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With Upcoming Contentious Meeting, This Analyst Cuts Price Target On Spectrum Pharma

With Upcoming Contentious Meeting, This Analyst Cuts Price Target On Spectrum Pharma

隨着爭議會議即將到來，這位分析師下調了Spectrum Pharma的目標股價
Benzinga Real-time News ·  2022/09/21 14:21
  • On Tuesday, the FDA released briefing documents related to Spectrum Pharmaceutical Inc's (NASDAQ: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 Sankyo (OTC:DSKNY)-AstraZeneca Plc's (NASDAQ: AZN) 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.
  • 美國食品藥品管理局週二發佈了與Spectrum Pharmaceutical Inc（納斯達克股票代碼：SPPI）申請波齊奧替尼治療先前接受過局部晚期或轉移性非小細胞肺癌治療患者相關的簡報文件。
  • HC Wainwright說，儘管他們已經爲有爭議的ODAC會議做好了準備，但ODAC簡報文件中的問題和案文表明，這次會議的爭論性比預期的要多。
  • 分析師重申了買入評級，但將目標股價從12美元下調至9美元。
  • 分析師寫道：“我們知道16mg QD劑量的副作用會受到質疑，但是對療效的質疑引起了一些擔憂。”
  • 該分析師表示，第一三共集團（場外交易代碼：DSKNY）——阿斯利康集團（納斯達克股票代碼：AZN）Enhertu最近加速獲得批准，其OR率爲58％，mDor爲8.7個月，這也爲波齊奧替尼帶來了更多不利因素。
  • 簡報文件中提及的其他經批准的非小細胞肺癌療法均未特別針對HER2外顯子20插入突變。
  • HC Wainwright將波齊奧替尼的成功概率從70％降至50％。考慮到是否在11月24日獲得批准，分析師估計很快就會推出，2022年的銷售額爲220萬美元，2026年的銷售額爲3.28億美元。
  • 價格走勢：在週三的最後一次支票中，SPPI股價下跌3.45％，至0.64美元。
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