Trading Off of the FDA

by: Mike Havrilla

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

Cell Therapeutics (NASDAQ:CTIC) announced a five-year clinical and commercial supply agreement with NerPharMa for pixantrone, and the Company plans to submit a Marketing Authorization Application (MAA) in Europe while initiating a Phase 3 study in the US in patients with relapsed or refractory aggressive non-Hodgkins lymphoma (NHL) by year-end 2010.

ChemGenex Pharma (OTC:CXSPY) expects to submit combined data for OMAPRO (omacetaxine)from two completed pivotal studies to the FDA by year-end 2010 as part of a New Drug Application (NDA) seeking approval for the third-line treatment of patients with chronic myeloid leukemia (CML) (regardless of mutation status) while the Company expects a European approval (MAA) decision expected during 1Q11.

ISTA Pharma (ISTA) initiated a clinical trial to evaluate Bepotastine Besilate Nasal Spray for the treatment of symptoms associated with seasonal allergic rhinitis. ISTA will study three doses of the nasal spray given twice daily and expects to complete the study and report preliminary results this fall.

KV Pharmaceutical (KV.A) announced yesterday that Hologic (NASDAQ:HOLX) filed a resubmission to a January 2009 FDA request for additional information to support the NDA for GESTIVA (17P or hydroxyprogesterone caproate injection), seeking marketing clearance for the prevention of preterm births in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past. Earlier this year in January, KV amended its asset purchase agreement with HOLX to secure the global rights to GESTIVA, which is contingent on receiving FDA approval.

Disclosure: No positions