March is a catalyst-rich month for biotech and drug stocks.
In Europe, Endocyte (ECYT) and Merck (MRK) are expecting a decision on accelerated approval for their ovarian cancer therapy vintafolide following the CHMP meeting scheduled for March 17-20. The announcement decision will come no later than March 21.
Three significant FDA advisory committee meetings to look forward to later this month.
On March 26-27 the FDA's Molecular and Clinical Genetics Panel will review two non-invasive screening tests for colon cancer: Epigenomics' blood-based Epi proColon and Exact Sciences' (EXAS) stool-based Cologuard. Look for FDA briefing documents for Epigenomics on March 24 and Exact Sciences on March 25.
On March 31, the FDA's Anti-Infective Drugs Advisory Committee will review two new antibiotics: Cubist Pharmaceuticals' CBST tedizolid and Durata Therapeutics' (DRTX) dalbavancin. FDA briefing documents will be posted to the agency's web site on March 27.
On April 1, the Endocrinologic and Metabolic Drugs Advisory Committee will review MannKind's (MNKD) inhaled, rapid-acting insulin Afrezza. The Afrezza FDA panel counts as a March event because FDA briefing documents will be made available on March 28.
On the clinical side:
Top-line results from a phase II study of Insmed's (INSM) Arikace in lung disease caused by nontuberculous mycobacteria (NTM).
Top-line results from a phase II study of Endocyte and Merck's vintafolide in non-small lung cancer.