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Spectrum (SPPI) Down as FDA Panel Votes Against NSCLC Drug
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Shares of Spectrum Pharmaceuticals, Inc. were down 32.6% on Friday after the company announced that the FDA's Oncologic Drugs Advisory Committee (“ODAC”) did not vote in favor of its pipeline candidate, poziotinib, for the treatment of advanced or metastatic non-small cell lung cancer (“NSCLC”) in previously treated patients with HER2 exon 20 mutations on Sep 22.
The ODAC voted nine to four, thus confirming that the current benefits of poziotinib did not outweigh its risks.
SPPI submitted a new drug application (“NDA”) to the FDA for poziotinib back in December 2021 for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.
The FDA accepted the NDA for poziotinib earlier in 2022, and a decision from the regulatory body is expected on Nov 24, 2022.
Though the FDA is not completely bound by the ODAC’s recommendations, it usually follows the same.
Shares of Spectrum have plunged 66.3% in the year-to-date period compared with the industry’s decline of 29.2%.
Image Source: Zacks Investment Research
Poziotinib is an irreversible tyrosine kinase inhibitor being evaluated for NSCLC tumors with various mutations.
The company has an exclusive license from the South Korean company, Hanmi Pharmaceutical, to develop and commercialize poziotinib all over the world, excluding Korea and China.
Both Spectrum and Hanmi are currently evaluating poziotinib in several mid-stage studies targeting various solid tumor indications.
The FDA has already granted poziotinib a Fast Track designation for the treatment of advanced or metastatic NSCLC in previously treated patients with HER2 exon 20 mutations. To date, no treatment has been approved by the FDA specifically for the aforementioned indication.
Hence, if successfully developed and upon potential approval, poziotinib can serve an area of unmet medical need and drive growth for the company.
Infinity Pharmaceuticals’ loss per share estimates narrowed 11.5% for 2022 and 13.3% for 2023 in the past 60 days.
Earnings of Infinity Pharmaceuticals have surpassed estimates in each of the trailing four quarters. INFI delivered an earnings surprise of 7.14%, on average.
Phio Pharmaceuticals’ earnings per share estimates have increased 40.4% for 2022 and 13% for 2023 in the past 60 days.
Earnings of Phio Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. PHIO delivered an earnings surprise of 21.32%, on average.
Calithera Biosciences’ loss per share estimates have narrowed 37.3% for 2022 and 39.8% for 2023 in the past 60 days.
Earnings of Calithera Biosciences surpassed estimates in three of the trailing four quarters and missed on the other occasion. CALA delivered an earnings surprise of 21.08%, on average.
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Spectrum (SPPI) Down as FDA Panel Votes Against NSCLC Drug
Shares of Spectrum Pharmaceuticals, Inc. were down 32.6% on Friday after the company announced that the FDA's Oncologic Drugs Advisory Committee (“ODAC”) did not vote in favor of its pipeline candidate, poziotinib, for the treatment of advanced or metastatic non-small cell lung cancer (“NSCLC”) in previously treated patients with HER2 exon 20 mutations on Sep 22.
The ODAC voted nine to four, thus confirming that the current benefits of poziotinib did not outweigh its risks.
SPPI submitted a new drug application (“NDA”) to the FDA for poziotinib back in December 2021 for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.
The FDA accepted the NDA for poziotinib earlier in 2022, and a decision from the regulatory body is expected on Nov 24, 2022.
Though the FDA is not completely bound by the ODAC’s recommendations, it usually follows the same.
Shares of Spectrum have plunged 66.3% in the year-to-date period compared with the industry’s decline of 29.2%.
Image Source: Zacks Investment Research
Poziotinib is an irreversible tyrosine kinase inhibitor being evaluated for NSCLC tumors with various mutations.
The company has an exclusive license from the South Korean company, Hanmi Pharmaceutical, to develop and commercialize poziotinib all over the world, excluding Korea and China.
Both Spectrum and Hanmi are currently evaluating poziotinib in several mid-stage studies targeting various solid tumor indications.
The FDA has already granted poziotinib a Fast Track designation for the treatment of advanced or metastatic NSCLC in previously treated patients with HER2 exon 20 mutations. To date, no treatment has been approved by the FDA specifically for the aforementioned indication.
Hence, if successfully developed and upon potential approval, poziotinib can serve an area of unmet medical need and drive growth for the company.
Zacks Rank & Stocks to Consider
Spectrum currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Infinity Pharmaceuticals, Inc. , Phio Pharmaceuticals Corp. (PHIO - Free Report) and Calithera Biosciences, Inc. (CALA - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Infinity Pharmaceuticals’ loss per share estimates narrowed 11.5% for 2022 and 13.3% for 2023 in the past 60 days.
Earnings of Infinity Pharmaceuticals have surpassed estimates in each of the trailing four quarters. INFI delivered an earnings surprise of 7.14%, on average.
Phio Pharmaceuticals’ earnings per share estimates have increased 40.4% for 2022 and 13% for 2023 in the past 60 days.
Earnings of Phio Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. PHIO delivered an earnings surprise of 21.32%, on average.
Calithera Biosciences’ loss per share estimates have narrowed 37.3% for 2022 and 39.8% for 2023 in the past 60 days.
Earnings of Calithera Biosciences surpassed estimates in three of the trailing four quarters and missed on the other occasion. CALA delivered an earnings surprise of 21.08%, on average.