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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 (OTCQX: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.

Source: After FDA Approval, A New And Bigger Catalyst Looms Closer For Immunogen