H.C. Wainwright has raised its price target on Alpha Tau Medical Ltd. (NASDAQ: DRTS) to $12.00 from $9.00 and has maintained a Buy rating on the shares. The stock is trading at $7.39, representing a 176% gain over the previous 12 months and sitting close to its 52-week high of $7.89.
Japan's Ministry of Health, Labour and Welfare granted marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. This authorization marks the first regulatory approval of Alpha DaRT outside of Israel and establishes a pathway for the technology in the Japanese market.
Under the terms of the approval, Alpha Tau Medical is required to conduct post-market surveillance in Japan involving 66 patients across five clinical centers. The company has stated that it will collaborate with Japanese clinicians to carry out the study and collect additional clinical evidence on Alpha DaRT's safety profile and clinical performance.
Alpha Tau Medical also indicated plans to initiate discussions with the MHLW about potential reimbursement approaches for Alpha DaRT in Japan. Separately, the company intends to engage with the Pharmaceuticals and Medical Devices Agency - PMDA - on the possibility of conducting additional clinical studies in Japan to evaluate Alpha DaRT in other tumor indications.
H.C. Wainwright's analysis raised the firm's estimated market value to $992 million, representing roughly $12 per share, while the company's current market capitalization stands at $631 million. InvestingPro analysis cited in the reporting notes that, at present market levels, the stock appears overvalued. Additional InvestingPro resources reportedly include 11 more tips and expanded financial health metrics for users who seek deeper insight.
Beyond the regulatory milestone in Japan, Alpha Tau Medical has provided several clinical and regulatory updates. The company presented final results from its first-in-human pancreatic cancer study at the 2026 ASCO Gastrointestinal Cancers Symposium. In that cohort of 32 patients with Stage II, III, or IV pancreatic ductal adenocarcinoma, the study reported a 22% objective response rate and an 81% disease control rate.
Alpha Tau Medical also submitted the first module of a pre-market approval application to the U.S. Food and Drug Administration for Alpha DaRT as a treatment for recurrent cutaneous squamous cell carcinoma. The FDA permitted the company to use a modular submission approach for this application.
In additional clinical activity, the company announced treating the first patient with recurrent glioblastoma multiforme in a U.S. pilot study of Alpha DaRT. That study employs a novel delivery approach intended for intracranial use. Following this announcement, H.C. Wainwright reiterated its Buy rating for Alpha Tau Medical and maintained a price target of $9.00, according to the report.
Investors and market participants face a range of signals: regulatory progress and encouraging early clinical data on one hand, and valuation cautions from market analysis on the other. The company has multiple regulatory and clinical pathways in motion across Japan and the U.S., but it will need to complete required post-market studies and pursue reimbursement discussions to translate approval into commercial uptake.