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MNK

Mallinckrodt

$16.59

0.85 (5.40%)

06:39
01/03/19
01/03
06:39
01/03/19
06:39

Mallinckrodt announces retrospective analysis of H.P. Acthar Gel published

Mallinckrodt announced publication of a retrospective analysis assessing the efficacy of H.P. Acthar Gel in kidney transplant recipients with treatment-resistant focal segmental glomerular sclerosis, or FSGS. FSGS is a rare disease that can cause nephrotic syndrome, a serious kidney disorder that may raise the risk of progression to end stage renal diseas, or ESRD. Results from the analysis, which included data from patients treated at two large U.S. transplant centers between April 2012 and December 2016, were published in the January issue of Transplantation. This retrospective study evaluated 20 kidney transplant patients who received H.P. Acthar Gel for the treatment of proteinuria due to new or recurrent post-transplant FSGS. Subjects had previously received conventional FSGS treatment with therapeutic plasma exchange or TPE, and/or rituximab and developed FSGS approximately three months after their transplant. Forty percent of patients received rituximab within 24 hours of the transplant surgery and 20% received TPE before transplantation. Seventy-five percent of patients were treated with TPE at the time of post-transplant FSGS; 50% received rituximab as well which was started before the use of H.P Acthar Gel. Eighty percent were treated with TPE and/or rituximab prior to initiating H.P. Acthar Gel therapy. All 20 patients in the study received thymoglobulin induction therapy. All patients were maintained on triple immunosuppression antirejection therapy of a calcineurin inhibitor, or CNI, mycophenolate mofetil and prednisone. Tacrolimus was used in 85% of patients and cyclosporine in 15%. One patient was switched from a CNI to belatacept because of CNI nephrotoxicity. Subjects took H.P. Acthar Gel twice a week for approximately six months and were evaluated for treatment response using the urine protein to creatinine ratio to determine complete or partial remission of proteinuria. Complete remission was defined as a decrease of proteinuria with stable kidney function and partial remission was defined as a lower decrease of proteinuria with stable kidney function. The analysis found significant improvement in proteinuria after treatment with H.P. Acthar Gel. Fifty percent of patients who received H.P. Acthar Gel had a complete or partial remission of proteinuria. The use of H.P. Acthar Gel did not significantly change mean serum creatinine levels or estimated glomerular filtration rate. Three patients died, one during treatment and two in the post-treatment follow-up period.

  • 10

    Jan

MNK Mallinckrodt
$16.59

0.85 (5.40%)

12/31/18
RILY
12/31/18
NO CHANGE
Target $21
RILY
Neutral
Mallinckrodt price target lowered to $21 from $37 at B. Riley FBR
B. Riley FBR analyst David Buck lowered his price target for Mallinckrodt to $21 after the company earlier this month announced plans to spin off a new company consisting of its specialty generics business and Amitiza to shareholders. The analyst keeps a Neutral rating on the shares.
12/17/18
MZHO
12/17/18
NO CHANGE
Target $22
MZHO
Neutral
Mallinckrodt price target lowered to $22 from $29 at Mizuho
Mizuho analyst Irina Koffler lowered her price target for Mallinckrodt to $22 while presenting an initial view of how to value the two separate companies. The analyst reduced estimates for Acthar and took a more "conservative stance" on Amitiza's long-term outlook. She also penalized the spin company $2 per share for estimated opioid liability. Koffler ascribes $16 per share to the branded business and $6 to the spin company. She reiterates a Neutral rating on Mallinckrodt.
12/07/18
WELS
12/07/18
NO CHANGE
Target $27
WELS
Market Perform
Mallinckrodt investor worries 'worthy of concern,' says Wells Fargo
Wells Fargo analyst David Maris attrubites the 7% selloff yesterday in shares of Mallinckrodt to investors recognizing that the spin-off process could take at least six months and the proceeds previously expected from a sale will now come in the form of levering the spin with debt. Furthering pressing the shares could the realiztioin that the company's opioid and environmental liabilities may not have been fully appreciated, Maris tells investors in a research note partially titled "Questions, But A Reasonable Alternative." The fact that the generics business now has to be consolidated after being reported as a discontinued operation, only to be taken out again when the spin is completed is also challenging for some investors, Maris writes. The analyst, while admitting Mallinckrodt's current cash flow is "very appealing," acknowledges that the re-consolidation and then spin of the generics unit, pending competition of Inomax in 2019, and investor worries about Acthar is "worthy of concern." He maintains a Market Perform rating on Mallinckrodt shares with a $27 price target.
12/07/18
PIPR
12/07/18
NO CHANGE
Target $39
PIPR
Overweight
Mallinckrodt generics spin-off 'least bad outcome,' says Piper Jaffray
In a research note titled "The Least Bad Outcome for the Generics Business," Piper Jaffray analyst David Amsellem reiterates an Overweight rating on Mallinckrodt with a $39 price target. Given that the generics segment is almost entirely a commodity business, Mallinckrodt not finding a buyer for its active pharmaceutical ingredient and specialty generics businesses is not all that surprising, Amsellem tells investors in a research note. He views yesterday's news of the company announcing a spin-off as the "least bad" outcome. The analyst reiterates an Overweight rating on Mallinckrodt with a $39 price target.

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