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ATNM.US
id: 1547
Actinium Pharmaceuticals ($ATNM) Misleading Trial Results and FDA Approval Case
S.D. New York
Court1:25-cv-02553
Case number10/31/2022
Class period Start08/02/2024
Class period End05/26/2025
Lead Plaintiff motion deadline- $ATNM investors filed a claim against Actinium Pharmaceuticals for misleading statements about the likelihood of FDA approval for its lead drug, Iomab-B.
- After revealing on August 5, 2024, that the FDA would not accept its BLA without another trial, $ATNM fell nearly 60% in a single day.
Case Details:
Between October 31, 2022, and August 2, 2024, Actinium Pharmaceuticals promoted its Phase 3 Sierra Trial of Iomab-B, a targeted radiotherapy for patients with relapsed or refractory acute myeloid leukemia (AML), as a success. The company repeatedly emphasized that the trial met its primary endpoint—durable Complete Remission (DCR)—and claimed this would support FDA approval.
Executives frequently told investors that the trial was designed in collaboration with the FDA and implied that the regulator would not require additional survival data. However, they failed to disclose that the Sierra Trial did not meet its key secondary endpoint: Overall Survival (OS), which the FDA considers the critical benchmark for AML treatment approval. The trial’s design, including a 60% crossover rate from the control group, further compromised survival comparisons and undermined the clinical significance of the results.
On August 5, 2024, Actinium revealed the FDA had determined that the Sierra Trial data was not sufficient to support a Biologics License Application (BLA). The agency requested a new randomized study without crossover, forcing the company to delay its approval timeline indefinitely. Following the announcement, $ATNM dropped nearly 60%.
Based on these events, $ATNM investors filed a claim against Actinium Pharmaceuticals, accusing the company of the following:
- It misled investors about the strength of the Sierra Trial and the likelihood of FDA approval.
- It downplayed the importance of Overall Survival data and overstated FDA involvement in the trial design.
Considering all the representations, investors believe Actinium concealed critical trial flaws and regulatory risks to maintain its stock price and delay negative disclosures.
Case Status
Lead Plaintiff Appointment
Alleged Offence
Misleading Statements,
Financial Misrepresentation
Suspected Party
Directors,
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
08/05/2024
Lead Plaintiff Deadline
05/26/2025