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NVS

Novartis

$78.29

-0.16 (-0.20%)

14:44
10/09/16
10/09
14:44
10/09/16
14:44

Novartis reports Phase 3 data on LEE011 in breast cancer

Novartis announced that results from the pivotal Phase III MONALEESA-2 study show LEE011, or ribociclib, plus letrozole significantly extended progression-free survival compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone. The combination significantly improved PFS across all patient subgroups, regardless of disease characteristics or demographics. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% -- overall response rate in patients with measurable disease was 53% vs 37%. Most adverse events in the MONALEESA-2 trial were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and reduction. The discontinuation rate due to adverse events in the MONALEESA-2 trial was 7.5% for LEE011 plus letrozole and 2.1% for letrozole alone. The most common grade 3/4 adverse events were as follows for LEE011 plus letrozole compared to letrozole alone: neutropenia 60% vs 1%, leukopenia 21% vs 1%, elevated alanine aminotransferase 9% vs 1%, lymphopenia 7% vs 1%, and elevated aspartate aminotransferase 6% vs 1%. Due to the significant extension of PFS and clinical benefit seen with LEE011, analysis of the primary endpoint in MONALEESA-2 was stopped early in May as recommended by the Independent Data Monitoring Committee. Follow up to measure overall survival is ongoing.

NVS Novartis
$78.29

-0.16 (-0.20%)

08/31/16
LEER
08/31/16
NO CHANGE
Target $61
LEER
Outperform
Teva price target lowered to $61 from $66 at Leerink
Leerink analyst Jason Gerberry lowered his price target for Teva (TEVA) to $61 from $66 on loss of Copaxone patent challenge as an upside catalyst. The analyst believes Teva's share price implies a generic entrant sometime in the second half of 2017 after losing an Inter Partes Review decision on two Copaxone 40mg anchor patents. In order to mitigate EPS downside in 2017-2018 and eliminate business uncertainty, Gerberry thinks the company should settle its Copaxone patent dispute with Novartis (NVS) and Momenta (MNTA), which he sees as "the most credible" generic threat. The analyst reiterates an Outperform rating on Teva's shares.
08/31/16
PIPR
08/31/16
NO CHANGE
PIPR
Piper's Schimmer unsure of impact from Novartis CAR-T shakeup
Piper Jaffray analyst Joshua Schimmer said he's struggling with the implications of the news that Novartis (NVS) is reportedly eliminating its Cell and Gene Therapy unit as a stand-alone entity, which is primarily focused on development of CAR-T and adoptive immunotherapies. On the one hand, removing a leading competitor is a positive for the rest of the field, Schimmer tells investors in a research note. On the other hand, the move by Novartis could signal "significant challenges" in the field, the analyst adds. Schimmer continues to prefer companies "with unique and differentiated approaches," namely Bellicum Pharmaceuticals (BLCM), Cellectis (CLLS), Lion Biotechnologies (LBIO), Amgen (AMGN), Celgene (CELG) and bluebird bio (BLUE). Juno Therapeutics (JUNO) and Kite Pharma (KITE) are down 6% and 5%, respectively, in midday trading.
09/02/16
LEER
09/02/16
NO CHANGE
LEER
Outperform
Teva third Copaxone patent invalidated as expected, says Leerink
Leerink analyst Jason Gerberry says Teva (TEVA) suffered a largely expected loss in its Copaxone 40mg patent battle, with the Patent Trial and Appeal Board, or PTAB, ruling a third patent invalid. The analyst believes the company will likely appeal the loss, along with PTAB rulings rendered last week that other Copaxone patents were invalid. Gerberry sees the bull case scenario of Teva securing patent exclusivity of the Copaxone 40mg as unlikely and says a settlement with Momenta (MNTA) and Novartis (NVS) is the most logical course of action to mitigate 2017-2018E EPS risk. He reiterates an Outperform rating on Teva's shares.
09/20/16
CHDN
09/20/16
INITIATION
Target $95
CHDN
Buy
Novartis initiated with a Buy at Chardan
Chardan initiated Novartis with a Buy and a $95 price target.

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PROV

Provident Financial

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EPC

Edgewell Personal Care

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ORC

Orchid Island Capital

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AEP

American Electric

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ORC

Orchid Island Capital

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HBHC

Hancock Holding

$46.70

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First NBC Bank

$2.65

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TSLA

Tesla

$314.07

5.44 (1.76%)

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LMT

Lockheed Martin

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BA

Boeing

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WBA

Walgreens Boots Alliance

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GE

General Electric

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SIX

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LMT

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SBBP

Strongbridge Biopharma

$4.50

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CYH

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MRUS

Merus

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AEZS

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ANY

Sphere 3D

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Merus

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