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HALO

Halozyme

$15.26

-0.07 (-0.46%)

, RHHBY

Roche

$0.00

(0.00%)

13:35
01/09/19
01/09
13:35
01/09/19
13:35

Halozyme expects three ENHANZE programs to be in phase 3 studies by year-end

Halozyme (HALO) provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1B in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application filed by ENHANZE partner Genentech, a member of the Roche Group (RHHBY), for the subcutaneous formulation of trastuzumab. In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab. Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target. By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1B in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1B, with $225M to $300M in revenues projected between 2019 and 2021. The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company's phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019. Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.

HALO

Halozyme

$15.26

-0.07 (-0.46%)

RHHBY

Roche

$0.00

(0.00%)

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HALO Halozyme
$15.26

-0.07 (-0.46%)

10/18/18
PIPR
10/18/18
INITIATION
Target $17
PIPR
Neutral
Halozyme assumed with a Neutral at Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro assumed coverage of Halozyme Therapeutics with a Neutral rating and $17 price target. While the analyst views the Enhanze technology as an "attractive platform that could drive substantial royalty revenue," he has near term concerns around the pivotal HALO-301 study. He believes HALO-301 will need to hit on both progression-free survival and overall survival to support approval and adoption, which tempers his expectations.
11/27/18
CANT
11/27/18
NO CHANGE
Target $27
CANT
Overweight
Halozyme modified Phase 3 design 'a good thing,' says Cantor Fitzgerald
Cantor Fitzgerald analyst Charles Duncan reiterates an Overweight rating and $27 price target on Halozyme Therapeutics after the company announced that it has made a request to the FDA to change the dual primary endpoints of progression free survival and overall survival of the HALO-301 study to the single primary endpoint of overall survival. On the surface, this "change" can quickly lead to a negative perception of trial progress, Duncan tells investors in a research note titled "Don't Miss the Forest for the Trees - Modified P3 is a Good Thing." However, when assessing the design and rationale, in conjunction with the study remaining blinded, the analyst views the move as "prudent, with the clinical risk thus having been reduced, at least, incrementally." He believes investors appreciate the high-risk in pancreatic cancer, and therefore see low expectations for Phase 3 success being priced into the current share price. Duncan says he has "enhanced non-zero conviction" in the potential for HALO-301 to read out positively in the second half of 2019.
11/27/18
JEFF
11/27/18
NO CHANGE
Target $9
JEFF
Underperform
Jefferies still sees low likelihood of success for Halozyme's PEGPH20
Following the announced change in the Phase 3 endpoint, Jefferies analyst Eun Yang continues to view probability for success of Halozyme Therapeutics's PEGPH20 in pancreatic cancer as low. The change in the HALO-301 endpoint/data analysis "dampens our confidence further," Yang tells investors in a research note. HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The analyst remains cautious on Halozyme shares with an Underpeform rating and $9 price target.
11/27/18
JMPS
11/27/18
NO CHANGE
Target $21
JMPS
Outperform
Halozyme Phase 3 trial amendment makes sense, says JMP Securities
After Halozyme announced that it is amending the design of the Phase 3 trial evaluating PEGPH20 in front-line pancreatic cancer to make overall survival the sole primary endpoint, JMP Securities analyst Jason Butler said he thinks the change makes sense and is neutral to his thesis. While the change pushes out first results by about 6-9 months, the "outcome will be definitive," said Butler, who reiterates an Outperform rating and $21 price target on Halozyme shares.
RHHBY Roche
$0.00

(0.00%)

12/17/18
PIPR
12/17/18
NO CHANGE
PIPR
Proteostasis deal with Genentech strenghtens balance sheet, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $14 price target on Proteostasis (PTI), noting the company announced an agreement with Roche's (RHHBY) Genentech to license small molecule modulators of an undisclosed target that lie outside of Cystic Fibrosis, which makes the company eligible for $100M in upfront and milestone payments plus royalties. Tenthoff sees this deal strengthening Proteostasis' balance sheet. Additionally, Tenthoff is optimistic on Proteostasis' TripleRx combo, and expects full Phase I TripleRx data in Q1 of 2019. Longer term, the analyst anticipates TripleRx approval in 2021, with global sales of $2.0B by 2026.
12/18/18
BERN
12/18/18
NO CHANGE
Target $288
BERN
Market Perform
Biogen drops after Bernstein sees potential downside of $100 on Q1 risks
Bernstein analyst Aaron Gal earlier today lowered his price target for Biogen (BIIB) to $288 from $341 while keeping a Market Perform rating on the shares. The Biogen "debate" revolves primarily around three elements: the durability of the existing franchises, the value of the company's Alzheimer's opportunity, and the potential of the pipeline to generate new drugs, Gal wrote in a research note. He believes the stock's current risk/reward balance "captures these dynamics." In Q1 of 2019, however, Biogen is facing "two significant risks," says the analyst. These are the inter partes review institution decision on its biggest drug, Tecfidera, and futility analyses of amyloid beta drugs - Roche's (RHHBY) crenezumab and potentially Biogen's own aducanumab, according to Gal. The analyst views Biogen's near-term risk/reward as "sharply negative." If a review of Tecfidera is instituted and one of the amyloid beta trials is stopped for futility, the stock "can easily" trade $100 per share lower, Gal believes. Even if one of these events goes against the company, the analyst thinks the Biogen can drop $30-$80 per share. On the other hand, passing both risks will likely only have "moderate upside" of around $30 per share as "both are assumed to be positive in sell-side consensus," Gal writes. He keeps a Market Perform rating on Biogen, which is down 7%, or $21.45, to $291.66 in afternoon trading.
12/20/18
PIPR
12/20/18
NO CHANGE
Target $400
PIPR
Overweight
Survey shows 'solid fundamentals' for Biogen MS franchise, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Biogen (BIIB) with a $400 price target after surveying 100 neurologists. The survey feedback shows "solid fundamentals" for the company's multiple sclerosis portfolio, Raymond tells investors in a research note. He admits, however, that many investors are preoccupied with Tecfidera's intellectual property situation. Nonetheless, neurologists reported meaningful share gains for Tecfidera and Tysabri this quarter, says the analyst. Raymond believes worries over the impact to Biogen's multiple sclerosis franchise from Roche's (RHHBY) Ocrevus launch "may be behind us."
01/02/19
JPMS
01/02/19
NO CHANGE
JPMS
JPMorgan adds Novo Nordisk to Analyst Focus List, removes Roche
JPMorgan analyst Richard Vosser added Novo Nordisk (NVO) to his firm's European Analyst Focus List while removing Roche (RHHBY).

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ARGO

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SP Plus Corp.

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18:20
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Ford

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Fiat Chrysler

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Honda

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Daimler AG

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SP

SP Plus Corp.

$36.62

0.15 (0.41%)

18:18
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LBY

Libbey

$5.75

0.15 (2.68%)

18:14
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LBY

Libbey

$5.75

0.15 (2.68%)

18:13
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NTES

NetEase

$232.66

3.11 (1.35%)

18:07
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CE

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Copart

$53.43

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WPG

Washington Prime

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CPA

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WPG

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$5.77

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17:46
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TFX

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