Alpha Tau Announces FDA Approval of IDE Supplement to Expand Pilot Trial of Alpha DaRT® to Thirty Patients with Pancreatic Cancer in Two Cohorts, with Locally Advanced or Metastatic Disease

On February 3, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients (Press release, Alpha Tau Medical, FEB 3, 2025, View Source [SID1234649991]).

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The IDE supplement allows the Company to include an additional cohort for locally advanced pancreatic cancer patients, and to increase the number of each cohort to 15 patients, for a total of 30 patients across the two cohorts, at up to 10 U.S. clinical trial sites.

Alpha Tau CEO Uzi Sofer commented, "Following the incredible data that we released last week, analyzing disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT, we welcome the news of this IDE supplement as we continue to move forward, full steam ahead, in our efforts to explore a new treatment for patients with this deadly disease as quickly as possible."

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On February 3, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, FEB 3, 2025, View Source [SID1234649990]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On January 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to eight individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 13,000 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.