This Week in Biotech: Part 1

With the SPDR S&P Biotech Index up 27% year to date, it's very evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.

To say this was a busy week in biotech would be a monstrous understatement. In fact, there were so many studies out this week that I've broken down this weekly wrap-up into two separate articles for sheer number newsworthy stories. In this article I plan to note this week's upside surprises.

If you recall, heading into this week I recommended that investors keep an eye on both Novartis (NYSE: NVS  ) and Novo Nordisk (NYSE: NVO  ) , as they were both expected to head before the FDA panel this week -- and neither disappointed.

Novartis' Signifor, a treatment for Cushing's disease that's already approved in Europe, received a unanimous 10-0 vote in recommendation of approval from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee this week. Cushing's Disease patients have few treatment options available at the moment, and more than one-quarter of the 162 patients treated in its late-stage study using Signifor demonstrated lower urinary free cortisol levels after six months at high dosage.

Without calling it a sure thing, I'd say Signifor looks poised for FDA approval. That's bad news for Corcept Therapeutics (Nasdaq: CORT  ) , which nosedived this week and was downgraded to underperform by Piper Jaffray since its competing drug, Korlym, is now set to face increased competition from Signifor.

Novo Nordisk didn't enjoy a unanimous decision for its drug which went before the FDA panel on Thursday, but it nonetheless received optimistic news. The FDA panel, by an 8-4 vote, recommended approval of Novo Nordisk's long-lasting insulin drug, degludec, but it did recommend the company conduct additional safety tests, specifically because of concerns about heart attacks and strokes. While noting these safety concerns, most panel members think those concerns shouldn't hold up marketing of the product assuming FDA approval. 

BioMarin Pharmaceutical (Nasdaq: BMRN  ) had an exceptional week, rising 29% in total, after a phase 3 clinical trial for experimental drug GALNS met its primary endpoint in treating Morquio A Syndrome, or MPS IVA. A weekly dose of the drug allowed patients affected by MPS IVA to increase their walking distance by 22.5 meters over the placebo. According to research firm Cowen and Co., approximately 3,000 people are affected by MPS IVA worldwide, which could represent a $500 million to $800 million opportunity. My Foolish colleague Brian Pacampara thinks biotech's savviest investors should keep their eyes closely on BioMarin moving forward.

Finally, rounding out the week on a high note was Sequenom (Nasdaq: SQNM  ) , which reported less-than-stellar third-quarter results headlined by a $0.03 EPS miss but also noted a big improvement in its maternal Down syndrome tests handled. According to Sequenom, the company was handling 1,700 MarternT21 samples per week at the end of October and appears on pace to crush its previous forecast of 50,000 billed tests in 2012. It appears that investors finally have something to cheer about.

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