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Shares of Edgewise Therapeutics (EWTX) traded 20% higher on Wednesday morning after the company announced positive safety data from the ongoing multi-part mid-stage clinical trial of EDG-7500 in hypertrophic cardiomyopathy (HCM).
Earlier this year, the company reported positive results from Part B and Part C 50 mg and 100 mg fixed dose cohorts of the trial in which EDG-7500 administration led to improvements in key HCM disease markers. Hypertrophic Cardiomyopathy (HCM) is a genetic heart condition where the heart muscle thickens, making it harder to pump blood out, stiffening the heart, and potentially causing irregular rhythms, often leading to fatigue, shortness of breath, chest pain, or fainting.
The company said on Wednesday that it also evaluated a lower 25mg fixed dose in certain participants in Parts B and C and evidence of clinical activity was observed across key HCM disease markers. A favorable safety profile was observed with no clinically meaningful changes in left ventricular ejection fraction (LVEF) and no events of atrial fibrillation (AF), it added.
The company also reported interim safety results from Part D of the study and said that EDG-7500 generally had a favorable safety profile and was well tolerated.
“The safety profile observed with EDG-7500 to date, across both healthy volunteers and the CIRRUS-HCM trial, supports the potential use of EDG-7500 in diverse HCM patient populations,” the company said.
The company, however, said that a single adverse event of new onset AF was reported in Part D of the trial but added that the investigator deemed it as not related to the study drug. The trial participant was not on active cardiac monitoring at the time and had a history of arrhythmias, including supraventricular tachycardia, the company said.
Edgewise is now on track to deliver comprehensive efficacy and safety data from Part D of the mid-stage trial in the second quarter of 2026. It is looking forward to starting a late-stage trial by 2026-end.
Stifel thinks the update still leaves questions on safety that'll take more than additional open-label data to disprove. The analyst is now looking forward to longer-term/controlled late-stage data.
As per Stifel, the next big catalyst for the stock is data from the late-stage trial being conducted by the company for its drug Sevasemten in patients with Becker muscular dystrophy, a rare, X-linked genetic disorder causing progressive muscle weakness, mainly in males. The results from the trial are expected in the fourth quarter of 2026.
Truist, meanwhile, kept a ‘Buy’ rating and $46 price target on Edgewise Therapeutics following the company's updates. Truist remains bullish on the opportunity for EDG-7500 in both obstructive HCM and non-obstructive HCM given signs of efficacy in both patient groups, the analyst told investors in a research note.
H.C. Wainwright, which has a $42 price target and ‘Buy’ rating on Edgewise, sees the data reinforcing the drug’s potential for differentiation.
On Stocktwits, retail sentiment around EWTX rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours while message volume increased from ‘high’ to ‘extremely high’ levels.
EWTX stock is down by 2% this year and by about 12% over the past 12 months.
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