logo
  Join        Login             Stock Quote

AMAG Pharma (NASDAQ:AMAG): Bounce?

 December 23, 2008 09:00 AM
 


We have several firms out defending AMAG Pharma (NASDAQ:AMAG) this morning follwing news the FDA issued a Complete Response Letter for Ferumoxytol:

- Leerink says they are encouraged that two of the three issues in the original Complete Response Letter from late October appear to have been resolved without the need for additional clinical trials, and they would be buyers on any weakness, as this removes the worst case scenario, in firm's view. Reits Outperform and $46 tgt.

- JP Morgan reits Overweight on AMAG saying they expect weakness in AMAG shares as investors question the management's ability to effectively address regulatory questions, but they believe that ferumoxytol (trade name now Feraheme) will be approved without additional clinical trils. Remain Overweight on expectations of a brief delay (6- mo or less), which in their view would drive significant upside in AMAG shares.

A longer delay doesn't seem likely. The ferumoxytol saga looks a lot to them like Vyvanse story, where Shire gained FDA approval after 2 CR letters, where both resubmissions were designated Class 1 (2-mo review). Unresolved label conflicts apparently was the basis of the 1st CR, while manufacturing questions underpinned the 2nd CR, and the entire approval delay was less than 6 months. Firm believes ferumoxytol could follow a similar path, with approval by mid-09. Note that a longer delay (2H09 or later) could start to impact valuation, since we believe IV iron sales growth could moderate in a bundled environment (likely phase-in begins by 2011e).

Notablecalls: AMAG will hold a conf call 8:30 AM ET to clarify the issues behind the 2nd CR Letter. I really like JPM's reasoning re: Vyvance

I suspect there will be several firms out in defense of AMAG today.

The stock will take a hit but it shouldn't be more than say 10% putting it above the $30 level in my book. This makes the $27-$28 levels a buy
iOnTheMarket Premium
Advertisement

Advertisement


Comments Closed


rss feed

Latest Stories

article imageHow the Chinese Slowdown Will Impact Your Investments

Most countries would find a quarterly growth rate of 7.3% a cause for a read on...

article imageHow To Profit From Foreign Investment In Real Estate

Though investors don't always capitalize on it, history has a way of repeating itself. In fact, when I saw read on...

article imageAnother Round Of Upbeat US Macro Reports

The US economy grew faster than expected in this year’s third quarter, according to this morning’s read on...

article imageDistinguishing The Fed's Securities Purchases From Monetary Expansion

There has been a bit of confusion about what today's FOMC announcement means with respect to Quantitative read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.