On Tuesday, the FDA released briefing documents related to Spectrum Pharmaceutical Inc’s SPPI application for poziotinib for treating patients with previously treated locally advanced or metastatic NSCLC.
HC Wainwright says that though they were ready for a contentious ODAC meeting, the questions and the text in the ODAC briefing documents suggest a more argumentative meeting than expected.
The analyst reiterates the Buy rating but cuts the price target from $12 to $9.
“We understood that the side effect profile at the 16mg QD dose would come into question, but the focus on questioning efficacy raises some concerns,” the analyst writes.
The recent accelerated approval of Daiichi SankyoDSKNY–AstraZeneca Plc’sAZN Enhertu with 58% ORR and an mDOR of 8.7 months also provides more headwinds for poziotinib, the analyst says.
None of the other approved NSCLC therapies referenced in the briefing documents specifically indicated for HER2 exon 20 insertion mutations.
HC Wainwright lowered the probability of success for poziotinib to 50% from 70%. Considering if the approval comes on November 24, the analyst estimates launch soon with sales of $2.2 million in 2022 and $328 million in 2026.
Price Action: SPPI shares are down 3.45% at $0.64 on the last check Wednesday.
