Edgewise Therapeutics Inc (EWTX)

[Whalatane]

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

[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]

New high following presentation
Topline data from CANYON is anticipated in 4Q24

Phase 2 trial in adults with Becker

Kiwi

[Whalatane]

From IBD ..

..The biotech company tested its drug, EDG-7500, in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy. In this disease, a genetic mutation causes the heart ventricles to thicken. This limits cardiac function and exercise capacity.

After a single dose, patients showed improved blood flow from the left ventricle. But sometimes drugs can do their job too well, suppressing cardiac function — a measure known as reduced left ventricular ejection fraction, or LVEF. But patients didn't show meaningful reductions in LVEF.. my emphasis

Kiwi

[Whalatane]

RMB Gr8 data ...especially

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

So maybe no REMS limitation
Kiwi

[Whalatane]

Topline data from CANYON is anticipated in 4Q24

Phase 2 trial in adults with Becker

Kiwi

[Whalatane]

Sizable sell off despite this again today
RBC Capital Reiterates Outperform on Edgewise Therapeutics, Maintains $32 Price Target

Kiwi

[Whalatane]

RBC Capital Reiterates Outperform on Edgewise Therapeutics, Maintains $32 Price Target

Kiwi

[Whalatane]

JPMorgan Raises Price Target on Edgewise Therapeutics to $30 From $27, Maintains Overweight Rating
Kiwi

[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

[rosemountbomber]

Thanks for all the info Kiwi. Been a long busy day so I will have to do some more DD on this one but it appears to be promising. The fact that the drug does not have the ejection fraction problem is important in my books. This could be another CYTK. My one worry is that it has had quite a sunup in 2024 already and hopefully not everything is priced in yet.

[Whalatane]

Before EWTX there was MYOK in HCM ...bt out at $225 a share .
EWTX hired some MYOK folks after this buyout
https://news.bms.com/news/details/2020/Bristol-Myers-Squibb-to-Acquire-MyoKardia-for-13.1-Billion-in-Cash/default.aspx

Kiwi

[Whalatane]

Watch for a technical breakout as market anticipates the P1 HCM data
Mavacamten is I think the drug currently approved for HCM ( heart contractibility problems ) . The problem is it lowers ejection fraction ( the pump out movement ) to low for about 20% of the patients so it has a REMS rating limiting its use.
EWTX EDG-5506 works the same way but without the ejection fraction problem

Data due this Qt ( Q3 )

Kiwi

[Whalatane]

Piper Sandler analyst Yasmeen Rahimi maintains Edgewise Therapeutics ( EWTX ) with a Overweight and maintains $48 price target.

Kiwi

[Whalatane]

RMB. some HCM P1 data due late Aug / Sept ...
Kiwi

[Whalatane]

RMB. I think we are due for data from the LYNX trial

, Edgewise Therapeutics expects to report 3-month data from the Phase 2 LYNX trial for EDG-5506 in the second quarter of 2024. The LYNX trial is a Phase 2 dose-ranging study to evaluate the safety and efficacy of EDG-5506 in patients with Duchenne muscular dystrophy (DMD).

New high today

Kiwi

[Whalatane]

Wedbush Reiterates Outperform on Edgewise Therapeutics, Maintains $26 Price Target

I'm surprised stock didn't do better on recent P 2 data ...which was supposed to " de risk " their program

Kiwi

[Whalatane]

BOULDER, Colo., February 13, 2024--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne.
EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy (Becker).
The FDA previously granted EDG-5506 Orphan Drug Designation (ODD) for the treatment of Duchenne and Becker, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designation for the treatment of Becker.
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Kiwi

[Whalatane]

RMB. for what its worth ...both stocks I mentioned are now "technically " over bought ...so some pull back near term is likely
jmo
Kiwi

[Whalatane]

RMB. EWTX up 21 % in past week. ( since your post )
VERA ,,,which I think U saw me posting on at the AUPH board ...up 28%
Both I think at 52 wk highs

Usually I find it best to initiate small positions ...follow ..and then if the data still looks good , add on a pullback due to some unrelated event .
Both of these Co's have a lot of data coming out in 2024

Kiwi

[Monksdream]

EWTX new 52 week high

[Monksdream]

EWTX new 52 week high

[Whalatane]

Jonathan C. Fox, M.D., Ph.D., FACC
DIRECTOR
Jonathan C. Fox, M.D., Ph.D., FACC, serves as a member of our board of directors and is the president and chief medical officer for cardiovascular and renal diseases at BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical stage biotechnology company developing novel, genetically targeted therapies. Prior to that, Dr. Fox served as the chief medical officer of MyoKardia, Inc. Additionally, he worked as a consultant at Nigel-Montgomery, LLC, and held various senior R&D positions successively at SmithKline Beecham, Merck Research Laboratories and AstraZeneca. He was also on the faculty of the University of Pennsylvania School of Medicine. Dr. Fox serves on the board at ML BioSolutions and is a trustee of the Lankenau Institute for Medical Research. He is currently an adjunct Professor of Medicine at the Stanford University Cardiovascular Institute. He received his A.B. in biology, his Ph.D. in experimental pathology and his M.D. from the University of Chicago, and completed his training in Internal Medicine and Cardiology at Duke University. Dr. Fox is ABIM Certified in Cardiovascular Diseases and is a Fellow of the American College of Cardiology.

MyoKardia was bt out by BMS
Kiwi

[Whalatane]

RMB. You might look at TNYA also ...similar space. Ceo is one very smart guy and is backed by the Column group ( smart team )
Early days tho .
EWTX is far further along

BOTH are high speculative ...so.....etc
Kiwi

[rosemountbomber]

Kiwi you have peaked my interest in EWTX

The opportunity seems to be here, but I will try to exhibit something I rarely do, namely; patience.

It has risen a bunch in a short time and I hope to pick some up after a bit of a retracement.

[Whalatane]

EWTX. Best Co I've seen in this area since MYOK ...which was eventually bt out .
Kiwi

[Whalatane]

Impressive presentation at JPM 2024 . Fast tracked but the earliest they are likely to have an approved drug is early 2026...if all goes well
Kiwi

[goodfree]

Looks like we may have hit the bottom lol

[goodfree]

Jumped in at $30 today hope we have a good run here

[crudeoil24]

Edgewise Therapeutics, Inc. (NASDAQ: EWTX) gained 87.5% to close at $30.00 after pricing its IPO at $16 per share.

[crudeoil24]

Edgewise Therapeutics, Inc. is a clinical-stage biopharmaceutical company that is developing orally bioavailable, small molecule therapies for musculoskeletal diseases. The Company is principally focused on discovering, developing and commercializing treatments for rare muscle disorders. Its platform utilizes custom-built throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. The Company's lead candidate, EDG-5506, is an orally administered allosteric, selective, fast myofiber (type II) myosin small molecule inhibitor designed to address the root cause of dystrophinopathies, including Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD). The Company's research programs include EDG-6289, EDG-002 and EDG-003.