Spectrum Pharmaceuticals, Inc.


SPPI

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

,

CanFite Biopharma Ltd


CANF

and

Catalent, Inc.


CTLT


,

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.

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