Investopedia: Seattle Genetics - And Now The Hard Bit

This has been a tough year for biotechs. Compounding a lull in clinical news, the FDA continues to play a "catch me if you can" game of changing standards for approval. On top of that, pharmaceutical companies like Pfizer (NYSE:PFE) and Merck (NYSE:MRK) have shown relatively little interest in making major acquisitions without approved products in hand. In addition, independents like Dendreon (Nasdaq:DNDN) have shown that FDA approval is only one battle in the larger war.



With all of that in mind, then, how excited should investors be over word last last week that the FDA has approved Seattle Genetics' (Nasdaq:SGEN) Adcetris? Clearly this is good news (far better than a rejection, at least), and the FDA was rather lenient with the labeling. Still, investors should be cautious as post-approval can be a challenging time to own biotechnology stocks.

The FDA Roars, but Ultimately Says Yes
The FDA gave a thorough work-over to Seattle Genetics during the company's panel meeting, seeming to make it abundantly clear that the agency had issues with the company's application to sell Adcetris for relapsed/refractory Hodgkin's lymphoma, let alone another indication for anaplastic large cell lymphoma.

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