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TESARO Inc (NASDAQ:TSRO)'s niraparib has received FDA approval, ahead of its Prescription Drug User Fee Act date of June 30.
Wedbush’s David M. Nierengarten reiterated an Outperform rating on the company, while raising the price target from $164 to $174.
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FDA Approval
“With firstmover advantage in the maintenance setting, a lack of requirement for a diagnostic, as well clinical data that is at least as good as Lynparza in gBRCA (damaged breast cancer gene) patients, we continue to believe that TSRO remains an attractive acquisition candidate,” the analyst mentioned.
Along with the FDA approval, there also are no genetic restriction on the niraparib label, which contains clinical data for the gBRCAmut (germline BRCA mutation carriers) and non-gBRCAmut cohorts with progression free survival (PFS) curves.
To be sold under the brand name ZEJULA, niraparib is expected to become available in later April, at which time the pricing will also be announced.
Market Expectations
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Nierengarten mentioned that the data from the SOLO-2 study for AstraZeneca plc (ADR) (NYSE:AZN)'s LYNPARZA in gBRCA patients revealed comparable PFS and hazard ration (HR) to niraparib’s NOVA trial.
“Given most ovarian cancer patients will be aware of their BRCA status already, we expect a relatively equal share of the gBRCA patient subset of ovarian cancer patients between ZEJULA and LYNPARZA, which we believe represent approximately 30 percent of the market,” the analyst went on to say.
However, given that ZEJULA has received approval in all patients, it is likely to gain a meaningfully larger share of the non-gBRCA market.
At last check in Tuesday's pre-market session, shares were up 5.76 percent at $165.75.
Related Links:
Tesaro Announces Expanded Development Program For Cancer Drug Niraparib, Stock Spikes Higher
Here Are The 4 Commercial Launches In 2017 That Earned Tesaro A Buy Rating At Argus
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.