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CAPR

Capricor Therapeutics

$0.62

-0.007 (-1.11%)

07:07
01/22/19
01/22
07:07
01/22/19
07:07

Capricor Therapeutics announces outcome of FDA meeting for CAP-1002

Capricor Therapeutics announced that it had "positive" outcomes in its comprehensive multidisciplinary meeting with the FDA regarding development of the company's novel cell therapy candidate, CAP-1002, to treat Duchenne muscular dystrophy. Capricor met with the FDA in December 2018, as part of the expedited review afforded under the regenerative medicine advanced therapy, or RMAT, designation which the FDA granted to CAP-1002 in February 2018. During the meeting discussion and in subsequent meeting minutes, Capricor asked whether the FDA would agree to its current clinical trial, HOPE-2, serving as the registration study, if HOPE-2 provides evidence that CAP-1002 is safe and effective in treating Duchenne muscular dystrophy. The FDA advised Capricor to request an end of phase meeting after completion of the trial to determine whether HOPE-2 could serve as the registration study. The FDA also reiterated support for the use of the performance of the upper limb, or PUL, 2.0 mid-level test, which measures the ability to use arm and hand muscles, as the primary efficacy endpoint for HOPE-2. In addition, the agency stated that the trial would need to provide evidence of clinically meaningful changes in the PUL, as well as other evidence supportive of CAP-1002 efficacy for patients with advanced Duchenne muscular dystrophy, in order to serve as a registration trial.

CAPR Capricor Therapeutics
$0.62

-0.007 (-1.11%)

01/26/18
HCWC
01/26/18
NO CHANGE
Target $8.6
HCWC
Buy
Capricor Therapeutics price target raised to $8.60 from $6.50 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis raised his price target for Capricor Therapeutics to $8.60 following a meeting with management. The analyst increased his projected chance of success for CAP-1002 in Duchenne muscular dystrophy from 15% to 20% and reiterates a Buy rating on the shares.
05/16/18
MAXM
05/16/18
INITIATION
Target $7
MAXM
Buy
Capricor Therapeutics initiated with a Buy at Maxim
Maxim started Capricor Therapeutics with a Buy rating and $7 price target.
12/26/18
MAXM
12/26/18
DOWNGRADE
MAXM
Hold
Capricor Therapeutics downgraded to Hold from Buy at Maxim
Maxim analyst Jason McCarthy downgraded Capricor Therapeutics to Hold from Buy after the company announced that it has put its HOPE-2 clinical trial on a voluntary dosing hold pending an ongoing safety review due to a severe allergic reaction that occurred during patient infusion of blinded investigational product.
12/31/18
HCWC
12/31/18
NO CHANGE
Target $3.5
HCWC
Buy
Capricor price target lowered to $3.50 from $8.60 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis lowered his price target for Capricor Therapeutics to $3.50 after the company announced last week that it placed Hope-2 on a voluntary dosing hold following a severe allergic reaction during patient infusion of blinded investigational product. The analyst, however, keeps a Buy rating on the shares. He says the risk mitigation strategy being discussed is common among many infused therapeutics. The FDA should accept it, Pantginis believes, and he would be surprised if "further, more official, steps are taken in moving to a clinical hold at this point."

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