NEW YORK, NY / ACCESSWIRE / November 29, 2022 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims against Spectrum Pharmaceuticals, Inc. ("Spectrum" or the "Company") (NASDAQ:SPPI). Investors who purchased Spectrum securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/sppi.
The investigation concerns whether Spectrum violated federal securities laws.
On September 22, 2022, Reuters reported that advisers to the U.S Food and Drug Administration "voted against recommending Spectrum Pharmaceuticals' 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 AstraZeneca's Enhertu." On this news, Spectrum's stock price fell $0.207 per share, or 32.65%, to close at $0.427 per share on September 23, 2022. Then, on November 25, 2022, Spectrum disclosed that "that the Company 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."
If you are aware of any facts relating to this investigation or purchased Spectrum securities, you can assist this investigation by visiting the firm's site: www.bgandg.com/sppi. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC represents investors in securities fraud class actions and shareholder derivative suits. The firm has recovered hundreds of millions of dollars for investors nationwide. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact:
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Nathanson
212-697-6484 | [email protected]
SOURCE: Bronstein, Gewirtz and Grossman, LLC