I last covered Immunogen, this promising biotech stock, on February 13th, about two weeks prior to the PDUFA goal date on Trastuzumab's NDA for the HER2+ breast cancer indication. For those who aren't familiar with Immunogen's IMGN flagship drug, it's a combination of the same HER2-binding antibody that is used in a successful cancer drug known as Herceptin/Trastuzumab, and a special cancer-killing agent known as DM-1 developed by Immunogen.
This essentially combines a proven, effective "targeting system" with a new "cancer killer" that looks very promising. I think it's an exciting drug to watch, even as someone with no position in IMGN.
Immunogen finally received its FDA approval on February 22nd, 2013 - earlier than expected. Trastuzumab emtansine was also renamed to "Kadcyla", which was done to simplify the future commercialization efforts of Genentech/Roche (RHHBY) in the United States. For all intents and purposes, the drug is ready for its big launch this year.
Contrary to my own expectations, IMGN also tacked on an extra 13% in gains following announcement of the early FDA approval.
Also, this FDA approval was not really surprising to anyone following the stock. I also think that Kadcyla's current potential indication in post-Herceptin treatment of breast cancer is more than priced into the $1.36 billion market cap of IMGN, especially after this recent move. Remember that Immunogen is a partner of the company that will actually do the selling, and will only receive royalty payments.
Having said this, I think IMGN has substantial upside based on speculation over the phase III MARIANNE trial, which could result in first-line therapy indication for Kadcyla in HER2+ breast cancer. Basically, if this trial provides good enough results, it will form the basis for a sNDA filing that could multiply Kadcyla's market potential given FDA approval, making it a true blockbuster drug.
It's not set in stone when we will be getting initial results from the MARIANNE trial, but the company recently finished the enrollment process and gave us a ballpark estimate of late 2013 to early 2014. I'm personally excited to see how this trial goes, and I think investors should put more focus on it as we head closer to its completion. Financially speaking, this is the catalyst that can really ascend Immunogen as a company, and probably bring its share price out of its general $10-15 price range.
While Immunogen is not going to be a "10-bagger" anytime in the near future, I think that we could see the stock trending towards $20 by the end of the year, implying that shareholders may see 24% gains or more before we even get the results of MARIANNE.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.