Ebb & Flow

A big week for FDA panel reviews will provide a major test for the biotech space in the wake of last week's post-Labor Day let-down.

The big newsmakers will be Tuesday's Oncologic Drugs Advisory Committee review of the BLA for Idec's Zevalin ibritumomab radiolabeled antibody to treat non-Hodgkin's lymphoma (NHL) and follicular NHL refractory to IDPH's Rituxan, followed on Wednesday by the Anti-Infective Drugs Advisory Committee discussion of Eli Lilly's Xigris sepsis biologic.

Both reviews will be watershed events for the categories, as the difficult course for radiolabeled antibodies and sepsis treatments both are well-chronicled. And even though Xigris is not a biotech company drug, both meetings may be taken as major litmus tests by investors who increasingly believe that the leaderless FDA has become a major drag on the industry.

Matrix's FDA review posted Friday portended a rough start of the ODAC agenda today. MATX lost $0.90 (12%) to $6.79 through Thursday prior to its trading halt on Friday, when the FDA released its medical review of the NDA for IntraDose cisplatin/epinephrine injectable gel to treat head and neck cancer, which recommended against approval (see BioCentury Extra, Friday Sept. 7).

Guilford (GLFD) also will be in front of ODAC, which on Tuesday will consider the sNDA for GLFD's Gliadel wafer as a first line therapy for malignant glioma. Gliadel is approved to treat recurrent glioblastoma multiforme. The stock was off $1.10 to $10.95 last week.

Front-running sellers also pushed IDPH down $1.66 to $57.61 on the week.


Last week's NewsMakers in the Biotech Industry investor conference provided mixed messages for the sector, with record numbers of investors crowding into company presentations while outside the venue the equity markets were taking a bath.

By Ebb & Flow's tally, at least three presenting companies - Cubist (CBST), Dendreon (DNDN) and Interneuron (IPIC) - announced completion of patient enrollment in their Phase

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