Capricor Therapeutics Inc (NASDAQ:CAPR) shares are surging 6% today on the heels of H.C. Wainwright analyst Joseph Pantginis‘s new burst of confidence on the drug maker’s prospects. Particularly, the analyst glances ahead to fourth quarter Duchenne muscular dystrophy (DMD) drivers “now that cardio dust has settled” from negative publicity circling the firm’s CAP-1002 ALLSTAR trial evaluating heart attack patients.
While “the shares have struggled to recover since then,” the analyst points to a largely overlooked six-month data read-out from Capricor’s CAP-1002 HOPE-Duchenne trial, highlighting: “Don’t forget that the six-month HOPE look beat our expectations.” With new confidence thanks to “significant FDA visibility for the DMD program,” Pantginis now wagers that “catalysts next quarter could reinvigorate interest in the shares.”
Therefore, the analyst reiterates a Buy rating on CAPR stock while bumping up the price target from $2.15 to $6.50, which implies a close to 531% increase from where the stock is currently trading. (To watch Pantginis’ track record, click here)
Future share drivers that could lead to upside for Capricor include:
- 12-month data due from the HOPE-Duchenne trial
- A forthcoming presentation of the six-month HOPE data at a medical conference
- The initiation of a randomized, double-blind placebo-controlled Phase 2 DMD trial
Looking ahead, the analyst expects HOPE data could be presented in October at either the American Neurological Association conference, the European Society of Gene & Cell Therapy conference, or the American Society of Human Genetics conference.
Pantginis notes that with regard to the encouraging HOPE trial: “KOLs have indicated that the heart is quite involved in this advanced population and key to prolonged survival and that the data were impressive (especially with the clinical observation that the cardiac improvements coincided with skeletal muscle improvements).”
As “Fruitful discussions with FDA [ignite] the path forward” for Capricor, the analyst concludes commending positive FDA feedback on the DMD program, adding that the agency has pointed to CAPR’s existing nonclinical safety and efficacy database as “sufficient as support for the IND in incorporating repeat IV dosing.” Considering that the agency also delivered a Rare Pediatric Disease Designation to CAP-1002, Pantginis surmises that should the drug garner the green light, it “could be eligible for a Priority Review Voucher (several of which have been sold in the range of $125-350 million),” adding, “Two additional, and likely in our belief, designations which could be sought are Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) based on the continuing unmet medical need in DMD.”