SEC v. Stefano R. Carchedi; Marie L. Foegh Ramwell; and James G. Cullem, No. LR-26265, District of Massachusetts (Mar. 12, 2025) — Press Release
raw: Stefano R. Carchedi; Marie L. Foegh Ramwell; and James G. Cullem
Stefano R. Carchedi; Marie L. Foegh Ramwell; and James G. Cullem, No. 1:25-cv-10599 (Mar. 12, 2025)
summary
Former Allarity Therapeutics executives Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem were charged by the SEC for concealing negative FDA feedback to mislead investors about their cancer drug's approval prospects.
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The SEC charged former Allarity Therapeutics executives Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem with violating the Securities Act of 1933 and the Securities Exchange Act of 1934. The defendants allegedly concealed that the FDA recommended a new Phase III clinical trial for the cancer drug dovitinib due to insufficient data. While specific dollar amounts were not disclosed, the SEC is seeking permanent injunctions, disgorgement, civil monetary penalties, and officer and director bars.
narrative
The SEC has filed charges against former Allarity Therapeutics executives Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem for a scheme to mislead investors regarding the flagship cancer drug dovitinib. In February 2020, the FDA recommended against seeking approval for the drug, suggesting instead that a new Phase III clinical trial was necessary. Rather than disclosing this, the executives issued false press releases and SEC filings to maintain investor optimism and raise capital. Carchedi specifically allegedly signed documents that propagated these misleading claims. The defendants face charges for violating various sections of the Securities Act of 1933 and the Securities Exchange Act of 1934. The SEC is seeking permanent injunctions, disgorgement with interest, civil penalties, and officer and director bars for all three defendants.
Classified accounting-fraud(confidence 80%). EDGAR detection: forms 10-K/10-Q/8-K/NT 10-K· recall 80% / precision 48%. detection rule →
Statutes
Parties
Securities and Exchange CommissionStefano R. CarchediMarie Foegh RamwellStefano CarchediJames G. CullemMarie L. Foegh Ramwell
Keywords
securities exchangecarchedifoeghcullemstefano carchedicarchedi mariemarie foeghfoegh ramwellramwell jamesjames cullemsecsecuritiesallarityexchange commissionfoegh cullem
Exhibits & Attached Documents (1)
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- agency Securities and Exchange Commission
- person stefano r. carchedi
Triples 10
- Securities And Exchange Commission filed charges against Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem
- Securities And Exchange Commission charges Stefano R. Carchedi with violating Section 17(a) of the Securities Act of 1933, Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder
- Securities And Exchange Commission charges Marie L. Foegh Ramwell and James G. Cullem with violating Sections 17(a)(1) and (3) of the Securities Act, Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder
- Food And Drug Administration recommended against seeking approval for dovitinib
- Food And Drug Administration recommended Allarity conduct a new Phase III clinical trial
- Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem concealed from investors a harsh critique levied by the Food and Drug Administration in February 2020 about dovitinib's likelihood of FDA approval
- Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem misled investors by creating press releases that propagated false and misleading claims about dovitinib’s likelihood of FDA approval
- Stefano R. Carchedi signed several documents filed with the SEC or posted on Allarity’s website that misled investors about dovitinib’s prospects for FDA approval
- Securities And Exchange Commission seeks permanent injunctions, disgorgement with prejudgment interest, civil monetary penalties, and officer and director bars against all defendants
- Securities And Exchange Commission is being handled by Dawn Edick, David Fox, Susan Cooke and Amy Gwiazda of the Boston Regional Office
PDF (from attached: complaint)
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U.S. SECURITIES AND EXCHANGE COMMISSION Litigation Release No. 26265 / March 12, 2025 Securities and Exchange Commission v. Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem, No. 1:25-cv-10599 (D. Mass. filed Mar. 12, 2025) SEC Charges Three Former Biopharmaceutical Company Executives with Scheme to Mislead About Cancer Drug Application The Securities and Exchange Commission today filed charges against Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem—the former chief executive officer, chief medical officer, and chief business officer of Massachusetts-based biopharmaceutical company Allarity Therapeutics, Inc., respectively—for scheming to conceal from investors a harsh critique levied by the Food and Drug Administration in February 2020 about the likelihood that dovitinib, Allarity’s flagship cancer drug candidate, would be approved by the FDA. The SEC’s complaint alleges Carchedi, Foegh and Cullem learned in February 2020 that the FDA recommended against seeking approval for dovitinib because Allarity’s data was insufficient and instead recommended Allarity conduct a new Phase III clinical trial—something it had no intention of doing. According to the SEC’s complaint, rather than revealing the FDA’s negative feedback to investors, Carchedi, Foegh and Cullem misled investors by creating press releases that propagated false and misleading claims about dovitinib’s likelihood of FDA approval while Allarity raised money from investors to stay afloat. Carchedi also allegedly signed several documents filed with the SEC or posted on Allarity’s website that similarly misled investors about dovitinib’s prospects for FDA approval. The SEC’s complaint, filed in the District Court for the District of Massachusetts, charges Carchedi with violating Section 17(a) of the Securities Act of 1933, Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder and charges Foegh and Cullem with violating Sections 17(a)(1) and (3) of the Securities Act, Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder. The SEC seeks permanent injunctions, disgorgement with prejudgment interest, civil monetary penalties, and officer and director bars against all defendants. The SEC’s investigation is being handled by Dawn Edick, David Fox, Susan Cooke and Amy Gwiazda of the Boston Regional Office.
OCR text (2,369c · html-text · 99% conf)
U.S. SECURITIES AND EXCHANGE COMMISSION Litigation Release No. 26265 / March 12, 2025 Securities and Exchange Commission v. Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem, No. 1:25-cv-10599 (D. Mass. filed Mar. 12, 2025) SEC Charges Three Former Biopharmaceutical Company Executives with Scheme to Mislead About Cancer Drug Application The Securities and Exchange Commission today filed charges against Stefano R. Carchedi, Marie L. Foegh Ramwell, and James G. Cullem—the former chief executive officer, chief medical officer, and chief business officer of Massachusetts-based biopharmaceutical company Allarity Therapeutics, Inc., respectively—for scheming to conceal from investors a harsh critique levied by the Food and Drug Administration in February 2020 about the likelihood that dovitinib, Allarity’s flagship cancer drug candidate, would be approved by the FDA. The SEC’s complaint alleges Carchedi, Foegh and Cullem learned in February 2020 that the FDA recommended against seeking approval for dovitinib because Allarity’s data was insufficient and instead recommended Allarity conduct a new Phase III clinical trial—something it had no intention of doing. According to the SEC’s complaint, rather than revealing the FDA’s negative feedback to investors, Carchedi, Foegh and Cullem misled investors by creating press releases that propagated false and misleading claims about dovitinib’s likelihood of FDA approval while Allarity raised money from investors to stay afloat. Carchedi also allegedly signed several documents filed with the SEC or posted on Allarity’s website that similarly misled investors about dovitinib’s prospects for FDA approval. The SEC’s complaint, filed in the District Court for the District of Massachusetts, charges Carchedi with violating Section 17(a) of the Securities Act of 1933, Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder and charges Foegh and Cullem with violating Sections 17(a)(1) and (3) of the Securities Act, Section 10(b) of the Exchange Act and Rules 10b-5(a) and (c) thereunder. The SEC seeks permanent injunctions, disgorgement with prejudgment interest, civil monetary penalties, and officer and director bars against all defendants. The SEC’s investigation is being handled by Dawn Edick, David Fox, Susan Cooke and Amy Gwiazda of the Boston Regional Office.