Advancing Alpha DaRT: Regulatory Momentum, Pipeline Expansion, and Favorable Risk–Reward Support Buy Rating on Alpha Tau Medical

Analyst Yi Chen from H.C. Wainwright reiterated a Buy rating on Alpha Tau Medical Ltd and keeping the price target at $9.00.

Yi Chen has given his Buy rating due to a combination of factors related to Alpha Tau Medical’s progressing clinical and regulatory milestones for Alpha DaRT. The company has submitted the first module of its pre-market approval application to the FDA for treating recurrent cutaneous squamous cell carcinoma, with the regulator allowing a modular filing that enables ongoing feedback and potentially faster review. In addition, the pivotal ReSTART trial in this indication is on track to finish patient enrollment in the first quarter of 2026, and Alpha DaRT holds Breakthrough Device status, underscoring both the therapy’s promise and the seriousness of the unmet need.

Yi Chen also highlights the strategic expansion of Alpha DaRT into difficult-to-treat cancers such as pancreatic adenocarcinoma through the IMPACT pilot study, which is evaluating safety, feasibility, and early efficacy signals when combined with standard chemotherapy. This trial targets patients with unresectable locally advanced or metastatic disease, a population with poor survival outcomes and limited treatment options, reinforcing the platform’s potential value. Early indications that Alpha DaRT may stimulate a broader systemic anti-tumor response further support its differentiation. Taken together, the advancing regulatory path in cSCC, pipeline diversification into high-need oncology indications, and the potential for meaningful clinical benefit underpin Yi Chen’s conviction in a favorable risk–reward profile and the reiteration of a Buy rating.