Alpha Tau Submits to Japanese PMDA for Pre-Market Approval of Alpha DaRT in Patients with Recurrent Head and Neck Cancer
Trade with 70% Backtested Accuracy
Analyst Views on DRTSW
No data
About the author
Alpha Tau Achieves First Patient Treatment in U.S. Multi-Center Clinical Trial for Pancreatic Cancer
Pilot Study Initiation: Alpha Tau Medical has commenced a multi-center pilot study, IMPACT, to evaluate the safety and efficacy of Alpha DaRT combined with chemotherapy for patients with newly diagnosed unresectable pancreatic adenocarcinoma, a condition affecting up to 87% of patients at diagnosis.
Innovative Treatment Approach: The study aims to provide a localized treatment option using Alpha DaRT's targeted alpha radiation, potentially improving outcomes for patients with limited treatment options, while continuing their standard chemotherapy regimen.
Alpha Tau to Attend Five Investor Conferences in September
Company Announcement: Alpha Tau Medical Ltd. announced that CFO Raphi Levy will present at five investor conferences in September 2025, focusing on their innovative cancer therapy, Alpha DaRT.
Alpha DaRT Technology: The Alpha DaRT platform utilizes localized alpha particle radiotherapy to target solid tumors while minimizing damage to surrounding healthy tissue, with promising immuno-stimulatory effects.
Upcoming Conferences: Key events include the Citi 2025 Biopharma Summit, H.C. Wainwright Global Investment Conference, and others, where Mr. Levy will be available for one-on-one meetings with investors.
Forward-Looking Statements: The press release contains forward-looking statements regarding clinical trials and regulatory approvals, highlighting uncertainties and potential risks associated with the company's future performance.
Alpha Tau Announces First Quarter 2025 Financial Results and Provides Corporate Update
Clinical Trial Results: Interim results from three trials of Alpha DaRT in treating pancreatic cancer show over 90% disease control rate and significant survival benefits, while a combination trial with Keytruda in head and neck cancer demonstrates a 75% objective response rate.
Regulatory Approvals and Financial Update: Alpha Tau Medical received FDA approval for multiple investigational device exemptions to conduct clinical studies, achieved MDSAP certification for its manufacturing facility, and completed a $36.9 million financing to support ongoing operations and expansion efforts.
Alpha Tau to Participate in May Investor Conferences
Upcoming Investor Conferences: Alpha Tau Medical Ltd. will have CFO Raphi Levy presenting at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, and participating in 1x1 meetings at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025.
About Alpha Tau Medical: Founded in 2016, Alpha Tau focuses on developing the Alpha DaRT therapy for treating solid tumors, utilizing a method that delivers alpha radiation directly to tumors while minimizing damage to surrounding healthy tissue.
Alpha Tau Announces Closing of $36.9 Million Registered Direct Offering and Strategic Marketing Alliance with Oramed Pharmaceuticals
Alpha Tau Medical's Offering: Alpha Tau Medical Ltd. has successfully closed a registered direct offering, raising approximately $36.9 million by selling over 14 million ordinary shares to an affiliate of Oramed Pharmaceuticals at $2.612 per share, with plans to use the proceeds for corporate purposes and product development.
Strategic Partnership: The partnership with Oramed includes strategic services in investor and public relations, enhancing Alpha Tau's capabilities as it expands its clinical trials and manufacturing operations related to its innovative cancer therapy, Alpha DaRT.
Alpha Tau Receives Medical Device Single Audit Program (MDSAP) Certification
MDSAP Certification Achievement: Alpha Tau Medical Ltd. has received MDSAP certification for its manufacturing facility in Jerusalem, enhancing its commitment to quality and regulatory compliance while facilitating the global expansion of its alpha-radiation cancer therapy, Alpha DaRT.
Alpha DaRT Technology Overview: The Alpha DaRT therapy is designed for targeted treatment of solid tumors through intratumoral delivery of radium-224, aiming to effectively destroy tumor cells while minimizing damage to surrounding healthy tissue.
