Alpha Tau Announces Acceptance Into FDA's Total Product Life Cycle Advisory Program to Accelerate Market Access to Alpha DaRT® for Patients with Recurrent Glioblastoma Multiforme
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 21 2024
0mins
Should l Buy DRTS?
Source: Newsfilter
FDA Acceptance into TAP Program: Alpha Tau Medical Ltd. has been accepted into the FDA's Total Product Life Cycle Advisory Program to expedite market access for its cancer therapy, Alpha DaRT, aimed at treating recurrent glioblastoma multiforme.
Alpha DaRT Technology Overview: Alpha DaRT utilizes alpha-emitters for targeted radiation therapy, designed to effectively destroy solid tumors while minimizing damage to surrounding healthy tissue.
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Analyst Views on DRTS
Wall Street analysts forecast DRTS stock price to fall
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.230
Low
5.00
Averages
7.00
High
9.00
Current: 7.230
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.
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- 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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See More
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- Investor Engagement: The event will include one-on-one meetings with institutional investors, aimed at strengthening relationships with potential investors and enhancing the company's visibility in the capital markets, thereby laying the groundwork for future financing.
- Technology Background: Alpha DaRT® is an innovative alpha-radiation cancer therapy focused on treating solid tumors through the intratumoral delivery of radium-224 sources, designed to improve treatment precision and efficacy while minimizing damage to surrounding healthy tissue.
- Company Vision: Founded in 2016, Alpha Tau Medical is dedicated to the research, development, and commercialization of Alpha DaRT®, aiming to carve out a niche in the oncology treatment landscape with its unique therapeutic approach to drive long-term growth.
See More
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Historic Milestone in Cancer Treatment: Alpha Tau Medical Ltd. has successfully treated the first patient in a U.S. pilot trial for recurrent glioblastoma using its Alpha DaRT technology, marking a significant advancement in treating this aggressive cancer.
Innovative Treatment Approach: Alpha DaRT delivers high-energy alpha particles directly into tumors, aiming to destroy cancer cells while minimizing damage to surrounding healthy tissue, and is supported by the FDA's Breakthrough Device Designation.
Pilot Study Details: The trial will enroll up to ten patients with recurrent glioblastoma who are not candidates for surgery, focusing on evaluating the feasibility and safety of the treatment based on promising preclinical results.
Market Response: Following the announcement, Alpha Tau's stock saw a notable increase, closing at $4.23 and rising to $4.70 in after-hours trading, reflecting investor optimism about the potential of the new therapy.
See More
