Alpha Tau Medical Submits FDA Application for Alpha DaRT Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
0mins
Should l Buy DRTS?
Source: NASDAQ.COM
- Regulatory Milestone: Alpha Tau Medical has submitted the first module of its Pre-Market Approval application for Alpha DaRT therapy targeting recurrent cutaneous squamous cell carcinoma, marking a significant step toward potential U.S. market entry and offering new treatment options for patients.
- Innovative Treatment Approach: Alpha DaRT utilizes Diffusing Alpha-emitters Radiation Therapy to precisely destroy tumors while sparing surrounding healthy tissue, which could significantly enhance treatment outcomes for patients with difficult-to-treat skin cancers.
- Clinical Trial Progress: This submission coincides with Alpha Tau's ongoing ReSTART pivotal trial, with recruitment expected to complete by Q1 2026, and successful trial results will pave the way for commercialization.
- Accelerated Review Mechanism: The FDA's modular PMA pathway allows for staggered submission and feedback on each module, potentially expediting the overall review process and enhancing Alpha Tau's competitiveness in the complex medical technology landscape.
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Analyst Views on DRTS
Wall Street analysts forecast DRTS stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.710
Low
5.00
Averages
7.00
High
9.00
Current: 6.710
Low
5.00
Averages
7.00
High
9.00
About DRTS
Alpha Tau Medical Ltd is an Israel-based medical technology company that focuses on research, development and commercialization of Alpha DaRT Diffusing Alpha-emitters Radiation Therapy (Alpha DaRT) for the treatment of solid cancer. Company's technology relies on the diffusion of atoms that emit alpha particles within the tumor tissue, and enables alpha radiation to reach the the entire tumor. Precise amounts of radioactive radium-224 affixed that emit short-range alpha radiation enables to damages and kills cancer cells within a short period of time. The Company has one subsidiary Healthcare Capital Corp.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Alpha Tau Medical Reports FY GAAP EPS of -$0.42
- Earnings Report: Alpha Tau Medical reported a FY GAAP EPS of -$0.42, indicating challenges in profitability that may negatively impact investor confidence and stock performance.
- Cash Position: As of December 31, 2025, the company had cash and cash equivalents, short-term deposits, and restricted deposits totaling $76.9 million, an increase from $62.9 million at December 31, 2024, suggesting improved liquidity management.
- Future Outlook: Updates on pancreatic cancer and GBM indicate that Alpha Tau Medical is positioning itself for a strong and catalyst-rich 2026, potentially attracting more investor interest.
- Market Reaction: Despite the reported losses, the company's efforts in R&D and market expansion may yield positive market reactions in the future, particularly with new therapies and clinical trial advancements.
See More
Japan Approves New Head and Neck Cancer Treatment Device
- Innovative Treatment Device: HekaBio K.K. announces that its developed Alpha DaRT (Diffusing Alpha Radiation Therapy) device has received official approval in Japan, becoming the first country outside Israel to approve it, marking Japan's leadership in tumor treatment.
- Significant Market Potential: Designed for patients with unresectable locally advanced or recurrent head and neck cancer, this device offers a new therapeutic option, expected to significantly improve treatment outcomes and fill the gap left by conventional therapies.
- Clinical Trial Results: Clinical trials demonstrate that Alpha DaRT effectively disrupts tumor cell DNA, leading to cell death, with high safety and efficacy, providing crucial evidence for future clinical applications and potentially transforming head and neck cancer treatment.
- Strategic Collaboration and Development: HekaBio is closely collaborating with Japanese medical professionals to conduct post-marketing studies and explore reimbursement options for Alpha DaRT, indicating its long-term growth potential in the Japanese market and commitment to patients.
See More
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- Significant Stock Surge: Following the earnings report, TG Therapeutics shares jumped 11.6% to $31.10 on Wednesday, reflecting investor optimism about the company's growth potential, which may attract more capital inflow.
- Positive Market Reaction: Despite a broader market decline with the Nasdaq Composite falling over 200 points, TG Therapeutics' strong financial data allowed it to stand out among numerous stocks, showcasing its competitiveness in the biopharmaceutical sector.
- Optimistic Future Outlook: Although the financial figures are unaudited, the preliminary results suggest that the company is poised for continued growth, particularly in the marketing of its BRIUMVI product, which could further enhance its market share.
See More
Alpha Tau Medical Submits FDA Application for Alpha DaRT Therapy
- Regulatory Milestone: Alpha Tau Medical has submitted the first module of its Pre-Market Approval application for Alpha DaRT therapy targeting recurrent cutaneous squamous cell carcinoma, marking a significant step toward potential U.S. market entry and offering new treatment options for patients.
- Innovative Treatment Approach: Alpha DaRT utilizes Diffusing Alpha-emitters Radiation Therapy to precisely destroy tumors while sparing surrounding healthy tissue, which could significantly enhance treatment outcomes for patients with difficult-to-treat skin cancers.
- Clinical Trial Progress: This submission coincides with Alpha Tau's ongoing ReSTART pivotal trial, with recruitment expected to complete by Q1 2026, and successful trial results will pave the way for commercialization.
- Accelerated Review Mechanism: The FDA's modular PMA pathway allows for staggered submission and feedback on each module, potentially expediting the overall review process and enhancing Alpha Tau's competitiveness in the complex medical technology landscape.
See More
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- Alpha Tau FDA Submission: Alpha Tau Medical Ltd. submitted the first module of its pre-market approval application for Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma, resulting in a 5.36% stock rise, as this modular approach may expedite the approval process and enhance market confidence.
See More
Alpha Tau Medical Reports FY GAAP EPS of -$0.42
- Earnings Report: Alpha Tau Medical reported a FY GAAP EPS of -$0.42, indicating challenges in profitability that may negatively impact investor confidence and stock performance.
