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MNK

Mallinckrodt

$8.19

-0.23 (-2.73%)

17:23
07/16/19
07/16
17:23
07/16/19
17:23

Mallinckrodt halts Phase 2B trial investigating use of Acthar gel in ALS

Mallinckrodt announced that it is permanently discontinuing its Phase 2B study designed to assess the efficacy and safety of Acthar Gel as an investigational treatment for amyotrophic lateral sclerosis, or ALS. The drug is not FDA-approved for the ALS indication. Mallinckrodt made the decision to halt the trial after careful consideration of a recent recommendation by the study's independent Data and Safety Monitoring Board. The recommendation was based on the specific concern for pneumonia, which occurred at a higher rate in the ALS patients receiving Acthar Gel compared to those on placebo; the board also mentioned other adverse events specific to this patient population. The DSMB noted the proportion of patients who have completed Week 36 - the primary endpoint target - precludes a definitive determination of a treatment effect. The lack of a clear efficacy signal for this ALS patient population combined with the potential risk of pneumonia led to the board's recommendation.

  • 06

    Aug

  • 09

    Sep

MNK Mallinckrodt
$8.19

-0.23 (-2.73%)

06/12/19
CANT
06/12/19
NO CHANGE
Target $18
CANT
Overweight
Mallinckrodt price target lowered to $18 from $42 at Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen lowered her price target for Mallinckrodt to $18 from $42, driven by multiple contraction, given increasing headwinds from macro factors. While acknowledging that competition for Acthar could drive downside to her estimates and the consensus, the analyst reiterates an Overweight rating on the shares.
06/13/19
STFL
06/13/19
NO CHANGE
Target $24
STFL
Hold
Mallinckrodt's Acthar Phase 4 data shows 'strong' evidence in RA, says Stifel
Stifel analyst Annabel Samimy maintained a Hold rating and $24 price target on Mallinckrodt after the company released the full release of its two-part Phase 4 study of Acthar in refractory patients with persistent Rheumatoid Arthritis at EULAR, noting that both parts of the study hit all primary and secondary endpoints. In a research note to investors, Samimy says with these data that show "strong" clinical evidence in RA, she sees opportunity for Mallinckrodt to have more meaningful clinical discussions in third-party payer negotiations and greater validation with Medicare, both of which could support Acthar volumes going forward.
06/14/19
ADAM
06/14/19
NO CHANGE
Target $22
ADAM
Buy
Mallinckrodt price target lowered to $22 from $37 at Canaccord
Canaccord analyst Dewey Steadman lowered his price target on Mallinckrodt to $22 from $37 following the company's release of a blinded RA study showing Acthar's effectiveness. The analyst noted the data is the first of a string of expected Acthar data reads that he thinks can bolster and justify Acthar's use for exacerbations in highly refractory immune-modulated conditions. The price target reduction is based on a lower expected contribution from pipeline products. Steadman maintained his Buy rating on Mallinckrodt shares.
07/11/19
JEFF
07/11/19
NO CHANGE
Target $10
JEFF
Hold
Mallinckrodt price target lowered to $10 from $15 at Jefferies
Jefferies analyst Anthony Petrone lowered his price target for Mallinckrodt to $10 from $15 saying the latest Symphony Health prescription data show Acthar declines accelerating to mid-teens since the Centers for Medicare and Medicaid Services announced intentions to reduce the Medicaid base date average manufacturer price in late May. Although Medicaid is only ~10% of Acthar sales, the CMS announcement appears to be having a "chilling effect" on fill rates as the injunctive relief process under the Administrative Procedure Act evolves, Petrone tells investors in a research note. He lowered his estimates to reflect "ongoing uncertainties" and keeps a Hold rating on Mallinckrodt.

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LDL

Lydall

$20.30

0.395 (1.98%)

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Healthcare Services

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NASDAQ Market Internals

$0.00

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VRAY

ViewRay

$4.51

0.07 (1.58%)

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NYSE Market Internals

$0.00

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WWE

WWE

$70.18

0.53 (0.76%)

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  • 05

    Sep

MTRN

Materion

$60.32

1.2 (2.03%)

11:12
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Conference/Events
Materion management to meet with Sidoti »

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RMNI

Rimini Street

$4.87

0.02 (0.41%)

, ORCL

Oracle

$54.18

0.58 (1.08%)

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Rimini Street

$4.87

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ORCL

Oracle

$54.18

0.58 (1.08%)

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TEAM

Atlassian

$141.00

-1.62 (-1.14%)

11:05
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Options
Atlassian call volume above normal and directionally bullish »

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  • 20

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PANW

Palo Alto Networks

$195.32

-3.94 (-1.98%)

, SFTBF

SoftBank

$0.00

(0.00%)

11:04
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PANW

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$195.32

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SoftBank

$0.00

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Alphabet

$1,198.89

21.95 (1.87%)

GOOGL

Alphabet Class A

$1,201.61

22.92 (1.94%)

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EROS

Eros International

$1.31

0.005 (0.38%)

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PVTL

Pivotal Software

$13.97

-0.04 (-0.29%)

10:50
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Options
Long-dated Upside call Seller in Pivotal Software »

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  • 04

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U.S. corporate bond update: issuance is modest »

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PCG

PG&E

$10.21

-4.09 (-28.60%)

10:46
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NVTR

Nuvectra

$1.51

-0.12 (-7.36%)

10:45
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NTNX

Nutanix

$19.22

0.99 (5.43%)

10:45
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Nutanix call volume above normal and directionally bullish »

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CC

Chemours

$12.50

-0.18 (-1.42%)

10:35
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  • 23

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ARMK

Aramark

$40.98

3.91 (10.55%)

10:27
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SFDL

Security Federal Corp

$0.00

(0.00%)

10:25
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Security Federal Corp raises quarterly dividend to 10c per share »

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CGC

Canopy Growth

$26.74

-1.36 (-4.84%)

10:25
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Options
Canopy Growth call volume above normal and directionally bullish »

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CNMD

Conmed

$95.93

0.93 (0.98%)

10:25
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