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CAPR

Capricor Therapeutics

$1.92

-0.07 (-3.52%)

07:02
11/29/17
11/29
07:02
11/29/17
07:02

Capricor Therapeutics announces FDA clearance of IND for CAP-1002

Capricor Therapeutics announced that the U.S. FDA has cleared its Investigational New Drug application to conduct a new clinical trial of CAP-1002, its lead investigational therapy, in boys and young men in advanced stages of Duchenne muscular dystrophy, a fatal genetic disorder for which there are limited treatment options. This randomized, double-blind, placebo-controlled clinical trial will be called the HOPE-2 Trial and is designed to evaluate the safety and efficacy of intravenous, repeat doses of CAP-1002 in boys and young men whose ability to walk has been seriously impaired by the loss of muscle function that occurs as Duchenne muscular dystrophy progresses. The primary efficacy endpoint will be the relative change in the mid-level dimension of the Performance of the Upper Limb test from baseline to Month 12. The HOPE-2 Trial is expected to enroll approximately 84 patients and be conducted at 10-12 U.S. sites. Capricor believes that if the primary endpoint is reached, the HOPE-2 Trial could serve as a registration trial, meaning that its results could support the submission of a Biologics License Application to obtain marketing approval of CAP-1002. Capricor expects to initiate the HOPE-2 Trial in the first quarter of 2018. Capricor plans to apply for the Regenerative Medicine Advanced Therapy (RMAT) Designation for CAP-1002 based on updated guidance recently issued by the FDA. If granted, the RMAT Designation would be expected to facilitate CAP-1002's path to potential registration.

CAPR Capricor Therapeutics
$1.92

-0.07 (-3.52%)

02/13/17
RODM
02/13/17
INITIATION
Target $14
RODM
Buy
Capricor Therapeutics assumed with a Buy at Rodman & Renshaw
Rodman & Renshaw analyst Joseph Pantginis assumed coverage of Capricor Therapeutics with a Buy rating and $14 price target. The analyst believes the company has the potential to be a leader in cardiovascular regenerative medicine.
07/18/17
RODM
07/18/17
NO CHANGE
Target $2.15
RODM
Buy
FDA decision encouraging for Capricor Duchenne drug, says Rodman & Renshaw
Rodman & Renshaw analyst Joseph Pantginis notes that Capricor Therapeutics' CAP-1002 took an important regulatory step forward with the FDA granting Rare Pediatric Disease Designation for Duchenne muscular dystrophy. Should the positive CAP-1002 data continue to be positive and the therapy approved, Capricor could also be eligible for a Priority Review Voucher, or PRV, the analyst points out, adding that a key potential outcome to a PRV is not only an accelerated path to market, but the ability to sell the PRV for significant non-dilutive funding. Pantginis reiterates a Buy rating and $2.15 price target on the shares. In late morning trading, Capricor Therapeutics' stock has more than doubled to $1.44.
09/15/17
HCWC
09/15/17
NO CHANGE
Target $6.5
HCWC
Buy
Capricor Therapeutics price target raised to $6.50 from $2.15 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis raised his price target Capricor Therapeutics to $6.50 after increasing his projected chance of success for CAP-1002 in Duchenne muscular dystrophy to 15% from 5%. The analyst sees "significant" FDA visibility for the company's DMD program and believe catalysts next quarter could "reinvigorate interest in the shares." He keeps a Buy rating on Capricor.

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