal from the U.S. Food and Drug Administration in the latter part of 2010, which said it needed more information on the drug before it would recommend it for approval.

The three companies will said today they'll supply additional information to the FDA in the second half of 2011.

Shares of Alkermes (NASDAQ:ALKS), which developed the delivery system for Bydureon, were also hopping today.

Alkermes was trading at $13.95, gaining $0.54, or 4.03 percent, as of 12:27 PM EDT. Amylin was at $12.71, rising $1.45, or 12.88 percent. Eli Lilly, also a partner in the drug, was trading at $36.02, up $0.27, or 0.76 percent.

Why Amylin Pharmaceuticals (AMLN), Kendle International (KNDL), Sigma Designs (SIGM) Got Crushed Last Week

Amylin Pharmaceuticals (Nasdaq:AMLN), Kendle International (Nasdaq:KNDL) and Sigma Designs (Nasdaq:SIGM) got hammered last week, falling from 13.07 percent to 25.38 percent in one day.

This is an all too familiar and distasteful feeling for investors in Amylin Pharmaceuticals. Back in October, they got crushed when Amylin lost almost half its market value after the FDA rejected its diabetes drug Bydureon, saying the drug needed more testing.

So yesterday, Amylin and partners Eli Lilly (NYSE:LLY) and Alkermes announced results from a new clinical trial against Novo Nordisk's (NYSE:NVO) Victoza (which weren't part of the regulatory process) and came up short. Apparently, way short. While the pharmaceutical still plans to resubmit its application to market Bydureon for the third time, investors aren't waiting around again.

Clinical research organization Kendle International sold off sharply yesterday over the big fourth-quarter loss it reported, reversing a year-ago profit, and it's down another 11% this morning.

Sigma's on board with Motorola Mobility (MMI), Cisco (Nasdaq:CSCO), and others, and Sigma-based boxes for IPTV solutions are expanding. There's no reason to think Sigma Designs won't be laughing at this plunge later.






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Amylin Pharmaceuticals (NASDAQ:AMLN) Getting Rough Treatment from Regulatory Delays

Jefferies (NYSE:JEF) says they believe Amylin Pharmaceuticals (NASDAQ:AMLN) is being overly punished by the Street, based on prior regulatory delays.

Amylin did recently announce they were cleared to go forward with their Bydureon QT study, which will launch in February, and will be refiled some time in the second half of 2011.

Jefferies says the are positive on Amylin in the long term, and increased their full year 2011 and full year 2012 estimates on them from $0.73 and $1.04 to $0.66 and $0.59.

They reiterate their "Buy" rating on Amylin Pharmaceuticals (AMLN), which was trading at $16.24, gaining $0.97, or 6.35 percent, as of 2:15 PM EST. Jefferies boosted their price target on Amylin from $26 to $29.

Amylin Pharmaceuticals (NASDAQ:AMLN) Awaits TQT Protocol Review

As Amylin Pharmaceuticals (NASDAQ:AMLN) waits for a review of a TQT protocol submission, Barclays feels there will be risks to higher doses being required.

Barclays says, "We are maintaining our rating on shares of AMLN following an update with management and on further consideration of TQT trial requirements. With a TQT protocol submission yet to be reviewed by FDA we believe that the proposed exenatide concentration range falls below conditions of maximal inhibition and may need to be pushed higher to satisfy FDA. In the near term, we see increased risk to Byetta share erosion and with BYDUREON approval unlikely before mid-2012 would advise a wait-and-see approach to AMLN shares."

"...With primary focus on BYDUREON and the recent complete response letter (CRL) it would seem that AMLN has submitted a thorough QT (TQT) study protocol to FDA but has yet to meet with the agency. We believe that AMLN is targeting exenatide blood levels up to 500pg/ml with company suggesting no reason to go beyond 2x therapeutic levels. With Byetta blood levels increased 3.37x in ESRD patients, however, and with higher CMax with BYDUREON we see risk to higher doses being required."

Barclays reiterates an "Equalweight" rating on Amylin Pharmaceuticals, which closed Tuesday at $15.02, gaining $0.42, or 2.88 percent. Barclays has a price target of $12 on the company.