We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Spectrum's (SPPI) NSCLC Drug Gets FDA's Fast Track Designation
Read MoreHide Full Article
Spectrum Pharmaceuticals, Inc. announced that the FDA has granted a Fast Track designation to its pipeline candidate, poziotinib, which is being developed for the treatment of non-small cell lung cancer (“NSCLC”) in previously treated patients with HER2 exon 20 mutations.
The company plans to submit a new drug application (“NDA”) for poziotinib for the given indication later in 2021.
Shares of Spectrum Pharmaceuticals were up 18.8% following the announcement of the news on Thursday. In fact, the stock has rallied 14.7% so far this year against the industry’s decrease of 0.7%.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions. Another potential benefit of the Fast Track tag is priority review, which lowers the standard review period of an NDA from 10 months to six.
We note that poziotinib, a novel irreversible tyrosine kinase inhibitor, is currently being developed for NSCLC tumors with various mutations. Currently, no approved therapy to treat patients with HER2 exon 20 mutations exists. The candidate is being evaluated in a multi-cohort phase II study — ZENITH20– for treating NSCLC patients.
Hence, if successfully developed and upon potential approval, poziotinib can serve an area of unmet medical need and drive growth for the company.
Apart from poziotinib, Spectrum Pharmaceuticals’ another pipeline candidate is Rolontis, which is being developed for the treatment of breast cancer.
Please note that Rolontis is under review in the United States. In December 2019, the FDA accepted the biologics license application (“BLA”) seeking approval for Rolontis for the management of chemotherapy-induced neutropenia. A decision was expected by Oct 24, 2020.
However, in the third quarter of 2020, the FDA deferred its action on the BLA for Rolontis due to the restrictions on travel owing to the COVID-19 pandemic. Per the company, the deferral is not a Complete Response Letter from the FDA.
Catalyst Pharmaceuticals’ earnings estimates have been revised 5.6% upward for 2021 over the past 60 days. The stock has rallied 12.9% year to date.
CanFite Biopharma’s loss per share estimates have narrowed 21.7% for 2021 over the past 60 days. The stock has increased 13.5% year to date.
Catalent’s earnings estimates have been revised 10.1% upward for 2021 over the past 60 days. The stock has inched up 2.1% year to date.
5G Revolution: 3 Stocks to Make Your Move
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Image: Bigstock
Spectrum's (SPPI) NSCLC Drug Gets FDA's Fast Track Designation
Spectrum Pharmaceuticals, Inc. announced that the FDA has granted a Fast Track designation to its pipeline candidate, poziotinib, which is being developed for the treatment of non-small cell lung cancer (“NSCLC”) in previously treated patients with HER2 exon 20 mutations.
The company plans to submit a new drug application (“NDA”) for poziotinib for the given indication later in 2021.
Shares of Spectrum Pharmaceuticals were up 18.8% following the announcement of the news on Thursday. In fact, the stock has rallied 14.7% so far this year against the industry’s decrease of 0.7%.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions. Another potential benefit of the Fast Track tag is priority review, which lowers the standard review period of an NDA from 10 months to six.
We note that poziotinib, a novel irreversible tyrosine kinase inhibitor, is currently being developed for NSCLC tumors with various mutations. Currently, no approved therapy to treat patients with HER2 exon 20 mutations exists. The candidate is being evaluated in a multi-cohort phase II study — ZENITH20– for treating NSCLC patients.
Hence, if successfully developed and upon potential approval, poziotinib can serve an area of unmet medical need and drive growth for the company.
Apart from poziotinib, Spectrum Pharmaceuticals’ another pipeline candidate is Rolontis, which is being developed for the treatment of breast cancer.
Please note that Rolontis is under review in the United States. In December 2019, the FDA accepted the biologics license application (“BLA”) seeking approval for Rolontis for the management of chemotherapy-induced neutropenia. A decision was expected by Oct 24, 2020.
However, in the third quarter of 2020, the FDA deferred its action on the BLA for Rolontis due to the restrictions on travel owing to the COVID-19 pandemic. Per the company, the deferral is not a Complete Response Letter from the FDA.
Zacks Rank & Stocks to Consider
Spectrum Pharmaceuticals currently carries a Zack Rank #3 (Hold). Better-ranked stocks in the biotech sector include Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) , CanFite Biopharma Ltd (CANF - Free Report) and Catalent, Inc. (CTLT - 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.
Catalyst Pharmaceuticals’ earnings estimates have been revised 5.6% upward for 2021 over the past 60 days. The stock has rallied 12.9% year to date.
CanFite Biopharma’s loss per share estimates have narrowed 21.7% for 2021 over the past 60 days. The stock has increased 13.5% year to date.
Catalent’s earnings estimates have been revised 10.1% upward for 2021 over the past 60 days. The stock has inched up 2.1% year to date.
5G Revolution: 3 Stocks to Make Your Move
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Download now. Today the report is FREE >>