Regulatory Momentum and Expanding Clinical Footprint Position Insight Molecular Diagnostics for a Pivotal 2026 Ramp

In a report released today, Michael Matson from Needham maintained a Buy rating on Insight Molecular Diagnostics, with a price target of $9.00.

Michael Matson has given his Buy rating due to a combination of factors tied to Insight Molecular Diagnostics’ execution and pipeline visibility. He notes that the company is nearly finished with its FDA in vitro diagnostic submission for GraftAssureDx, with only a slight slippage versus the prior year-end 2025 timeline, which he views as operationally manageable. At the same time, IMDX appears to be moving faster than expected on European and UK regulatory pathways, with key audits already completed and approvals now targeted for the first half of 2026, supporting a clearer commercialization roadmap.

Matson also points to growing clinical and commercial traction across the GraftAssure franchise as a key driver of his positive stance. GraftAssureIQ has reached its goal of being deployed across 20 research sites in North America and Europe, and management is planning a stepwise expansion toward 50 U.S. sites, aided by the GALACTIC registry study. In addition, IMDX has already lined up 17 transplant centers for its GraftAssureCore registry, with first patient samples expected in 2026. In his view, this combination of regulatory momentum, expanding clinical footprint, and the prospect of 2026 as a pivotal ramp year underpins the Buy rating on IMDX shares.

Matson covers the Healthcare sector, focusing on stocks such as Masimo, Penumbra, and TransMedics Group. According to TipRanks, Matson has an average return of 0.1% and a 42.77% success rate on recommended stocks.

In another report released today, Lake Street also maintained a Buy rating on the stock with a $8.00 price target.