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TSRO

Tesaro

$145.90

-1.34 (-0.91%)

05:28
01/12/17
01/12
05:28
01/12/17
05:28

TESARO receives CRL from FDA for rolapitant IV NDA

TESARO announced that the FDA has issued a Complete Response Letter, or CRL, regarding the rolapitant IV New Drug Application, or NDA, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. FDA requested additional information regarding the in vitro method utilized to demonstrate comparability of drug product produced at the two proposed commercial manufacturers for rolapitant IV that were included in the NDA. TESARO is working expeditiously to provide the requested information. The CRL did not identify concerns related to the safety or efficacy of rolapitant IV or request additional clinical studies. No concerns were raised regarding the active pharmaceutical ingredient, which is also used for the Varub oral product. TESARO identified potential deficiencies at the original contract manufacturer for rolapitant IV drug product, secured a second drug product supplier and included data from this manufacturer in the NDA. During the NDA review, FDA requested and TESARO provided in vitro data to demonstrate comparability of drug product made at the two manufacturing sites.

  • 30

    Jun

TSRO Tesaro
$145.90

-1.34 (-0.91%)

12/27/16
FBRC
12/27/16
NO CHANGE
Target $151
FBRC
Outperform
FBR Capital ups TESARO price target to $151
FBR Capital analyst Ed White raised his price target for TESARO to $151 from $133 and keeps the Outperform rating on the shares. The oncology-focused biopharmaceutical company closed Friday up $7.27 to $139.86. TESARO recently announced that the FDA has granted Priority Review for niraparib with a June 30, 2017 action date, White tells investors in a research note. He believes niraparib could be a potential blockbuster PARP inhibitor. Meanwhile, the launch of Varubi continues to "ramp up," with sequential quarter-over-quarter unit growth of 14%, the analyst writes. White says the drug achieved a 28% share of the oral NK-1 market in the U.S. in September.
01/04/17
GABE
01/04/17
NO CHANGE
GABE
Gabelli sees Incyte as more likely target following Gilead hire
Gilead (GILD) is more likely to buy Incyte (INCY) after naming Alessandro Riva to head its Hematology and Oncology Therapeutic unit, Gabelli analyst Jing He tells investors in a research note. Dr. Riva is a Novartis (NVS) veteran while Incyte is led by a team of Novartis veterans and has collaborated with Novartis Oncology on its key drug, Jakafi, the analyst points out. He believes Incyte is "big enough to move the needle" and bring long term growth to Gilead. The analyst lists Seattle Genetics (SGEN) and TESARO (TSRO) as other potential targets for the biotech giant. He believes Incyte is the "best fit."
01/09/17
LEER
01/09/17
NO CHANGE
Target $152
LEER
Outperform
TESARO price target raised to $152 from $115 at Leerink
Leerink analyst Seamus Fernandez raised his price target for TESARO to $152 from $115 to fully incorporate his high expectations for a broad label and reflect niraparib's transformation to a commercial stage asset. The analyst notes that the "strong data" from niraparib's NOVA trial, along with the lack of an expected FDA panel, should result in a broad label in the second-line or greater ovarian cancer maintenance setting, while ongoing niraparib trials in breast cancer and front-line ovarian cancer maintenance and the company's IO platform should be additional potential drivers of upside for the stock. Fernandez sees TESARO as an "attractive takeout target," and reiterates an Outperform rating on the shares.
01/10/17
LEER
01/10/17
NO CHANGE
LEER
Outperform
ARIAD acquisition supports potential takeout premium for TESARO, says Leerink
Leerink analyst Seamus Fernandez says the acquisition of ARIAD (ARIA) by Takeda (TKPYY) for $24 per share appears to be relatively in-line with other commercial stage acquisitions, and supports a potential acquisition price for TESARO (TSRO) of greater than $170 per share based on consensus forecasts. While TESARO remains well positioned to grow independently, the analyst believes a validated PARP inhibitor like niraparib could offer a durable and strategically important product opportunity for multiple suitors. He reiterates an Outperform rating on TESARO's shares.

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TAHO

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ATKR

Atkore

$18.42

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FTR

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PLYA

Playa Hotels & Resorts

$10.66

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HES

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APC

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