May Catalysts for Biotech and Drug Stocks

By Brett Chase After a few months of blockbuster Food and Drug Administration advisory panel meetings, May seems a bit calmer. But there are certainly important dates for drug and biotechnolgy companies. Here are some events to watch for this month. Dates are subject to change. May 3

Vertex Pharmaceuticals (VRTX), which saw its experimental hepatitis C drug telaprevir endorsed by an FDA panel last week, will report first-quarter results and hold a conference call after market Tuesday. Vertex is expecting an FDA decision later this month on telaprevir approval. (See Has Vertex Peaked?) (To view Selfish Investing's analysis on preserving silver profits, click here.) Merck (MRK) also won unanimous support from an FDA advisory panel that recommended the company's hepatitis C treatment boceprevir should be approved for sale in the US. Merck has only said it expects an FDA ruling by mid-May. Merck and Vertex will battle for market share if both their hepatitis C treatments are approved. Vertex is expected to grab most of the market for these new treatments. (See Moment of Truth for Vertex's Hepatitis C Treatment.) May 4

MannKind (MNKD) will meet with FDA officials about what the company would need to do to win approval of the Afrezza insulin inhaler for diabetics. The product has been rejected twice by the agency, most recently in January. (See Mannkind's Giant Misstep.) This meeting was rescheduled from last month. (To read Carol Kopp's article on reactions to Osama's death in the Muslim community, click here.) May 18

Scientific abstracts are released in advance of the largest cancer conference of the year, the annual meeting of the American Society of Clinical Oncology. The abstracts will be released at 6 p.m. (New York time) on ASCO's website. May 19

An FDA panel of expert advisers will discuss the safety of Abbott Laboratories' (ABT) cholesterol drug Trilipix. The drug was approved by the FDA in December 2008. (To view Erik Swarts' piece on steep downside market moves, click here.) May 23

Vertex expects word from the FDA on approval of telaprevir hepatitis C drug. May 30

The FDA is expected to make a decision on whether to approve Optimer Pharmaceuticals' (OPTR) antibiotic fidaxomicin. Optimer already signed a pact with Cubist Pharmaceuticals (CBST) following an FDA advisory panel's endorsement of the drug. (See Optimer Readies Launch Before Drug Is Approved.) To read the rest, head over to Minyanville.