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MIST

Milestone Pharmaceuticals

$16.00

(0.00%)

07:07
08/13/19
08/13
07:07
08/13/19
07:07

Milestone Pharma announces regulatory updates for Etripamil pivotal program

Milestone Pharmaceuticals announced positive regulatory updates based on its interaction with the FDA that advance its pivotal program of etripamil, the Company's novel, potent and short-acting calcium channel blocker, in patients with paroxysmal supraventricular tachycardia or PSVT. "We are very encouraged by our most recent interaction with the FDA and remain well positioned for continued execution of our etripamil pivotal program in PSVT. Following this interaction, we now look forward to beginning enrollment in our NODE-303 open-label global safety study before the end of the year. Execution of our pivotal Phase 3 NODE-301 trial is also tracking ahead of our initial projections, and upsizing of the trial will enable us to satisfy a European Medicines Agency, or EMA, regulatory request, increase the study's power and potentially strengthen valuable sub-population analyses and pharmacoeconomic assessments, all while remaining on schedule to report topline data in the first half of 2020." Following interaction with the FDA, the Company announced several regulatory updates to its etripamil pivotal program in patients with PSVT.

  • 13

    Aug

MIST Milestone Pharmaceuticals
$16.00

(0.00%)

06/03/19
COWN
06/03/19
INITIATION
Target $32
COWN
Outperform
Milestone Pharmaceuticals initiated with an Outperform at Cowen
Cowen analyst Ritu Baral started Milestone Pharmaceuticals with an Outperform rating and $32 price target.
06/03/19
JEFF
06/03/19
INITIATION
Target $28
JEFF
Buy
Milestone Pharmaceuticals initiated with a Buy at Jefferies
Jefferies analyst Chris Howerton started Milestone Pharmaceuticals with a Buy rating and $28 price target. With positive Phase 2 data in-hand and a "well designed" pivotal program, the analyst sees a high likelihood of positive Phase 3 efficacy data in paroxysmal supraventricular tachycardia in mid-2020.
06/03/19
OPCO
06/03/19
INITIATION
Target $32
OPCO
Outperform
Milestone Pharmaceuticals initiated with an Outperform at Oppenheimer
Oppenheimer analyst Leland Gershell started Milestone Pharmaceuticals with an Outperform rating and $32 price target.
06/04/19
06/04/19
INITIATION
Target $32

Outperform
Oppenheimer bullish on Milestone Pharmaceuticals, initiates with an Outperform
As previously reported, Oppenheimer analyst Leland Gershell started Milestone Pharmaceuticals with an Outperform rating and $32 price target. The analyst notes that intranasal etripamil represents an important therapeutic advance as well as a means to reduce healthcare burden and expense. With Phase 3 results expected in the first half of 2020, Gershell is optimistic given "strong" Phase 2 efficacy, an adequate safety margin, and well-validated pharmacology. The analyst anticipates U.S. approval and launch by 2022, and models about $400M in 2026 U.S. sales in the PSVT indication.

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