Actinium Pharmaceuticals, Inc.
| Company Name | Actinium Pharmaceuticals, Inc. |
| Stock Symbol | ATNM |
| Class Period | October 31, 2022 to August 02, 2024 |
| Lead Plaintiff Motion Deadline | May 27, 2025 |
On August 5, 2024, before market hours, Actinium issued a press release providing an update on the planned Biologics License Application (“BLA”) filing for its radiotherapy product, Iomab-B, revealing that the FDA had determined that “the analyses from the [Phase 3 “Sierra Trial”] do not adequately support a BLA filing for Iomab-B and requires an additional clinical study.”
On this news, Actinium’s stock price fell $3.69, or 59.8%, to close at $2.48 per share on August 5, 2024, thereby injuring investors.
The complaint alleges that, during the Class Period, Defendants failed to disclose that: (1) the Company’s data from the Sierra Trial was unlikely to satisfy the FDA’s guidelines for the acceptance and approval of the Company’s Iomab-B BLA; (2) the additional analyses, including long-term follow-ups that purportedly demonstrated a trend towards improved Overall Survival that the Company provided to the FDA in an attempt to mitigate Sierra’s poor OS data were unlikely to satisfy the FDA’s guidelines for the acceptance and approval of the Company’s Iomab-B BLA; (3) as a result, the FDA would likely refuse to review the Iomab-B BLA or, if it did consider that BLA, that the application in its current form was unlikely to be approved; and (4), as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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