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