Prolonged Safety Uncertainty and Eroding Differentiation Keep EDG-7500 at Hold

Analyst James Condulis of Stifel Nicolaus maintained a Hold rating on Edgewise Therapeutics, boosting the price target to $16.00.

James Condulis has given his Hold rating due to a combination of factors related to both safety uncertainty and a more challenging competitive backdrop for EDG-7500. While recent data from Parts B and C at the 25 mg dose show encouraging signs of clinical activity without meaningful declines in ejection fraction or observed atrial fibrillation, the additional new-onset afib case in Part D reinforces lingering concerns stemming from the earlier afib signal. In Condulis’s view, the current afib incidence in the trial, even under cautious dosing and tight patient selection, appears elevated relative to published background rates in hypertrophic cardiomyopathy and compares unfavorably to competitor data such as aficamten, which has not shown new-onset afib in a similar setting.

Condulis also emphasizes that the key questions around afib risk and overall safety profile are unlikely to be definitively resolved before longer-term, controlled phase 3 data, which are still several years away, leaving investors exposed to prolonged uncertainty. At the same time, EDG-7500 has moved to an individualized titration regimen, weakening one of its original points of differentiation as the cardiac myosin inhibitor class becomes more established and regulators grow increasingly comfortable with existing options. With the next major catalyst not until Becker muscular dystrophy data in late 2026, and with tempered expectations for that readout, Condulis believes the risk/reward is balanced rather than compelling at current levels. As a result, he sees sufficient potential to remain engaged with the story, but not enough clarity or differentiation to justify a more constructive rating at this time.

Based on the recent corporate insider activity of 39 insiders, corporate insider sentiment is neutral on the stock.