- On Tuesday the The FDA released briefing documents in connection with Spectrum Pharmaceutical Inc SPPI Application for poziotinib to treat patients with previously treated locally advanced or metastatic NSCLC.
- HC Wainwright says that while they were prepared for a contentious ODAC meeting, the questions and text in the ODAC briefing documents point to a more contentious meeting than expected.
- The analyst reiterates the buy recommendation, but lowers the price target from $12 to $9.
- “We understood that the side effect profile would be questioned at the 16 mg QD dose, but the focus on questioning efficacy raises some concerns,” the analyst writes.
- That recently accelerated approval from Daiichi Sankyo DSKNY–AstraZeneca Plc AZN Enhertu, with a 58% ORR and an mDOR of 8.7 months, also presents more headwinds for poziotinib, the analyst says.
- None of the other approved NSCLC therapies referenced in the briefing documents are specifically indicated for HER2 exon 20 insertion mutations.
- HC Wainwright lowered the probability of success for poziotinib from 70% to 50%. Think about getting approved on 11/24the analyst estimates the launch soon with sales of $2.2 million in 2022 and $328 million in 2026.
- Price promotion: SPPI shares are down 3.45% to $0.64 on the latest check Wednesday.
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