Replies to post #21 on Edgewise Therapeutics Inc (EWTX)

[Whalatane]

I used to own CYTK and think I sold it because of this ...from the CYTK trial

Core echocardiographic left ventricular ejection fraction (LVEF) was observed to be <50% in 5 patients (3.5%) on aficamten compared to 1 patient (0.7%) on placebo.

Which means ( I think ) , their drug if approved would have the same REMS requirement as Mevacamten ( MYOK /BMS )
EWTX EDG-7500 HCM drug is expected to have better ejection fraction data which may mean if the drug is finally approved it wouldn't have a REMS requirement .
HCM is only one of their programs
The Canyon trial data in BECKERS is due Q4 ......so early days really with a lot of hurdles ahead

I haven't checked their financials but assume they will raise $ on any successful trial data

As always ... info only , not investment advice . Risk only what U can afford to lose etc etc
Kiwi

[Whalatane]

RMB Gr8 data ...especially

. Importantly, gradient reduction was achieved without a meaningful change in LVEF

So maybe no REMS limitation
Kiwi

[Whalatane]

CANYON Phase 2 placebo-controlled trial in adults with Becker : CANYON, the largest interventional Becker trial to date, includes 40 adults and 29 adolescents with a sevasemten treatment period of 12 months. The primary endpoint of CANYON is change in creatine kinase (CK) over the treatment period with additional measures collected, including North Star Ambulatory Assessment (NSAA), 100-meter timed test, biomarkers of muscle damage and MRI. The Company expects to report CANYON data in the fourth quarter of 2024.

Kiwi

[Whalatane]

Piper Sandler Maintains Overweight on Edgewise Therapeutics, Raises Price Target to $51