Kaplan Fox Continues to Investigate Potential Securities Fraud at Spectrum Pharmaceuticals, ...

NEW YORK, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP ( www.kaplanfox.com ) is continuing to investigate claims on behalf of investors in Spectrum Pharmaceuticals, Inc. (“Spectrum” or the “Company”) (NASDAQ: SPPI) securities.

If you purchased Spectrum securities and would like to discuss our investigation, please contact us by emailing jcampisi@kaplanfox.com or by calling (212) 329-8571.

On November 25, 2022, the Company disclosed that it “has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Spectrum’s New Drug Application (NDA) for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer ("NSCLC") harboring HER2 exon 20 insertion mutations. The FDA issued a CRL indicating the poziotinib application cannot be approved in its present form. Based on the CRL, the Company would have to generate additional data including a randomized controlled study prior to approval.”

“While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed.”

According to Reuter s, the Company will cut 75% of its research and development workforce and focus on its other cancer drug, Rolvedon.

Previously, on September 22, 2022, Reuters reported that advisers to the U.S Food and Drug Administration “voted against recommending Spectrum Pharmaceuticals’  (SPPI.O)  experimental drug for the treatment of patients with a form of non-small cell lung cancer. The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing marginal efficacy, high level of toxicities, and lack of dose optimization. The panel's decision was in-line with   briefing documents released by the drug regulator on Tuesday that raised concerns over the efficacy of the treatment compared with existing drugs like Daiichi Sankyo’s  (4568.T)  and AstraZeneca’s Enhertu.  read more ”

Following this news, Spectrum’s stock price declined from a closing price on September 22, 2022 of $0.63 per share, to close at $0.43 per share, a decline of over 31% per share on heavy volume.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

WHY CONTACT KAPLAN FOX - Kaplan Fox is a leading national law firm focusing on complex litigation with offices in New York, Oakland, Los Angeles, Chicago and New Jersey. With over 50 years of experience in securities litigation, Kaplan Fox offers the professional experience and track record that clients demand. Through prosecuting cases on the federal and state levels, Kaplan Fox has successfully shaped the law through winning many important decisions on behalf of our clients. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com.

If you have any questions about this investigation, your rights, or your interests, please contact:

Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(212) 329-8571
E-mail: jcampisi@kaplanfox.com

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
Fax:  (415) 772-4707
E-mail: lking@kaplanfox.com