Alpha Tau Achieves First Patient Treatment in U.S. Multi-Center Clinical Trial for Pancreatic Cancer
Pilot Study Initiation: Alpha Tau Medical has commenced a multi-center pilot study, IMPACT, to evaluate the safety and efficacy of Alpha DaRT combined with chemotherapy for patients with newly diagnosed unresectable pancreatic adenocarcinoma, a condition affecting up to 87% of patients at diagnosis.
Innovative Treatment Approach: The study aims to provide a localized treatment option using Alpha DaRT's targeted alpha radiation, potentially improving outcomes for patients with limited treatment options, while continuing their standard chemotherapy regimen.
Alpha Tau to Attend Five Investor Conferences in September
Company Announcement: Alpha Tau Medical Ltd. announced that CFO Raphi Levy will present at five investor conferences in September 2025, focusing on their innovative cancer therapy, Alpha DaRT.
Alpha DaRT Technology: The Alpha DaRT platform utilizes localized alpha particle radiotherapy to target solid tumors while minimizing damage to surrounding healthy tissue, with promising immuno-stimulatory effects.
Upcoming Conferences: Key events include the Citi 2025 Biopharma Summit, H.C. Wainwright Global Investment Conference, and others, where Mr. Levy will be available for one-on-one meetings with investors.
Forward-Looking Statements: The press release contains forward-looking statements regarding clinical trials and regulatory approvals, highlighting uncertainties and potential risks associated with the company's future performance.
Alpha Tau Announces First Quarter 2025 Financial Results and Provides Corporate Update
Clinical Trial Results: Interim results from three trials of Alpha DaRT in treating pancreatic cancer show over 90% disease control rate and significant survival benefits, while a combination trial with Keytruda in head and neck cancer demonstrates a 75% objective response rate.
Regulatory Approvals and Financial Update: Alpha Tau Medical received FDA approval for multiple investigational device exemptions to conduct clinical studies, achieved MDSAP certification for its manufacturing facility, and completed a $36.9 million financing to support ongoing operations and expansion efforts.
Alpha Tau to Participate in May Investor Conferences
Upcoming Investor Conferences: Alpha Tau Medical Ltd. will have CFO Raphi Levy presenting at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, and participating in 1x1 meetings at the Lytham Partners Spring 2025 Investor Conference on May 29, 2025.
About Alpha Tau Medical: Founded in 2016, Alpha Tau focuses on developing the Alpha DaRT therapy for treating solid tumors, utilizing a method that delivers alpha radiation directly to tumors while minimizing damage to surrounding healthy tissue.
Alpha Tau Announces Closing of $36.9 Million Registered Direct Offering and Strategic Marketing Alliance with Oramed Pharmaceuticals
Alpha Tau Medical's Offering: Alpha Tau Medical Ltd. has successfully closed a registered direct offering, raising approximately $36.9 million by selling over 14 million ordinary shares to an affiliate of Oramed Pharmaceuticals at $2.612 per share, with plans to use the proceeds for corporate purposes and product development.
Strategic Partnership: The partnership with Oramed includes strategic services in investor and public relations, enhancing Alpha Tau's capabilities as it expands its clinical trials and manufacturing operations related to its innovative cancer therapy, Alpha DaRT.
Alpha Tau Receives Medical Device Single Audit Program (MDSAP) Certification
MDSAP Certification Achievement: Alpha Tau Medical Ltd. has received MDSAP certification for its manufacturing facility in Jerusalem, enhancing its commitment to quality and regulatory compliance while facilitating the global expansion of its alpha-radiation cancer therapy, Alpha DaRT.
Alpha DaRT Technology Overview: The Alpha DaRT therapy is designed for targeted treatment of solid tumors through intratumoral delivery of radium-224, aiming to effectively destroy tumor cells while minimizing damage to surrounding healthy tissue.
