One of the biopharma company’s heart drugs performs as well as initially hoped.
Shares of biopharma outfit Edgewise Therapeutics (EWTX 46.07%) soared more than 50% today, reaching a three-year high following an update on the clinical testing of its cardiac drug EDG-7500. The treatment shows promise in two related but distinct trials as a treatment for certain patients with improper bloodflow within the heart.
Heart drug EDG-7500 works as hoped
On Thursday, Edgewise Therapeutics published data regarding the phase 1 testing of EDG-7500 as a therapy for obstructive hypertrophic cardiomyopathy, or HCM, a condition marked by thickening of the left heart ventricle wall that can cause it to work less effectively. In this particular test of healthy patients, the drug was well tolerated, but more importantly, didn’t lead to lowered left ventricular ejection fraction levels. That is to say, the treatment doesn’t appear to cause the inefficient bloodflow sometimes associated with some other cardiac drugs.
The phase 2 CIRRUS-HCM test of EDG-7500 looked at the efficacy and tolerability of the drug given in single doses specifically as a treatment for obstructive hypertrophic cardiomyopathy. This administration also worked as hoped without leading to a meaningful drop in the aforementioned left ventricular ejection fraction levels. The CIRRUS trial further suggests the drug — at higher doses anyway — could potentially help prevent other forms of heart failure in select patients.
Not enough reason to buy Edgewise Therapeutics stock yet
It’s a win to be sure. But, keep it in perspective.
Even if an approval and commercialization of EDG-7500 is now in the cards, that’s still years away. The biopharma company’s still unprofitable in the meantime, and is still selling stock to fund operations. Indeed, it’s not even generating revenue yet, with nothing in its developmental pipeline further along than phase 2 testing. The FDA requires three full phases of clinical testing before it can approve any new drug, and the approval process itself can take well over a year once the third and final phase of trials are finalized and the results are tabulated and submitted.
Nevertheless, Edgewise Therapeutics may be a pharmaceutical name worth adding to your long-term watch list. Its focus on the underserved markets of muscular dystrophy and hypertrophic cardiomyopathy could allow it to become a strong competitor (or perhaps even a market leader) on both fronts. It’s just going to take time to know for sure. But the market’s not always patient.
Meanwhile, today’s enormous surge simply looks more like an opportunity for would-be profit-takers than a clarion call for new buyers.
James Brumley has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
