Alpha Tau Medical Submits Pre-Market Approval Application for Alpha DaRT to FDA
Alpha Tau Medical announced the submission of the first module of its pre-market approval application to the U.S. Food and Drug Administration, following the FDA's previous decision to allow the company to use the more flexible modular approach. The company submitted the module as part of an application for the use of Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma for patients not indicated for surgery or standard radiation therapy, and for whom no curative systemic treatment is available. This module is focused on comprehensive documentation with respect to non-clinical studies as required under the PMA application, Alpha Tau said. Alpha Tau is currently conducting its multi-center pivotal ReSTART study exploring the use of Alpha DaRT in recurrent cSCC, one of five clinical trials currently approved in the U.S., and anticipates completing patient recruitment in Q1 2026. Alpha Tau has received Breakthrough Device Designation from the FDA in this indication as well as for recurrent glioblastoma multiforme and recurrent squamous cell carcinoma of the oral cavity with similar criteria, and is also part of the FDA Total Product Life Cycle Advisory Program to accelerate market access for the potential treatment of recurrent GBM.
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AIM ImmunoTech Plans $12 Million Rights Offering
- Rights Offering Overview: AIM ImmunoTech announced a proposed rights offering expected to generate $12 million in gross proceeds, which will be allocated for clinical trial expenses and debt repayment, indicating the company's commitment to future R&D.
- Subscription Rights Details: Each shareholder will receive a non-transferable subscription right to purchase units at $1,000 each, consisting of one share of convertible preferred stock and warrants for 1,492 shares of common stock, enhancing shareholder engagement.
- Timeline: Key dates for the rights offering include the record date on February 4, 2026, and the distribution date on February 5, with the subscription period running until February 23, ensuring timely participation for shareholders.
- Management Participation: Company leadership, including CEO Thomas K. Equels, has indicated a non-binding intention to participate in the rights offering, reflecting confidence in the company's future prospects.
AIM ImmunoTech Declares 1-for-1000 Stock Dividend for Shareholders
- Stock Dividend Announcement: AIM ImmunoTech has declared a stock dividend of one share for every 1,000 shares outstanding, scheduled for distribution on January 13, 2026, aimed at enhancing shareholder returns and boosting market confidence.
- Record Date Set: The dividend will be recorded for shareholders as of the close of business on January 9, 2026, ensuring that all eligible shareholders and holders of Alternate Securities receive the dividend, thereby strengthening the company's relationship with investors.
- Cash Compensation Mechanism: Fractional shares resulting from the dividend will be compensated in cash at a rate of $1.305 per share, ensuring shareholders do not lose out due to fractional shares, which enhances investor trust.
- Transfer Agent Management: The stock dividend will be administered by the company's transfer agent EQ, simplifying the process for shareholders, who will not need to take any action to receive their dividends, thus improving the shareholder experience.
