Trading FDA, Clinical Trial Binary Events: $AFFY $ALXA $INCY $PGNX

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

Affymax (NASDAQ:AFFY) and partner Takeda Pharma (OTC:TKPHY) reported that further analysis is ongoing for the previously reported pivotal PEARL and EMERALD studies of HEMATIDE (long-acting anemia drug) (peg-inesatide) for the treatment of chronic renal failure patients with anemia. The companies expect to discuss a potential registration strategy with the FDA by year-end 2010, which could lead to a New Drug Application (NDA) filing that seeks marketing clearance for the treatment of anemia in dialysis patients during 1H11.

Incyte (NASDAQ:INCY) expects to report top-line results from the pivotal COMFORT-I study of INCB18424 (oral formulation, JAK1/JAK2 Inhibitor) for myelofibrosis (MF), in December while full results from COMFORT-I & -II (EU study conducted by partner Novartis) are expected by mid-2011. In addition, INCY expects to begin the pivotal Phase 3 program for INCB18424 in the treatment of polycythemia vera (PV) during 4Q10.

Progenics Pharma (NASDAQ:PGNX) announced that a committee of the European Medicines Agency (EMA) issued a positive opinion for European marketing approval of a new pre-filled syringe (PFS) formulation of RELISTOR (methylnaltrexone). Last August, PGNX announced a sNDA filing with the FDA and a review is ongoing with anticipated US and EU market launches for the PFS formulation during 2Q11 pending regulatory approvals.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com — please visit his website to read the full articles, in addition to many other free tools and strategies related to binary event investing and trading…

Alexza Pharma (NASDAQ:ALXA) Dilution May Provide Excellent Entry Price for 10/11/10 Run-Up

Just as ALXA was starting to see some price action (up nearly 10% in the previous 4 trading days- including a market close at $3) this morning ALXA announced the typical pre-PDUFA “Bio-Dilution”.  This dip in price just as the run-up was taking shape may provide an excellent opportunity to get in at a low [...]

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Disclosure: Long ALXA