Tomorrow I'll be hanging out at the BioCentury/Thomson Reuters "Newsmakers in the Biotech Industry" conference in NYC, so I won't be able to monitor the webcast of an FDA panel meeting for a most intriguing drug.
I first blogged about it last Decemberwhen Pfizer struck the nearly half-a-billion dollar partnership deal with Auxilium on the product. It's called Xiaflex and it's for a condition known as Dupuytren's Contracture. In plain English, that's when fingers curve toward the palm. DataMonitor, which does industry research, estimates around five million people in the U.S. have it.
Tomorrow an FDA advisory committee will decide whether to recommend approval of the injectable Xiaflex. The stock skyrocketed yesterday when the agency's documents for the panel were posted on the web. Joseph Schwartz at Leerink Swann raised his price target from $35 to $40 on what he saw as the relatively benign briefing papers. LS makes a market in AUXL. But David Moskowitz at Caris & Company is keeping a "Sell" rating on the stock with an $18 target because he's "cautious" about Xiaflex's market potential.
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However, Xiaflex could be a two-in-one drug. Auxilium and Pfizer are first seeking approval of it for the debilitating finger problem. But, according to Moskowitz, later this year the companies are expected to unveil new mid-stage test results for a condition known as Peyronie's Disease. And that's really why I'm blogging about it...again. Peyronie's is curvature of the penis, which the International Journal of Impotence Research says strikes about one to two percent of the over-40 population. The publication also says people shouldn't confuse the problem with curvature from birth. Can't wait to see how the mainstream media handles this as Xiaflex for Peyronie's progresses toward FDA review.
But for now it's all about Dupuytren's. Look for a panel vote in the afternoon. Analysts expect AUXL shares to be halted for trading during the meeting.
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