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Drug Co. Gets PDUFA Date for TKI

March 21, 2022 (Investorideas.com Newswire) “We expect poziotinib approval in late 2022 with sales of $21.9 million this year,” noted an H.C. Wainwright & Co. report.

Spectrum Pharmaceuticals Inc. (SPPI:NASDAQ) received a U.S. Food and Drug Administration (FDA) PDUFA date of Nov. 24 for poziotinib as a treatment for nonsmall cell lung cancer, reported H.C. Wainwright & Co. analyst Edward White in a March 18 research note.

Issuance of the PDUFA date follows Spectrum’s successful resubmission to the FDA of its new drug application for poziotinib and positive cohort 2 data from the ZENITH20 trial. Poziotinib is an oral, irreversible, tyrosine kinase inhibitor.

White relayed that the FDA asked Spectrum for further dosing information and indicated it was important to have substantial enrollment in a confirmatory trial at the time of approval. Thus, the biopharma commenced such a study.

“We expect poziotinib approval in late 2022 with sales of $21.9 million ($21.9M) this year and sales of $328M in 2026E,” White wrote.

Spectrum is on track to receive another PDUFA date, this one potentially in September, for eflapegrastim, a long-acting granulocyte colony stimulating factor, as a treatment for chemotherapy-induced neutropenia. The company recently resubmitted a related biologics license application to the FDA for review.

“We anticipate a launch for eflapegrastim in late 2022 with $5M in sales this year, growing to sales of $170M in 2026,” wrote White.

In other news, Spectrum presented, at ESMO’s Targeted Anticancer Therapies Congress on March 7, previously announced positive Cohort 4 data from the ZENITH trial. This group was comprised of firstline nonsmall cell lung cancer patients with HER2 exon-20 insertion mutations. Pursuing approval of eflapegrastim for this specific subpopulation would require a separate filing with the FDA.

Going forward, White noted, Spectrum intends to focus on “areas for greater potential commercial success, such as poziotinib in combination with KRAS inhibitors.”

As for its financial position, relayed White, Spectrum has sufficient funds for this year’s operations, according to its management. As of year-end 2021, the company had $100.6M in cash and marketable securities, and it received $20M from Hanmi in January.

H.C. Wainwright has a Buy rating and a $10 per share price target on Spectrum, the current share price of which is around $0.85.

Disclosures:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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Disclosures for H.C. Wainwright & Co., LLC, Spectrum Pharmaceuticals, Inc. (SPPI), March 18, 2022

I, Edward White , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Spectrum Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of February 28, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Spectrum Pharmaceuticals, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Spectrum Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Spectrum Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Spectrum Pharmaceuticals, Inc. during the past 12 months. The Firm does not make a market in Spectrum Pharmaceuticals, Inc. as of the date of this research report.

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