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MDCO

The Medicines Co.

$51.92

1.03 (2.02%)

09:16
11/18/19
11/18
09:16
11/18/19
09:16

The Medicines Co. announces ORION-9 met all primary, secondary endpoints

The Medicines Co. announced detailed results from ORION-9, the last of three pivotal 18-month low-density lipoprotein cholesterol, or LDL-C, lowering Phase 3 clinical studies of inclisiran, an investigational twice-yearly therapy to reduce LDL-C and the first and only cholesterol-lowering treatment in the siRNA class. In ORION-9, twice-yearly dosing with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well-tolerated and demonstrated an excellent safety profile. Full study results were presented during a late-breaking science session at the American Heart Association, or AHA. For the primary endpoints of ORION-9, inclisiran delivered placebo-adjusted LDL-C reductions of 50% at day 510 in HeFH patients and demonstrated time-averaged placebo-adjusted LDL-C reductions of 45% from days 90 through 540. The overall adverse event profiles of the placebo- and inclisiran-treated groups in ORION-9 were similar. At least one serious treatment emergent adverse event was experienced by 13.8% of patients in the placebo-treated group and 7.5% of patients in the inclisiran-treated group. The incidences of deaths and malignancies were similar between the placebo and inclisiran groups, respectively. Low incidences of clinically significant elevations in liver function tests and serum creatinine increases were observed in the placebo and inclisiran groups, respectively, and none were considered related to study drug. Clinically relevant adverse events at the injection site, predominantly mild and always transient, were reported in 0.4% of placebo-treated patients vs. 13.7% of inclisiran-treated patients. ORION-9 data will be submitted to a peer-reviewed medical journal. The company expects to file regulatory submissions in the U.S. in Q4 and in Europe in Q1 of 2020.

MDCO The Medicines Co.
$51.92

1.03 (2.02%)

10/02/19
RILY
10/02/19
NO CHANGE
Target $95
RILY
Buy
The Medicines Co. price target raised to $95 from $74 at B. Riley FBR
B. Riley FBR analyst Mayank Mamtani raised his price target for The Medicines Co. (MDCO) to $95 from $74 and added the shares to FBR's Alpha Generator List. The analyst has "heightened conviction" in inclisiran taking a dominant market share in the anti-PCSK9 marketplace, particularly at the expense of Regeneron's (REGN) Praluent. Mamtani's penetration-share scenario analysis suggests worldwide peak sales of $4.1B to $8.0B. The analyst keeps a Buy rating on The Medicines Co. The stock is yet to still reflect last week's "strong" Phase III Orion program execution and evidence generation on safety, efficacy, and durability of effect to reaffirm inclisiran's differentiated clinical profile, Mamtani tells nivestors in a research note.
10/10/19
JEFF
10/10/19
DOWNGRADE
Target $50
JEFF
Hold
The Medicines Co. downgraded to Hold from Buy at Jefferies
Jefferies analyst Biren Amin downgraded The Medicines Co. to Hold from Buy with a price target of $50, up from $44.
10/10/19
JEFF
10/10/19
DOWNGRADE
Target $50
JEFF
Hold
Jefferies downgrades The Medicines Co. on 'aggressive' inclisiran estimates
Jefferies analyst Biren Amin downgraded The Medicines Co. to Hold from Buy with a price target of $50, up from $44. After We conducting a doctor survey, the analyst thinks inclisiran consensus estimates are "too aggressive" and that The Medicines Co shares appear fully valued. While inclisiran leads in market share for PCSK9i, it is essentially split between inclisiran and Repath, Amin tell investors in a research note after polling 50 cardiologists. Based on the feedback, he lowered his 2026 inclisiran sales estimate to $1.4B from $1.7B, below the current consensus at $2.6B.
10/31/19
JEFF
10/31/19
NO CHANGE
Target $50
JEFF
Medicines Co. 'going concern' language introduces added risk, says Jefferies
Jefferies analyst Biren Amin said new disclosures in The Medicines Company's 10-Q regarding 2022 convertible notes introduces an additional risk as the company's balance sheet is not strong and if holders convert by December the company could require additional near-term funding. The 10-Q stated that if the notes are called and the company can't raise sufficient funds that "there is substantial doubt about the company's ability to continue as a going concern," Amin pointed out. He keeps a Hold rating on Medicines Co. shares.

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