- Cash Position: As of December 31, 2025, the company had cash and cash equivalents, short-term deposits, and restricted deposits totaling $76.9 million, an increase from $62.9 million at December 31, 2024, suggesting improved liquidity management.
- Future Outlook: Updates on pancreatic cancer and GBM indicate that Alpha Tau Medical is positioning itself for a strong and catalyst-rich 2026, potentially attracting more investor interest.
- Market Reaction: Despite the reported losses, the company's efforts in R&D and market expansion may yield positive market reactions in the future, particularly with new therapies and clinical trial advancements.
See More
Japan Approves New Head and Neck Cancer Treatment Device
- Innovative Treatment Device: HekaBio K.K. announces that its developed Alpha DaRT (Diffusing Alpha Radiation Therapy) device has received official approval in Japan, becoming the first country outside Israel to approve it, marking Japan's leadership in tumor treatment.
- Significant Market Potential: Designed for patients with unresectable locally advanced or recurrent head and neck cancer, this device offers a new therapeutic option, expected to significantly improve treatment outcomes and fill the gap left by conventional therapies.
- Clinical Trial Results: Clinical trials demonstrate that Alpha DaRT effectively disrupts tumor cell DNA, leading to cell death, with high safety and efficacy, providing crucial evidence for future clinical applications and potentially transforming head and neck cancer treatment.
- Strategic Collaboration and Development: HekaBio is closely collaborating with Japanese medical professionals to conduct post-marketing studies and explore reimbursement options for Alpha DaRT, indicating its long-term growth potential in the Japanese market and commitment to patients.
See More
Biotech Stocks Surge: Coherus Up 9.09% in After-Hours Trading
- Coherus Performance: Coherus Oncology, Inc. (CHRS) rose 9.09% in after-hours trading, closing at $1.73 with a $0.14 gain, indicating strong investor confidence in its future prospects.
- Sensei Biotech Surge: Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% after hours, finishing at $12.47 with a $1.14 increase, reflecting positive market expectations for its products.
- uniQure Significant Jump: uniQure N.V. (QURE) posted a 9.96% rise in after-hours trading, closing at $24.95 with a $2.26 gain, suggesting investor optimism regarding its R&D progress.
- IO Biotech Strategic Exploration: Although IO Biotech, Inc. (IOBT) had no fresh news on Thursday, its stock still gained 4.19%, closing at $0.50, indicating market interest in its exploration of strategic alternatives, including potential mergers or asset sales.
See More
TG Therapeutics Reports $616 Million Revenue for FY 2025, Shares Surge 11.6%
- Strong Financial Performance: TG Therapeutics reported preliminary total global revenue of approximately $616 million for FY 2025, with Q4 U.S. net product revenue for BRIUMVI at about $182 million, indicating robust market performance that is expected to boost shareholder confidence.
- Significant Stock Surge: Following the earnings report, TG Therapeutics shares jumped 11.6% to $31.10 on Wednesday, reflecting investor optimism about the company's growth potential, which may attract more capital inflow.
- Positive Market Reaction: Despite a broader market decline with the Nasdaq Composite falling over 200 points, TG Therapeutics' strong financial data allowed it to stand out among numerous stocks, showcasing its competitiveness in the biopharmaceutical sector.
- Optimistic Future Outlook: Although the financial figures are unaudited, the preliminary results suggest that the company is poised for continued growth, particularly in the marketing of its BRIUMVI product, which could further enhance its market share.
See More
Alpha Tau Medical Submits FDA Application for Alpha DaRT Therapy
- Regulatory Milestone: Alpha Tau Medical has submitted the first module of its Pre-Market Approval application for Alpha DaRT therapy targeting recurrent cutaneous squamous cell carcinoma, marking a significant step toward potential U.S. market entry and offering new treatment options for patients.
- Innovative Treatment Approach: Alpha DaRT utilizes Diffusing Alpha-emitters Radiation Therapy to precisely destroy tumors while sparing surrounding healthy tissue, which could significantly enhance treatment outcomes for patients with difficult-to-treat skin cancers.
- Clinical Trial Progress: This submission coincides with Alpha Tau's ongoing ReSTART pivotal trial, with recruitment expected to complete by Q1 2026, and successful trial results will pave the way for commercialization.
- Accelerated Review Mechanism: The FDA's modular PMA pathway allows for staggered submission and feedback on each module, potentially expediting the overall review process and enhancing Alpha Tau's competitiveness in the complex medical technology landscape.
See More
Alumis Inc. (ALMS) Shares Surge 17.33% on Phase 3 Clinical Trial Data Announcement
- Alumis Clinical Progress: Alumis Inc. announced it will report topline data from its Phase 3 ONWARD clinical trial for moderate-to-severe plaque psoriasis on January 6, 2026, leading to a 17.33% stock surge, reflecting strong investor optimism ahead of the results.
- Genelux Trial Results: Genelux Corp. saw a 10.92% increase in share price following interim results from two ongoing trials, indicating that its Olvi-Vec may effectively resensitize tumors in small cell and non-small cell lung cancer patients, boosting market confidence in its product.
- Bright Minds Conference Announcement: Bright Minds Biosciences Inc. will host a conference call on January 6, 2026, to report results from its Phase 2 trial for drug-resistant absence seizures, with an 8.42% stock increase reflecting market anticipation for its findings.
- Alpha Tau FDA Submission: Alpha Tau Medical Ltd. submitted the first module of its pre-market approval application for Alpha DaRT to treat recurrent cutaneous squamous cell carcinoma, resulting in a 5.36% stock rise, as this modular approach may expedite the approval process and enhance market confidence.
See More
