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Shares of Alpha Tau Medical (DRTS) drew strong retail attention on Friday, rising nearly 4% in pre-market trading after the company announced key progress in its pancreatic cancer program, including regulatory approval to expand its ongoing trial by enrolling an additional 10 patients.
On Thursday, the U.S. Food and Drug Administration (FDA) cleared an Investigational Device Exemption (IDE) supplement to expand its pancreatic cancer study, known as the IMPACT trial, which is testing its Alpha DaRT therapy alongside chemotherapy.
The update allows the company to enroll 10 additional patients receiving the chemotherapy combination Gemcitabine and Abraxane, split evenly between locally advanced and metastatic pancreatic cancer cases. This expansion takes the total enrollment to 40 patients.
The IMPACT study is a multi-center trial across the U.S., Canada, and Israel, focusing on patients with recently diagnosed, inoperable pancreatic adenocarcinoma. The main goal of the study is to evaluate safety, feasibility, and tolerability, while also tracking tumor response, disease progression, survival outcomes, and patient-reported pain relief.
Retail sentiment for DRTS on Stocktwits turned ‘bullish’ from ‘neutral,’ a day earlier, amid ‘high’ message volumes. Chatter on the platform was up by 200% over the past 24 hours.
One user said the trial expansion wouldn’t have taken place if the “safety profile wasn’t looking solid.”
Another user was bullish on the company’s prospects for treating pancreatic cancer.
Alpha Tau Medical also said it treated the first patient in its ACAPELLA trial, marking the debut of its Alpha DaRT therapy for pancreatic cancer in Europe. The study is testing Alpha DaRT alongside Capecitabine in patients with inoperable, locally advanced disease who have already completed standard chemotherapy.
Management said the trial targets a major care gap, as there is currently no standard follow-up treatment for such patients. Pancreatic cancer remains highly lethal, with about 30% of Europe’s 140,000 annual cases diagnosed at this stage.
“Over forty thousand Europeans each year are diagnosed with inoperable locally advanced pancreatic cancer, and even if there are some patients who have managed to complete first-line chemotherapy, there remains no established next step, no standard treatment path, and an inevitable progression for the great majority. That is the great unmet need ACAPELLA was designed to address,” CEO Uzi Sofer said.
DRTS shares have surged more than 57% so far this year.
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