SPPI - Spectrum to face contentious AdCom meeting over cancer drug - H.C. Wainwright

H.C. Wainwright lowered the price target on the clinical-stage biotech Spectrum Pharmaceuticals ( NASDAQ: SPPI ) Wednesday, noting that the FDA staff documents on its lung cancer drug poziotinib suggested a more “argumentative” AdCom meeting ahead.

SPPI shares plunged ~37% Tuesday after the FDA published the briefing documents ahead of the agency’s Oncologic Drugs Advisory Committee meeting scheduled for Sep. 22.

“While we were ready for a contentious ODAC meeting, the questions and the text in the ODAC briefing documents suggest a more argumentative meeting than we had expected,” the analyst Edward White wrote.

While FDA reviewers pointed to concerns over the drug’s safety and delayed start of a confirmatory trial, the questions over poziotinib’s efficacy caused some raised eyebrows, White argued, lowering the price target of the stock to $9 from $12 per share.

With management noting an FDA requirement to complete a substantial enrollment for a confirmatory trial at the time of approval, the company still has time to enroll patients before Nov. 24 PDUFA date, according to White, who reiterates the Buy recommendation on SPPI.

In its recent earnings release, the company said that the confirmatory trial, required in the event of an accelerated approval for poziotinib, is expected to enroll patients with previously treated NSCLC harboring HER2 exon 20 mutations.

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